nitinol and Peripheral-Arterial-Disease

Endovascular treatment of peripheral arterial disease has emerged as a minimally-invasive alternative to surgical intervention and has often become the first-line therapy. The patency of these interventions has shown promise but has remained variable depending upon the location, length of lesion and device used for a particular treatment. Specifically, one of the most common locations that is treated with endovascular means for chronic-limb threatening ischemia is the femoropopliteal region. This area of the arterial tree is highly exposed to movements such as flexion, extension, and rotational torque; as such, placing metallic stents can result in kinking and damage to the stent, and subsequently the artery, over time. Stent characteristics are defined according to the metal property that composes them. Nitinol has been experimented with for use in the arterial tree since the 1980s namely because of its uniquely elastic mechanical properties, which were ideal for sustaining its shape within an anatomic area prone to positional variability. More recently, nitinol stents were introduced in an interwoven fashion, the design of which creates a scaffold of structure for the elastic property of the metal to remain reinforced within highly flexible arteries. This review article discusses the available literature and evidence behind the use of these interwoven nitinol stents in lower extremity peripheral arterial interventions.

Topics: Alloys; Femoral Artery; Humans; Peripheral Arterial Disease; Popliteal Artery; Prosthesis Design; Risk Factors; Stents; Treatment Outcome; Vascular Patency

Stenting of infrainguinal lesions can be rather challenging due to the mechanical stress applied on the arteries during motion. We assessed the short-term and mid-term safety and efficacy of Supera interwoven nitinol stent for the treatment of infrainguinal arterial disease.. We conducted a systematic review for articles published from December 2011 up to May 2021 regarding studies assessing the safety and efficacy of Supera interwoven nitinol stents for the treatment of infra-inguinal peripheral arterial disease. Studies that involved synchronous application of the Supera stent and drug delivering devices, or any alternative endoprosthesis were excluded. Pooled Kaplan-Meier survival curves and smoothed hazard estimates were generated. Data were meta-analyzed using a random effects model. Primary endpoints included primary patency and freedom from clinically driven target lesion revascularization (TRL). Secondary endpoints included technical success and major amputation at 1 year post intervention.. Seventeen studies with 2015 patients (65.3% males) and a mean lesion length of 137.2 mm were included. Of the total treated lesions, 44.9% involved femoropopliteal artery and 37.4% the popliteal artery. Chronic total occlusions made up 49% of the treated lesions. There were no stent fractures reported. The pooled technical success rate is 99.84% (95% CI: 99.26-100). Pooled major amputation rate at 1 year is 1.48% (95% CI: 0.47-2.87). Pooled primary patency and freedom from TLR rates at 1 year are 83.5% (95% CI: 80.24-86.54) and 90.32% (95% CI: 88.75-91.79), respectively. Pooling of individual patient data produced primary patency and freedom from TLR rates of 84.48% (95% CI: 82.66-86.11) and 90.81% (95% CI: 88.64-92.58) respectively. According to the smoothed hazard ratio estimate the risk for losing primary patency peaked between 4 and 5 months while the risk for TLR peaked between 7 and 8 months after the intervention.. This review and meta-analysis indicated the safety and efficacy of Supera stents for the treatment of challenging infrainguinal lesions in the short-term and mid-term periods, with acceptable primary patency and freedom from TLR rates. Clinicians should be aware that between 4 and 5 months patients face a higher risk for event occurrence.

Topics: Alloys; Female; Femoral Artery; Humans; Male; Peripheral Arterial Disease; Popliteal Artery; Prosthesis Design; Stents; Treatment Outcome; Vascular Patency

Primary nitinol stenting (PNS) and drug-coated balloon (DCB) angioplasty are two of the most common endovascular interventions for femoropopliteal atherosclerotic disease. Although many prospective randomized controlled trials have compared PNS or DCB with plain balloon angioplasty (POBA), no studies have directly compared PNS against DCB therapy. The purpose of this network meta-analysis is to determine whether there is a significant difference in outcomes between PNS and DCB.. The primary outcome measure was binary restenosis, the secondary outcome measures were target lesion revascularization (TLR) and change in the ankle-brachial index (ABI). Outcomes were evaluated at 6, 12, and 24 months. A literature review identified all randomized controlled trials published before March 2020 that compared DCB with POBA or PNS with POBA in the treatment of native atherosclerotic lesions of the femoropopliteal artery. Studies were excluded if they contained in-stent stenosis or tibial artery disease that could not be delineated out in a subgroup analysis. Network meta-analysis was performed using the network and mvmeta commands in STATA 14.. Twenty-seven publications covering 19 trials were identified; 8 trials compared PNS with POBA and 11 trials compared DCB with POBA. The odds of freedom from binary restenosis for patients treated with DCB compared with PNS at 6 months was 1.19 (95% confidence interval [CI], 0.63-2.22), at 12 months was 1.67 (95% CI, 1.04-2.68), and at 24 months was 1.36 (95% CI, 0.78-2.37). The odds of freedom from TLR for patients treated with DCB compared with PNS at 6 months was 0.66 (95% CI, 0.12-3.80), at 12 months was 1.89 (95% CI, 1.04-3.45), and at 24 months was 1.68 (95% CI, 0.82-3.44). The mean increase in ABI for patients treated with PNS compared with DCB at 6 months was 0.06 higher (95% CI, -0.03 to 0.15), at 12 months was 0.05 higher (95% CI, 0.00-0.09), and at 24 months was 0.07 higher (95% CI, -0.01 to 0.14).. Both DCB and PNS demonstrated a lower rate of binary restenosis compared with POBA at the 6-, 12-, and 24-month timepoints. When comparing DCB with PNS through network meta-analysis, DCB had a statistically lower rate of a binary restenosis and TLR at the 12-month timepoint. This network meta-analysis demonstrates that both DCB and PNS are superior to POBA, and that PNS is a satisfactory substitute for DCB when paclitaxel is not desirable.

Topics: Alloys; Angioplasty, Balloon; Ankle Brachial Index; Coated Materials, Biocompatible; Constriction, Pathologic; Femoral Artery; Humans; Network Meta-Analysis; Peripheral Arterial Disease; Popliteal Artery; Prosthesis Design; Randomized Controlled Trials as Topic; Recurrence; Risk Assessment; Risk Factors; Stents; Time Factors; Treatment Outcome; Vascular Access Devices

We conducted a network meta-analysis of randomized controlled trials comparing the efficacy and safety of multiple endovascular treatments for femoropopliteal lesions.. Nine treatments for femoropopliteal lesions were identified. We compared major amputation and all-cause mortality at 12-month follow-ups and primary patency at 6-, 12- and 24-month follow-ups of the treatments.. Altogether, 26 studies (52 study arms; 4102 patients) were considered eligible. In terms of primary patency, drug-eluting stent (DES) placement was the most effective treatment at 6- and 12-month follow-ups and covered stent (CS) placement at 24-month follow-ups, whereas directional atherectomy (DA) was the least effective treatment during all follow-up periods; both DES and CS placements were better than the majority of other single treatments, including balloon angioplasty, DA, nitinol stent (NS) placement and drug-coated balloon use, during all follow-up periods. In terms of 12-month major amputation and all-cause mortality, DA was the most safe treatment, whereas NS placement was the least safe single treatment.. DES and CS placements have shown encouraging results in terms of primary patency for femoropopliteal lesions, DES placement performs better within 12 months after operation and CS placement at approximately 24 months, while DA seems to be less effective. DA may be better than other treatments in terms of major amputation and all-cause mortality, while NS seems to be less safe.

Topics: Alloys; Amputation, Surgical; Angioplasty, Balloon; Atherectomy; Drug-Eluting Stents; Endovascular Procedures; Female; Femoral Artery; Humans; Male; Middle Aged; Network Meta-Analysis; Peripheral Arterial Disease; Popliteal Artery; Randomized Controlled Trials as Topic; Stents; Treatment Outcome

Topics: Alloys; Angioplasty, Balloon; Constriction, Pathologic; Device Approval; Drug-Eluting Stents; Femoral Artery; Humans; Peripheral Arterial Disease; Popliteal Artery; Stents; Treatment Outcome; Vascular Patency

Femoropopliteal atherosclerosis affects a significant percentage of the world population, leading to intermittent claudication and critical limb ischemia. The femoropopliteal segment has a unique set of biomechanical challenges that must be considered and overcome for treatment. The use of stents is a reality and a necessity in peripheral interventions. The success of first-generation femoropopliteal stents was limited by their rigidity and deformability. The standard nitinol stents overcame certain biomechanical challenges because of their superelasticity and thermal shape memory, although stent fracture is still an issue. Therefore, interwoven nitinol stents with helical structure have been developed, borrowing the concept from biliary stents, aiming to provide good flexibility while still maintaining a uniform cell size and significant radial strength. This unique interwoven structure gains it advantage in the femoropopliteal region. The purpose of this review article is to investigate the current published evidence of the use of self-expandable interwoven nitinol stents in femoropopliteal arterial disease and compare them with other endovascular treatment options.

Topics: Alloys; Endovascular Procedures; Femoral Artery; Hemodynamics; Humans; Peripheral Arterial Disease; Popliteal Artery; Prosthesis Design; Prosthesis Failure; Risk Assessment; Risk Factors; Self Expandable Metallic Stents; Stress, Mechanical; Treatment Outcome

Endovascular stenting has matured into a commonly used treatment for peripheral arterial disease (PAD) due to its minimally invasive nature and associated reductions in short-term morbidity and mortality. The mechanical properties of the superelastic Nitinol alloy have played a major role in the explosion of peripheral artery stenting, with modern stents demonstrating reasonable resilience and durability. Yet in the superficial femoral and popliteal arteries, even the newest generation Nitinol stents continue to demonstrate clinical outcomes that leave significant room for improvement. Restenosis and progression of native arterial disease often lead to recurrence of symptoms and reinterventions that increase morbidity and health care expenditures. One of the main factors thought to be associated with stent failure in the femoropopliteal artery (FPA) is the unique and highly dynamic mechanical environment of the lower limb. Clinical and experimental data demonstrate that the FPA undergoes significant deformations with limb flexion. It is hypothesized that the inability of many existing stent designs to conform to these deformations likely plays a role in reconstruction failure, as repetitive movements of the leg and thigh combine with mechanical mismatch between the artery and the stent and result in mechanical damage to both the artery and the stent. In this review we will identify challenges and provide a mechanical perspective of FPA stenting, and then discuss current research directions with promise to provide a better understanding of Nitinol, specific features of stent design, and improved characterization of the biomechanical environment of the FPA to facilitate development of better stents for patients with PAD.

Topics: Alloys; Animals; Blood Vessel Prosthesis; Femoral Artery; Humans; Peripheral Arterial Disease; Popliteal Artery; Prosthesis Design; Stents

We describe a case of an infected popliteal artery stent with septic emboli presenting 6 years after peripheral vascular intervention for intermittent claudication. Management included resection of the stent and popliteal artery and revascularization by femoral-popliteal bypass with autogenous vein. This case demonstrates that peripheral stent infections can develop years after intervention. We performed an English-language PubMed literature review of arterial peripheral vascular stent infections on using the search term, "Non-coronary stent or stent graft infection from 1966 to present." Written informed consent was obtained for publication.

Topics: Aged; Alloys; Angioplasty; Computed Tomography Angiography; Device Removal; Female; Femoral Artery; Humans; Peripheral Arterial Disease; Popliteal Artery; Prosthesis Design; Prosthesis-Related Infections; Saphenous Vein; Self Expandable Metallic Stents; Treatment Outcome; Ultrasonography, Doppler, Duplex

The superficial femoral artery is a complex artery subject to a unique set of biomechanical loading conditions in its course through the leg. Plain balloon angioplasty and balloon-expandable stents had unacceptably high rates of restenosis, necessitating target vessel revascularization. Nitinol alloy is well suited to provide the strength and flexibility needed of stents to withstand the external forces posed by the environment of the superficial femoral artery. Advances in stent technology with the addition of a slow-releasing antiproliferative agent and changes in scaffold design have shown promise in reducing the rates of stent fracture and in-stent restenosis.

Topics: Alloys; Femoral Artery; Humans; Peripheral Arterial Disease; Prosthesis Design; Self Expandable Metallic Stents; Vascular Surgical Procedures

The factors that impact the clinical effectiveness of bare nitinol stents in claudicants with symptomatic femoropopliteal atherosclerosis are incompletely known. The authors analyzed variables that may influence stent durability and provide a benchmark for their effectiveness. Data analyzed from six studies (999 patients) included baseline noninvasive hemodynamic tests, angiographic characteristics, ultrasound defined stent patency and target lesion revascularization through 12-months. Baseline ankle-brachial index and lesion length predicted stent patency and target lesion revascularization and when combined interacted significantly to better predict outcomes. This meta-analysis provides an important comparator against which emerging therapies that treat claudicants with femoropopliteal atherosclerosis can be assessed.. Peripheral Artery Disease BACKGROUND: The performance of bare metal nitinol stents in patients with symptomatic femoropopliteal peripheral artery disease (PAD) is not well defined.. Patient-level data from six large prospective trials sponsored by medical device manufacturers was abstracted and analyzed to identify a cohort of patients with claudication and femoropopliteal artery occlusive disease. Twelve-month binary patency and target lesion revascularization (TLR) rates were primary outcomes. Stent patency was assessed by duplex ultrasonography (DUS) and TLR was a clinically driven intervention. To characterize the effects of patient characteristics on the outcomes, meta-regression was performed via mixed effects logistic regression models with patient-level covariates.. About 999 patients were analyzed; the mean ABI was 0.68 ± 0.18, the mean lesion length was 84 ± 53 mm, the mean lesion stenosis was 78%, and nearly two thirds of patients had mild to severe calcification. The mean Rutherford clinical category was 2.7 ± 0.6 and ranged from 2.6 to 2.8 in all studies. The 12-month patency across all studies was 69.8% and TLR rates ranged from 9.2% to 19.7%. Multivariable analysis demonstrated that baseline ABI and baseline target lesion length predicted both primary patency and TLR. Further, these two variables interacted significantly to better predict TLR outcomes when used in combination.. The 12-month clinical effectiveness of bare nitinol stents to treat patients with symptomatic femoropopliteal PAD is acceptable and is impacted by clinical and lesion-specific characteristics. These data provide an important and useful benchmark to compare the clinical benefit of emerging endovascular PAD therapies. © 2017 Wiley Periodicals, Inc.

Topics: Aged; Alloys; Ankle Brachial Index; Clinical Trials as Topic; Endovascular Procedures; Female; Femoral Artery; Humans; Intermittent Claudication; Male; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Prosthesis Design; Risk Factors; Stents; Time Factors; Treatment Outcome; Vascular Patency

Amassed evidence from several randomized controlled trials and high quality meta-analyses clearly support the primary use of paclitaxel-coated balloons (PCB) in the superficial femoral artery over traditional plain balloon angioplasty or primary bare nitinol stenting with significantly lower vascular restenosis, less need for repeat procedures, improved quality of life and potential cost savings for the healthcare system. Stents may be reserved for bail-out in case of a suboptimal dilatation result, and for selected more complex lesions, or in case of critical limb ischemia in order to eliminate vessel recoil and maximize immediate hemodynamic gain. Debulking atherectomy remains unproven, but holds a lot of promise in particular in combination with PCBs, in order to improve compliance of the vessel wall by plaque removal, allow for a better angioplasty result and optimize drug transfer and bioavailability. The present overview summarizes and discusses current evidence about femoropopliteal PCB angioplasty compared to the historical standard of plain old balloon angioplasty and bare nitinol stents. Available evidence is appraised in the context of clinically meaningful results, relevant unresolved issues are highlighted, and future trends are discussed.

Topics: Alloys; Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Constriction, Pathologic; Cost-Benefit Analysis; Female; Femoral Artery; Health Care Costs; Humans; Male; Middle Aged; Paclitaxel; Peripheral Arterial Disease; Prosthesis Design; Stents; Treatment Outcome; Vascular Access Devices

The efficacy and safety of primary stenting for superficial femoral artery (SFA) disease have been benchmarked against historically derived performance goals. However, contemporary evidence evaluating SFA stenting is accumulating. The objective of this systematic review and meta-analysis was to quantitatively assess outcomes after primary SFA stenting with nitinol stents in contemporary practice, to compare these rates with commonly used efficacy and safety goals, and to discuss the clinical and regulatory implications of these findings.. We searched MEDLINE, the US Food and Drug Administration (FDA) website, reference lists of qualifying articles, and conference proceedings until October 2012. Studies prospectively assessing primary nitinol stenting for diseased SFA were sought. Data from 11 prospective clinical trials were included. The twelve-month primary patency (PP) rate was reported in five trials. The meta-analytic 12-month PP rate was 71.6% (95% confidence interval [CI] 66.4-76.7%). The meta-analytic rate of 30-day freedom from a composite of death, target limb amputation, and reintervention was 99.9% (95% CI 100.0-90.0%).. Contemporary nitinol-based bare-metal stents performed well in controlled settings. Occurrence of the 1-month composite safety endpoint was extremely uncommon.

Topics: Alloys; Constriction, Pathologic; Endovascular Procedures; Femoral Artery; Humans; Peripheral Arterial Disease; Popliteal Artery; Prosthesis Design; Risk Factors; Stents; Treatment Outcome; Vascular Patency

Excisional atherectomy alone or followed by stenting is considered an appropriate treatment strategy for patients with lifestyle-limiting claudication due to obstructive infra-inguinal peripheral arterial disease (Ramaiah et al., J Endovasc Ther 2006;13:592-6021). We present a case of a 69-year-old man with eccentric severely calcified disease of the superficial femoral artery (SFA) treated with excisional atherectomy followed by stenting with an interwoven nitinol stent. The procedure was complicated by extravascular stent migration associated with a contained rupture presenting 30 days after the intervention. The complication was successfully treated with a stent graft. Although rare, pseudoaneurysms have been reported at the site of prior atherectomy; however, this case is the first description of a contained rupture post atherectomy associated with erosion of a nitinol stent into an extra-luminal position. The mechanism and management of this complication are discussed.

Topics: Aged; Alloys; Angioplasty, Balloon; Atherectomy; Blood Vessel Prosthesis Implantation; Femoral Artery; Foreign-Body Migration; Humans; Male; Peripheral Arterial Disease; Prosthesis Design; Radiography; Rupture; Severity of Illness Index; Stents; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Color; Ultrasonography, Interventional; Vascular Calcification; Vascular System Injuries

Several randomized controlled trials (RCTs) have shown the superiority of some of these technologies over balloon angioplasty, but direct comparisons between these treatment options are lacking. The authors conducted a network meta-analysis of RCTs comparing bare nitinol stents, covered nitinol stents, paclitaxel- or sirolimus-eluting stents (PES or SES), and paclitaxel-coated balloons (PCB) with plain balloon angioplasty or with each other in the femoropopliteal artery (PROSPERO registry: CRD42013004845).. Sixteen RCTs comprising 2532 patients with 4227 person-years of follow-up were analyzed on an intention-to-treat basis. Bayesian random effects Poisson and binomial models were used for mixed treatment comparisons (WinBUGS). Clinical heterogeneity was accounted for by incorporating a meta-regression model on trial-specific baseline risk. End points included technical success, vascular restenosis, target lesion revascularization, and major amputations. Pairwise odds ratios and rate ratios (ORs and RRs) of absolute treatment effects were calculated, and the probabilities of each treatment being best are reported. Summary estimates are reported as the posterior median and associated credible intervals (CrIs) that serve the same purpose as confidence intervals in the context of the Bayesian framework. Extensive sensitivity, meta-regression, and network consistency analyses were performed to evaluate heterogeneity.. Technical success was highest with covered stents (pooled OR, 13.6; 95% CrI, 3.3-31.1, probability best 82%) followed by uncovered stents (pooled OR, 7.0; 95% CrI, 2.6-129, probability best 18%) when compared with balloon angioplasty (reference treatment). Vascular restenosis was lowest with PES (RR, 0.43; 95% CrI, 0.16-1.18, probability best 45%) followed by PCB (RR, 0.43; 95% CrI, 0.26-0.67, probability best 42%). Target lesion revascularization was lowest with PCB (RR, 0.36; 95% CrI, 0.23-0.55, probability best 56%) followed by PES (RR, 0.42; 95% CrI, 0.16-1.06, probability best 33%). Major amputations were rare in all treatment and control groups (pooled amputation rate of 0.7 events per 100 person-years).. Immediate technical success is better with the use of covered stents, whereas paclitaxel-eluting stents and paclitaxel-coated balloons offer the best long-term results in the femoropopliteal artery.

Topics: Alloys; Amputation, Surgical; Angioplasty, Balloon; Bayes Theorem; Cardiovascular Agents; Coated Materials, Biocompatible; Constriction, Pathologic; Drug-Eluting Stents; Equipment Design; Femoral Artery; Humans; Limb Salvage; Odds Ratio; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Prosthesis Design; Randomized Controlled Trials as Topic; Recurrence; Risk Factors; Sirolimus; Stents; Treatment Outcome; Vascular Access Devices

The performance of self-expanding interwoven nitinol stent (Supera) in femoropopliteal interventions has been proven through trials with short lesions and with relatively low proportion of occlusions. There is limited evidence of Supera stent in long lesions. The aim of this study was to assess the clinical safety and efficiency of the Supera stent in the treatment of long femoropopliteal lesions (Trans-Atlantic Inter-Society Consensus [TASC] C/D) in patients with symptomatic peripheral arterial disease (PAD).. The STELLA SUPERA (STEnting Long de L'Artère fémorale superficielle par le stent métallique Supera) is a prospective, 2-center, single-arm study. Patients with symptomatic (Rutherford stages 2-6) de novo and TASC C/D lesions of the femoropopliteal segment were treated with Supera stent. The primary endpoint was the primary sustained clinical improvement at 12 months. Follow-up included clinical examination, duplex scan, and biplane X-ray up to 24 months.. Between December 2016 and October 2018, 48 symptomatic patients with 49 femoropopliteal lesions (TASC D = 32, 65%) were treated. The mean lesion length was 234 ± 123 mm, and 78% were total occlusion. The mean stented lesion length was 273 ± 127 mm. At 12 and 24 months, the primary sustained clinical improvement rate was 87.2% and 79.7%, respectively. The Rutherford category assessment was significantly improved at 24 months compared with baseline (p=0.02). At 24 months, the primary patency and freedom from target lesion revascularization (TLR) rates were 77.9% and 86.9%, respectively. The ankle-brachial pressure index increased from 0.62 ± 0.15 at baseline to 0.93 ± 0.15 at 24 months (p<0.0001). There were no stent fractures at 24 months.. The use of Supera stent in long lesions (TASC C/D) is a safe and effective endovascular alternative. These results reinforce the need for randomized clinical trials to assess the value of interwoven stents for long femoropopliteal lesions.

Topics: Femoral Artery; Humans; Peripheral Arterial Disease; Popliteal Artery; Prospective Studies; Prosthesis Design; Stents; Treatment Outcome; Vascular Patency

The aim of this study was to compare technical success, patency rates and clinical outcomes of vein bypass (VBP) with angioplasty and nitinol stents (NS) in femoropopliteal Trans-Atlantic Intersociety Consensus (TASC) II C and D lesions.. Guidelines widely recommend an endovas-cular-first strategy for long femoropopliteal lesions without sufficient data comparing it with vein bypass surgery.. A single-center prospective, randomized controlled trial (RCT) was performed, after approval of the local ethics committee, with technical success, primary and secondary patency as primary endpoints. Secondary endpoints were limb salvage, survival, complications, and clinical improvement.. Between 2016 and 2020, 218 limbs (109 per group) in 209 patients were included. Baseline and lesion characteristics were similar in both groups with a mean lesion length of 268 mm. The indication for treatment was chronic limb threatening ischemia in 53% of limbs in both groups. Technical success was feasible in 88% in the stent group. During a 4-year follow-up, primary patency, freedom from target lesion revascularizations, limb salvage, survival and complications showed no significant differences between the groups. At 48 months secondary patency for the bypass group was 73% versus 50% in the stent group ( P = 0.021). Clinical improvement was significantly superior in the bypass group with 52% versus 19% reaching a Rutherford 0 category ( P < 0.001).. This is the largest RCT comparing angioplasty with NS and vein bypass in femoropopliteal TASC II C and D lesions and the first to report 4-year results. The data underline the feasibility of endovascular treatment in long lesions but also emphasize the advantages of VBP.

Topics: Humans; Peripheral Arterial Disease; Popliteal Artery; Retrospective Studies; Stents; Treatment Outcome; Vascular Patency

Effective and durable options for infrapopliteal artery revascularization for patients with chronic limb-threatening ischemia (CLTI) are limited.. The SAVAL trial is a prospective, multicenter, randomized trial of patients with CLTI and infrapopliteal artery lesions with total lesion length ⩽ 140 mm, stenosis ⩾ 70%, and Rutherford category 4-5 assigned 2:1 to treatment with the SAVAL self-expandable paclitaxel drug-eluting stent (DES) or percutaneous transluminal angioplasty (PTA) with an uncoated balloon. The primary effectiveness endpoint was primary vessel patency (i.e., core lab-adjudicated duplex ultrasound-based flow at 12 months in the absence of clinically driven target lesion revascularization or surgical bypass of the target lesion). The primary safety endpoint was the 12-month major adverse event (MAE)-free rate; MAEs were defined as a composite of above-ankle index limb amputation, major reintervention, and 30-day mortality. The endpoints were prespecified for superiority (effectiveness) and noninferiority (safety) at a one-sided significance level of 2.5%.. A total of 201 patients were enrolled and randomly assigned to treatment (. The SAVAL trial did not show benefit related to effectiveness and safety with the nitinol DES compared with PTA in infrapopliteal artery lesions up to 140 mm in length. Continued innovation to provide optimal treatments for CLTI is needed.

Topics: Angioplasty; Angioplasty, Balloon; Drug-Eluting Stents; Humans; Ischemia; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Prospective Studies; Stents; Treatment Outcome; Vascular Patency

This prospective, multicenter, randomized study aimed to compare the 1-year clinical outcomes after primary stenting with self-expanding bare metal nitinol stent (SENS) and plain old balloon angioplasty (POBA) in patients with critical limb ischemia (CLI) and below-the-knee (BTK) lesions. Overall, 119 patients with CLI and BTK lesions were randomized to POBA alone (POBA group, 61 patients) or primary stenting with SENS (stenting group, 58 patients) after achieving acceptable POBA results in target BTK lesions. Clinical outcomes including amputation and revascularization rates were prospectively compared for 1 year. After 1 year, similar incidence rates of individual clinical endpoints, including cardiac death (6.5% vs. 5.1%, p > 0.999), myocardial infarction (1.6% vs. 0.0%, p > 0.999), repeat revascularization (19.6% vs. 18.9%, p = 0.922), target lesion revascularization (13.1% vs. 17.2%, p = 0.530), and amputation (4.9% vs. 0.0%, p = 0.244), were observed. POBA appeared to have acceptable treatment outcomes compared with primary stenting with SENS after 1 year in CLI patients with BTK lesions undergoing percutaneous transluminal angioplasty (PTA).

Topics: Angioplasty, Balloon; Angioplasty, Balloon, Coronary; Humans; Peripheral Arterial Disease; Popliteal Artery; Prospective Studies; Stents; Treatment Outcome; Vascular Patency

Topics: Alloys; Consensus; Endovascular Procedures; Humans; Peripheral Arterial Disease; Popliteal Artery; Retrospective Studies; Risk Factors; Stents; Treatment Outcome; Vascular Patency

Topics: Aged; Alloys; Disease-Free Survival; Drug-Eluting Stents; Female; Femoral Artery; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Patient Safety; Peripheral Arterial Disease; Popliteal Artery; Prosthesis Design; Reproducibility of Results; Sirolimus; Treatment Outcome

This study sought to compare patency rates and clinical outcomes of nitinol stents and primary vein bypass in long femoropopliteal lesions.. An endovascular-first strategy for long femoropopliteal lesions is widely recommended without sufficient data comparing it with bypass surgery. Nitinol stents are widely used as the standard endovascular therapy.. A single-center randomized controlled trial was performed with the primary endpoints of technical success, primary and secondary patency. Secondary endpoints were limb salvage, survival, complications, and clinical improvement.. A total of 110 limbs (55 per group) in 103 patients were treated. Baseline and lesion characteristics were similar, with a mean lesion length of 276 mm. Critical limb threatening ischemia was the indication for treatment in 49% of limbs in both groups. Technical success was achieved in 87% in the stent group. During a 2-year follow-up, patency rates, limb salvage, survival and complications showed no significant differences between both groups. At 24 months, primary and secondary patency rates for the stent group were 60% and 72% versus 56% and 73% in the bypass group, respectively. Clinical improvement was significantly better in the bypass group.. There were no significant differences regarding patency rates, limb salvage, survival, or complications after 2 years. Technical success and clinical improvement in the bypass group were significantly better, but the promising results of the stent group suggest that an endovascular-first strategy for femoropopliteal lesions up to 30 cm may be reasonable. Mid- as well as long-term results need to be awaited.

Topics: Aged; Alloys; Angioplasty, Balloon; Austria; Female; Femoral Artery; Humans; Limb Salvage; Male; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Saphenous Vein; Stents; Time Factors; Treatment Outcome; Vascular Grafting; Vascular Patency

The EVOLUTION Study is a prospective, non-randomized study, investigating the iVolution stent (iVascular, Barcelona, Spain). The study was conducted at the vascular departments of four hospitals in Belgium. This manuscript reports the findings up to 12-month follow-up time for the total cohort. The primary endpoint of the study is primary patency at 12 months. Primary patency is defined as a target lesion without a hemodynamically significant stenosis on duplex ultrasound (>50%, systolic velocity ratio no greater than 2.4) and without Target Lesion Revascularization (TLR) within 12 months.. Between April 2015 and November 2016, 120 patients with TASC A&B femoropopliteal lesions were included. The mean lesion length was 89.63 mm. Most of the lesions were stenotic lesions (60.00%).. Primary patency rate for the total patient population was 86.30% at 12-month follow-up. Freedom from TLR at 12-month was 88.00%.. These results confirm the already existing enthusiasm of the use of bare metal self-expandable nitinol stents in the treatment of TASC A&B femoropopliteal lesions. Longer follow-up and a comparison or addition with drug-eluting technology has to be studied in the future.

Topics: Adult; Aged; Aged, 80 and over; Alloys; Angioplasty, Balloon; Endovascular Procedures; Female; Humans; Male; Middle Aged; Peripheral Arterial Disease; Prospective Studies; Self Expandable Metallic Stents; Vascular Patency

To report the midterm outcomes of a trial comparing self-expanding nitinol stents to percutaneous transluminal angioplasty (PTA) with provisional stenting in the treatment of obstructive disease in the superficial femoral and popliteal arteries.. The SM-01 study ( ClinicalTrials.gov identifier NCT01183117), a single-blinded, multicenter, randomized controlled trial in Japan, enrolled 105 consecutive patients with de novo or postangioplasty restenotic femoropopliteal lesions; after removing protocol violations (1 from each group), 51 patients (mean age 74±8 years; 36 men) in the stent group and 52 patients (mean age 73±8 years; 35 men) in the PTA group were included in the intention-to-treat analysis. The groups were well-matched at baseline. Patients were followed to 36 months with duplex imaging. Three-year primary patency was assessed based on a duplex-derived peak systolic velocity ratio <2.5. Freedom from clinically-driven target vessel revascularization (TVR) and target lesions revascularization (TLR) were estimated using the Kaplan-Meier method.. The technical success rate was higher (100% vs 48%, p<0.001) and the frequency of vascular dissection was lower (4% vs 31%, p<0.001) in the stent group. The S.M.A.R.T stent group had a higher 3-year primary patency rate (73% vs 51%, p=0.033). Freedom from clinically-driven TVR and TLR were not significantly different between the groups.. The S.M.A.R.T. stent maintained a higher primary patency rate than PTA at 3 years in this randomized trial; the need for clinically-driven revascularization was similar for both therapies.

Topics: Aged; Aged, 80 and over; Alloys; Angioplasty, Balloon; Female; Femoral Artery; Humans; Japan; Male; Peripheral Arterial Disease; Popliteal Artery; Prospective Studies; Prosthesis Design; Recurrence; Self Expandable Metallic Stents; Single-Blind Method; Time Factors; Treatment Outcome; Vascular Patency

Optimal stenting strategy for long femoropopliteal artery lesions still remains undefined. Longer stent length has been shown to be associated with increased risk of restenosis. We sought to compare the efficacy of spot versus long stenting in the treatment of femoropopliteal artery disease.. This study was designed as a multicenter randomized controlled trial to compare immediate and mid-term outcomes of spot versus long primary stenting for femoropopliteal arterial lesions. A total of 125 patients were randomized 1:1 to spot stenting group (n = 59) or long stenting group (n = 66).. All lesions were treated with self-expanding bare nitinol stents. Baseline clinical and lesion characteristics were similar between the 2 groups except for male gender and current smoker. The mean lesion length was 24.1 ± 8.8 cm. Technical success was achieved in all patients. The 1-year primary patency and TLR-free (target lesion revascularization) survival did not differ significantly between the 2 groups. However, the spot stenting group showed a trend toward higher primary patency (86.1% vs. 72.7%, P = 0.158) and TLR-free survival (94.2% vs. 82.5%, P = 0.120). The total stented length (hazard ratio [HR] 1.01, 95% confidence interval [CI] 1.00-1.01, P = 0.011) and age (HR 0.94, 95% CI 0.90-1.00, P = 0.035) were independent predictors of restenosis.. The spot stenting appears to be more favorable than the long stenting in terms of primary patency and TLR-free survival, although the difference was not statistically significant. The stented length was an independent predictor of restenosis.

Topics: Aged; Alloys; Angioplasty, Balloon; Constriction, Pathologic; Female; Femoral Artery; Humans; Male; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Progression-Free Survival; Prosthesis Design; Recurrence; Republic of Korea; Risk Factors; Self Expandable Metallic Stents; Time Factors; Vascular Patency

To evaluate the safety and effectiveness of the TIGRIS stent for lesions up to 24 cm in the superficial femoral and proximal popliteal arteries (SFA/PPA).. This prospective, multicenter, randomized study enrolled 274 subjects at 36 sites in the United States and Europe. Subjects were randomly assigned in a 3:1 ratio to treatment with the TIGRIS stent (n=197; mean age 66.7±9.28 years; 141 men) or LifeStent (n=70; mean age 67.9±8.87 years; 49 men). The primary safety endpoint was 30-day freedom from major adverse events (MAE). The primary efficacy endpoint was primary patency at 12 months. Secondary endpoints included target lesion revascularization (TLR) and stent fracture. Clinical success and quality of life were also assessed.. Mean lesion length (107.6 vs 117.9 mm, p=0.29), procedure success (99.5% vs 97.1%, p=0.17), and freedom from MAE (99.5% vs 100%, p>0.99) were similar for the TIGRIS and control groups, respectively. Likewise, there was no difference in primary patency at 12 months (60.6% vs 63.2%, p=0.73) or 24 months (56.3% vs 50.2%, p=0.60) or in TLR at the same time points (76.6% vs 80.6%, p=0.49; 70.5% vs 67.2%, p=0.85). There were no differences in the changes in Rutherford category or the ankle/brachial index through 24 months. The rate of stent fracture was lower for TIGRIS compared with LifeStent (0% vs 32.7%, p<0.001).. The TIGRIS stent and LifeStent were similarly effective for the treatment of lesions in the SFA and PPA. The high flexibility and zero fracture rate associated with the TIGRIS stent make this device favorable for use in high-flexion arteries.

Topics: Aged; Alloys; Endovascular Procedures; Europe; Female; Femoral Artery; Humans; Male; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Prospective Studies; Prosthesis Design; Prosthesis Failure; Self Expandable Metallic Stents; Time Factors; Treatment Outcome; United States; Vascular Patency

To investigate the efficacy of the paclitaxel-coated, self-expanding, nitinol Stentys Stent System in tibioperoneal lesions ≤50 mm long.. The prospective, single-arm, multicenter PES-BTK-70 trial ( ClinicalTrials.gov identifier NCT01630070) evaluated the safety and efficacy of the coronary Stentys Stent System in the treatment of a stenotic or occlusive lesion ≤50 mm long in the tibioperoneal arteries of patients with critical limb ischemia (CLI). Between January 2012 and May 2013, 70 patients (mean age 74.6±9.4 years; 45 men) with CLI [Rutherford category 4 (37, 52.9%) or 5 (33, 47.1%)] received a Stentys drug-eluting stent for the treatment of infrapopliteal stenosis (60, 85.7%) or occlusion (10, 14.3%). The mean lesion length was 17.2 mm (4.0-58.5). The primary outcome measures were primary patency at 6 months (duplex ultrasound) and 12 months (angiography). Secondary outcomes included limb salvage and freedom from target lesion revascularization (TLR). Kaplan-Meier estimates of the outcomes are given with the 95% confidence intervals (CI).. Technical and procedure success (<30% residual stenosis without major complications) was achieved in 68 (97.1%) of 70 cases. Primary patency was 87.6% (95% CI 83.5% to 91.7%) at 6 months and 72.6% (95% CI 66.9% to 78.3%) at 1 year. Freedom from TLR was 79.1% at 1 year (95% CI 73.9% to 84.3) and limb salvage was 98.5% (95% CI 97.0 to 100.0). No stent fractures were found by core laboratory review of all follow-up imaging data available up to 12 months.. In this study, the self-expanding, nitinol, paclitaxel-eluting, coronary Stentys stent was found to be safe and effective in the below-the-knee region, with results similar to the most recent limus-eluting stent trials.

Topics: Aged; Aged, 80 and over; Alloys; Angiography; Belgium; Cardiovascular Agents; Constriction, Pathologic; Critical Illness; Drug-Eluting Stents; Endovascular Procedures; Female; Humans; Ischemia; Kaplan-Meier Estimate; Limb Salvage; Male; Middle Aged; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Prospective Studies; Prosthesis Design; Risk Factors; Self Expandable Metallic Stents; Time Factors; Treatment Outcome; Vascular Patency

To report a randomized trial comparing the Legflow paclitaxel-eluting balloon (PEB) + Supera stenting to Supera stenting alone in patients with intermediate to long superficial femoral artery (SFA) lesions.. The multicenter RAPID trial ( controlled-trials.com ; identifier ISRCTN47846578) randomized (1:1) 160 patients (mean age 67 years; 102 men) with Rutherford category 2-6 ischemia to treatment with Legflow PEB + Supera stent or Supera stent alone in intermediate to long SFA lesions (mean lesion length 15.8±7.4 vs 15.8±7.6 cm, respectively). The efficacy outcome was primary patency, defined as freedom from restenosis on duplex ultrasound or angiography.. Baseline characteristics including the percentage of occlusions were similar between groups. In the intention-to-treat analysis, the estimated primary patency at 1 year was 68.3% (95% CI 56.7% to 79.9%) in the PEB + Supera group vs 62.0% (95% CI 49.1% to 74.9%) in the Supera group (p=0.900). Per-protocol analysis showed a 12-month primary patency estimate of 74.7% (95% CI 63.1% to 86.3%) in the PEB + Supera group vs 62.0% (95% CI 49.1% to 74.9%) in the control group (p=0.273). Secondary patency estimates at 12 months (per-protocol analysis) were 89.0% (95% CI 80.6% to 97.4%) vs 98.0% (95% CI 94.1% to 100%; p=0.484); the estimates for freedom from clinically driven target lesion revascularization (CD-TLR) were 83.0% (95% CI 72.8% to 93.2%) and 77.8% (95% CI 66.6% to 89.0%; p=0.277), respectively.. The short-term results from the multicenter RAPID randomized controlled trial indicate that the Legflow PEB is safe and feasible for the treatment of intermediate to long SFA lesions. In this trial, at least 70% of the patients suffered an occlusion. The PEB group had higher rates of primary patency and freedom from CD-TLR, although there were no statistically significant differences vs controls.

Topics: Aged; Alloys; Angiography; Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Equipment Design; Female; Femoral Artery; Germany; Humans; Male; Middle Aged; Netherlands; Paclitaxel; Peripheral Arterial Disease; Prospective Studies; Self Expandable Metallic Stents; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Duplex; Vascular Access Devices; Vascular Patency

Self-expanding nitinol stents must be oversized at least by a minimal amount to ensure contact with the vessel wall and prevent migration. Once the stent is deployed it exerts a continuous force upon the vascular wall, termed chronic outward force (COF). Animal studies have found an increased neointimal hyperplasia in stents with high oversizing and thus high COF. Data about correlation between COF and neointimal hyperplasia in humans are currently lacking. The objective of the BIOFLEX-COF trial is to prospectively investigate differences in formation of intimal hyperplasia at 1 and 2 years after implantation of nitinol stents with high versus low COF in de novo femoropopliteal occlusive arterial lesions.. The BIOFLEX-COF trial is a prospective, quantitative, randomized study. Eighty subjects with symptomatic peripheral arterial lesions eligible for endovascular stent implantation will be enrolled and randomly assigned to either a high COF group (LifeStent Flexstar, Bard Peripheral Vascular Inc., Tempe, AZ, USA) or low COF group (Pulsar, Biotronik AG, Bülach, Switzerland) using an online randomization program to generate a random 1:1 group allocation (block randomization). After implantation and dilatation, COF at every 2 mm along the stent axis will be calculated from the actual stent diameter versus its nominal diameter. There will be two follow-up evaluations at 12 and 24 months. Primary endpoint is the amount of in-stent neointima at 1 year, assessed by contrast-enhanced CT angiography (CTA). In the control examinations, stent diameter and true lumen diameter will be measured on DICOM images every 2 mm along the stent axis to quantify the relative amount of in-stent restenosis. Secondary objectives are the amount of in-stent neointima at 2 years, device- and procedure-related adverse events and target lesion revascularization (TLR) rate. The scheduled time for recruitment is 2 years. Recruitment is expected to be complete in October 2017.. This trial is the first to prospectively investigate the influence of COF on stent patency. If successful, the results will aid in a more precise selection of stent type and size in a given target vessel. The present study is challenging in that it compares two different self-expanding nitinol stents head-to-head against each other. To optimize the power of this study, traditional binary outcome parameters such as TLR and restenosis at Doppler ultrasound were dropped as primary endpoints. Instead, the amount of neointima inside the stent accessed by CTA was selected as (continuous) outcome parameter.. ClinicalTrials.gov Identifier: NCT03097679 . Date of registration: 14 March 2017 (retrospectively registered).

Topics: Alloys; Austria; Clinical Protocols; Computed Tomography Angiography; Constriction, Pathologic; Endovascular Procedures; Femoral Artery; Humans; Neointima; Peripheral Arterial Disease; Popliteal Artery; Pressure; Prospective Studies; Prosthesis Design; Recurrence; Research Design; Self Expandable Metallic Stents; Time Factors; Treatment Outcome; Vascular Patency

The aim of this study was to evaluate the short and mid-term safety and efficacy of the EPIC™ nitinol vascular stent system for the treatment of lesions located in the superficial femoral artery (SFA).. From October 2010 to June 2012, 83 subjects were enrolled in a prospective, multicenter, non-randomized study designed to demonstrate that the EPIC nitinol vascular stent system for SFA lesions is non-inferior to the published patency rates found in literature. Inclusion criteria were stenosis or occlusion of the SFA or SFA and proximal popliteal artery, with total length from 4 to 11 cm and amenable for treatment with a single stent, in patients with a score from 2 to 5 on Rutherford classification. The primary endpoint was primary patency rate at 12 months as determined by Duplex ultrasound. The secondary endpoints evaluated were: initial arteriographic success, primary patency rate at 6 months, major adverse event rate at one year and technical success. Follow-up with a complete clinical and physical exam, including ABI and Duplex ultrasound was performed at 6 and 12 months.. Most patients (56.6%) were men and the mean age was 68.59 (33.1-99.15) years. 25.3% of the total population had intermittent claudication and 73.5% presented with critical limb ischemia. Most lesions were total occlusions (75.9%) and the mean lesion length was 71.16 mm. Contralateral femoral access was performed in 26.5%cases, and ipsilateral femoral approach was used for the remaining 73.5% patients. Technical and arteriographic success was obtained in all 83 (100.00%) patients. Duplex controlled primary patency rate at 6 and 12 months was 95.8% and 76.1%, respectively. The freedom from target lesion revascularization rate was 98.7% and 92.6% at 6 and 12 months, respectively. No stent fractures were observed in this study. Major adverse event rate at 1 year (clinically driven TLR, major amputation, and all-cause mortality) was 15.7%: two target lesion revascularizations (2.4%), one major amputation (1.2%) and ten deaths not related to the procedure (12%).. In conclusion, this study demonstrates the safety and efficacy of the EPIC™ Nitinol Vascular Stent System for the treatment of SFA lesions.

Topics: Adult; Aged; Aged, 80 and over; Alloys; Angiography; Ankle Brachial Index; Brazil; Disease-Free Survival; Endovascular Procedures; Female; Femoral Artery; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Peripheral Arterial Disease; Prospective Studies; Prosthesis Design; Stents; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Duplex; Vascular Patency

The SuperNOVA trial was designed to evaluate performance of the Innova Vascular Self-Expanding Stent System (Boston Scientific, Marlborough, MA) for treating lesions in the femoropopliteal arteries.. Patients with chronic lower limb peripheral artery disease (Rutherford category 2, 3, or 4) and atherosclerotic lesions in the native superficial femoral and/or proximal popliteal artery (lengths 30-190 mm) were enrolled in this single-arm, multinational study. Major adverse events (MAEs) were defined as all-cause death through 1 month, target limb major amputation, and target lesion revascularization (TLR). Vessel primary patency was defined as core laboratory-adjudicated duplex ultrasonography-derived peak systolic velocity ratio ≤2.4 in the absence of TLR, surgical bypass of the target lesion, or major amputation of the target limb. Primary safety and efficacy endpoints were evaluated at 12 months, with follow-up through 24 months also reported.. SuperNOVA patients (N = 299; mean age 67.4 ± 9.7 years, 74% men, 41% with diabetes) had a mean lesion length of 93.2 mm. The MAE-free rate was 99.7% at 30 days, 85.8% at 12 months, and 77% at 24 months. Kaplan-Meier estimates of primary patency and TLR-free rates were 68.7% and 78.0%, respectively, at 24 months. Clinical improvements were sustained through 2 years, with 80% of patients displaying no or minimal symptoms (Rutherford category 0-1) at 24 months.. In the SuperNOVA study, the Innova Stent System demonstrated an excellent safety profile and acceptable clinical outcomes despite the challenging anatomical characteristics of the lesions. © 2017 Wiley Periodicals, Inc.

Topics: Aged; Alloys; Angioplasty, Balloon; Disease-Free Survival; Europe; Female; Femoral Artery; Humans; Japan; Kaplan-Meier Estimate; Male; Middle Aged; North America; Peripheral Arterial Disease; Popliteal Artery; Prospective Studies; Prosthesis Design; Risk Factors; Self Expandable Metallic Stents; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Duplex; Vascular Patency

This study investigated the effects of gender on the 3-year outcomes of the StuDy for EvalUating EndovasculaR TreAtments of Lesions in the Superficial Femoral Artery and Proximal Popliteal By usIng the Protege EverfLex NitInol STent System II (DURABILITY II) trial.. A total of 287 patients enrolled in the DURABILITY II trial (prospective and nonrandomized trial) were stratified by gender and evaluated for primary, primary assisted, and secondary patency at 3 years. Clinical scores including changes in ankle-brachial index (ABI) and walking impairment questionnaire (WIQ) scores were evaluated.. Overall 190 male and 97 female patients were included for analysis. The 3-year primary, assisted primary, and secondary patency rates for women versus men were 62.5% vs. 58.8%, 68.5% vs. 64.9%, and 72.1% vs. 67.2%, respectively (P < 0.05). Although ABIs at presentation were similar between women versus men (0.64 vs. 0.65, P < 0.05), women had lower ABI scores at 3 years compared with men (0.85 vs. 0.92, P = 0.03). Women versus men had inferior walking distance scores at presentation (13.6 vs. 25.7, P < 0.001), scores were equalized by 2 years (51.6 vs. 60.8, P < 0.05); however, 3-year follow-up demonstrated less durable results for women versus men (37.3 vs. 58.8, P < 0.05). In addition, women had worse WIQ scores for pain, walking speed, and stair climbing. However, the relative change in scores between men and women were comparable, with both groups seeing similar improvements from baseline for these parameters.. Women continue to see clinical improvement after intervention, achieving comparable ABIs and walking distance to men at 2 years. These benefits are diminished at 3-year follow-up with women achieving lower absolute ABI and WIQ parameters compared with men, but improved overall compared with scores at presentation.

Topics: Aged; Aged, 80 and over; Alloys; Ankle Brachial Index; Blood Vessel Prosthesis Implantation; Endovascular Procedures; Female; Femoral Artery; Humans; Male; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Prospective Studies; Quality of Life; Sex Factors; Stents; Surveys and Questionnaires; Time Factors; Treatment Outcome; Vascular Patency; Walking

To report the 12-month results of the MAJESTIC clinical study of the self-expanding Eluvia paclitaxel-eluting stent in the treatment of femoropopliteal lesions.. The prospective, single-arm, multicenter trial (clinicaltrials.gov identifier NCT01820637) enrolled 57 patients (mean age 69±9 years; 47 men) with chronic lower limb ischemia referable to de novo or restenotic lesions in the native superficial femoral and/or proximal popliteal arteries. A third of the patients had diabetes. Mean lesion length was 70.8±28.1 mm, and diameter stenosis was 86.3%±16.2%; 26 (46%) lesions were occluded. Primary patency was defined as duplex ultrasound peak systolic velocity ratio ≤2.5 and the absence of target lesion revascularization (TLR) or bypass. Major adverse events (MAEs) included all-cause death through 1 month and target limb major amputation and TLR through 12 months.. All 57 patients had a single Eluvia stent implanted, employing pre- and postdilation in 93% (53/57) and 95% (54/57) of cases, respectively. Technical success was 97% (55/57; 2 failures due to residual stenosis >30%). At 12 months, primary patency was 96% (49/51) and the MAE rate was 4% (2/53); both MAEs were TLRs. No stent fractures were identified. There were no major amputations. One death occurred 368 days postprocedure, unrelated to the device or procedure. Improvements in the Rutherford category were sustained through 1 year, with 81% (43/53) exhibiting no symptoms (category 0) and 13% (7/53) presenting with mild claudication (category 1). Mean ABI improved from 0.73±0.22 at baseline to 1.02±0.20 at 12 months.. MAJESTIC results showed that patients whose femoropopliteal arteries were treated with the Eluvia drug-eluting stent sustained high patency and low MAE rates through 12 months.

Topics: Aged; Alloys; Ankle Brachial Index; Australia; Blood Flow Velocity; Cardiovascular Agents; Chronic Disease; Constriction, Pathologic; Drug-Eluting Stents; Endovascular Procedures; Europe; Female; Femoral Artery; Humans; Ischemia; Kaplan-Meier Estimate; Limb Salvage; Male; Middle Aged; New Zealand; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Prospective Studies; Prosthesis Design; Regional Blood Flow; Self Expandable Metallic Stents; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Duplex; Vascular Patency

Reintervention in the femoropopliteal artery is frequent and a major driver of cost-effectiveness. High wall shear generated by swirling blood flow is associated with reduced occurrence of atherosclerosis and restenosis. This trial investigated the clinical and hemodynamic outcomes of the BioMimics 3D self-expanding tubular nitinol stent with helical centerline geometry compared with a straight stent in the femoropopliteal artery.. In a prospective, multicenter, randomized controlled trial, 76 patients with symptomatic peripheral arterial disease were randomized 2:1 to receive a helical or a straight stent. An independent core laboratory adjudicated angiographic and ultrasound parameters. The primary safety end point was freedom from a composite of all death, target limb amputation, and target lesion revascularization at 30 days. The primary effectiveness end point was freedom from clinically driven target lesion revascularization at 6 months. Patency was a secondary end point. Subjects were followed up for 2 years from intervention. The primary safety (1-sided P<0.01) and efficacy (1-sided P<0.001) end points for the helical stent were met. The proportion of patients treated with the helical stent who maintained patency at 12 and 24 months was 80% and 72%, respectively, compared with 71% and 55% for the control group. The difference was significant through 24 months (P=0.05). Freedom from clinically driven target lesion revascularization for the helical compared with straight stent was 91% versus 92% at 12 months and 91% versus 76% at 24 months.. Both groups had similar safety outcomes and clinically driven target lesion revascularization to 2 years. However, after placement of a BioMimics 3D helical stent, there was improved patency to 2 years.. URL: http://www.clinicaltrials.gov. Unique identifier: NCT02163863.

Topics: Aged; Alloys; Amputation, Surgical; Disease-Free Survival; Endovascular Procedures; Female; Femoral Artery; Germany; Graft Occlusion, Vascular; Humans; Kaplan-Meier Estimate; Limb Salvage; Male; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Prospective Studies; Prosthesis Design; Recurrence; Risk Factors; Stents; Time Factors; Treatment Outcome; Vascular Patency

The self-expandable COMPLETE™ stent (Medtronic) has greater elasticity, allowing it to regain its shape after the compression force reduces, and has higher trackability, thus is easier to maneuver through tortuous vessels, whereas the balloon-expandable SCUBA™ stent (Medtronic) has higher radial stiffness and can afford more accurate placement without geographic miss, which is important in aortoiliac bifurcation lesions. To date, there have been no randomized control trials comparing efficacy and safety between the self-expanding stent and balloon-expandable stent in advanced atherosclerotic iliac artery disease.. The purpose of our study is to examine primary patency (efficacy) and incidence of stent fracture and geographic miss (safety) between two different major representative stents, the self-expanding nitinol stent (COMPLETE-SE™) and the balloon-expanding cobalt-chromium stent (SCUBA™), in stenotic or occlusive iliac arterial lesions. This trial is designed as a prospective, randomized, multicenter trial to demonstrate a noninferiority of SCUBA™ stent to COMPLETE-SE™ stent following balloon angioplasty in iliac arterial lesions, and a total of 280 patients will be enrolled. The primary end point of this study is the rate of primary patency in the treated segment at 12 months after intervention as determined by catheter angiography, computed tomography angiography, or duplex ultrasound.. The SENS-ILIAC trial will give powerful insight into whether the stent choice according to deployment mechanics would impact stent patency, geographic miss, or stent fracture in patients undergoing stent implantation in iliac artery lesions.. National Institutes of Health Clinical Trials Registry (ClinicalTrials.gov identifier: NCT01834495 ), registration date: May 8, 2012.

Topics: Alloys; Angioplasty, Balloon; Chromium Alloys; Clinical Protocols; Constriction, Pathologic; Elasticity; Humans; Iliac Artery; Peripheral Arterial Disease; Prospective Studies; Prosthesis Design; Prosthesis Failure; Republic of Korea; Research Design; Self Expandable Metallic Stents; Stents; Time Factors; Treatment Outcome; Vascular Patency

To assess safety and efficacy of the S.M.A.R.T. Vascular Stent System (Cordis Corp, Fremont, California) in obstructive superficial femoral artery (SFA) disease.. The single-arm, multicenter STROLL study (S.M.A.R.T. Nitinol Self-Expanding Stent in the Treatment of Obstructive Superficial Femoral Artery Disease) included 250 patients (250 lesions in SFA or proximal popliteal artery). The efficacy endpoint was primary patency defined by freedom from binary restenosis (peak systolic velocity ratio > 2.5) as derived by duplex ultrasound plus clinically driven target lesion revascularization (TLR) at 12 months.. Mean age of patients was 67.7 years ± 10.3; 47.2% of patients had diabetes; distribution of Rutherford/Becker classes 2, 3, and 4 was 45.8%, 51.4%, and 2.8%. Mean lesion length and reference vessel diameter were 77.3 mm ± 35.3 and 4.9 mm ± 0.7, respectively (23.6% cases with total occlusions). The 30-day freedom from major adverse events (death, index limb amputation, clinically driven TLR) was 100%. The 1-year primary patency was 81.7% by Kaplan-Meier estimate. The presence of diabetes or total occlusion had no effect on primary patency. Ankle-brachial index was 0.4-0.8 in 84.6% of patients at baseline and improved to > 0.8 in 81.0% of patients at 12 months. The proportion of patients in Rutherford/Becker class 3-4 was reduced from 54.2% at baseline to 8.0% at 12 months. Four patients (2.0%) experienced single-stent strut fracture (type I) at 1 year, without associated loss of stent patency.. The S.M.A.R.T. Vascular Stent System proved to be safe and effective for endovascular treatment of obstructive SFA and proximal popliteal artery disease, based on 1-year vessel patency and associated hemodynamic and clinical improvements.

Topics: Aged; Alloys; Atherosclerosis; Constriction, Pathologic; Female; Femoral Artery; Follow-Up Studies; Humans; Male; Peripheral Arterial Disease; Stents; Treatment Outcome; Ultrasonography, Interventional

The purpose of this study was to evaluate the safety and efficacy of excimer laser atherectomy (ELA) with adjunctive percutaneous transluminal angioplasty (PTA) versus PTA alone for treating patients with chronic peripheral artery disease with femoropopliteal bare nitinol in-stent restenosis (ISR).. Femoropopliteal stenting has shown superiority to PTA for lifestyle-limiting claudication and critical limb ischemia, although treating post-stenting artery reobstruction, or ISR, remains challenging.. The multicenter, prospective, randomized, controlled EXCITE ISR (EXCImer Laser Randomized Controlled Study for Treatment of FemoropopliTEal In-Stent Restenosis) trial was conducted across 40 U.S. centers. Patients with Rutherford Class 1 to 4 and lesions of target lesion length ≥4 cm, vessel diameter 5 to 7 mm were enrolled and randomly divided into ELA + PTA and PTA groups by a 2:1 ratio. The primary efficacy endpoint was target lesion revascularization (TLR) at 6-month follow up. The primary safety endpoint was major adverse event (death, amputation, or TLR) at 30 days post-procedure.. Study enrollment was stopped at 250 patients due to early efficacy demonstrated at a prospectively-specified interim analysis. A total of 169 ELA + PTA subjects (62.7% male; mean age 68.5 ± 9.8 years) and 81 PTA patients (61.7% male; mean age 67.8 ± 10.3 years) were enrolled. Mean lesion length was 19.6 ± 12.0 cm versus 19.3 ± 11.9 cm, and 30.5% versus 36.8% of patients exhibited total occlusion. ELA + PTA subjects demonstrated superior procedural success (93.5% vs. 82.7%; p = 0.01) with significantly fewer procedural complications. ELA + PTA and PTA subject 6-month freedom from TLR was 73.5% versus 51.8% (p < 0.005), and 30-day major adverse event rates were 5.8% versus 20.5% (p < 0.001), respectively. ELA + PTA was associated with a 52% reduction in TLR (hazard ratio: 0.48; 95% confidence interval: 0.31 to 0.74).. The EXCITE ISR trial is the first large, prospective, randomized study to demonstrate superiority of ELA + PTA versus PTA alone for treating femoropopliteal ISR. (Randomized Study of Laser and Balloon Angioplasty Versus Balloon Angioplasty to Treat Peripheral In-stent Restenosis [EXCITE ISR]; NCT01330628).

Topics: Aged; Alloys; Amputation, Surgical; Angioplasty, Balloon; Atherectomy; Chronic Disease; Combined Modality Therapy; Constriction, Pathologic; Female; Femoral Artery; Humans; Laser Therapy; Lasers, Excimer; Limb Salvage; Male; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Prospective Studies; Prosthesis Design; Recurrence; Stents; Time Factors; Treatment Outcome; United States; Vascular Patency

To investigate the 2-year technical and clinical results of primary nitinol stent placement in comparison with percutaneous transluminal angioplasty (PTA) in the treatment of de novo lesions of the popliteal artery.. The ETAP study (Endovascular Treatment of Atherosclerotic Popliteal Artery Lesions: balloon angioplasty vs. primary stenting; www.ClinicalTrials.gov identifier NCT00712309) is a prospective, randomized trial that enrolled 246 patients (158 men; mean age 72 years) who were randomly assigned to receive a nitinol stent (n=119) or PTA (n=127) for lesions averaging 42.3 mm in length. The results of the primary study endpoint were published. Secondary outcome measures and endpoints included primary patency (freedom from duplex-detected target lesion restenosis), target lesion revascularization (TLR), secondary patency, changes in ankle-brachial index and Rutherford class, and event-free survival (freedom from target limb amputation, TLR, myocardial infarction, and death).. In total, 183 patients (89 stent and 94 PTA) were available for the 2-year analysis. The primary patency rate was significantly higher in the stent group (64.2%) than in the PTA group (31.3%, p=0.0001). TLR rates were 22.4% and 59.5%, respectively (p=0.0001). When provisional stent placement in the PTA arm was not considered as TLR and loss in patency, the differences prevailed between the study groups but were not significant (64.2% vs. 56.1% for primary patency, respectively; p=0.44). A significant improvement in ABI and Rutherford category was observed at 2 years in both groups.. In treatment of obstructive popliteal artery lesions, provisional stenting reveals equivalent patency in comparison to primary stenting. However, the 2-year results of this trial suggest the possibility of a shift toward higher patency rates in favor of primary stenting.

Topics: Adult; Aged; Aged, 80 and over; Alloys; Angioplasty, Balloon; Ankle Brachial Index; Austria; Female; Follow-Up Studies; Germany; Humans; Male; Middle Aged; Patient Selection; Peripheral Arterial Disease; Popliteal Artery; Prospective Studies; Stents; Switzerland; Time Factors; Treatment Outcome; Vascular Patency

Stent-based therapy in the superficial femoral and popliteal arteries in patients with peripheral artery disease is compromised by restenosis and risk of stent fracture or distortion. A novel self-expanding nitinol stent was developed that incorporates an interwoven-wire design (Supera stent, IDEV Technologies, Inc, Webster, TX) to confer greater radial strength, flexibility, and fracture resistance.. This prospective, multicenter, investigational device exemption, single-arm trial enrolled 264 patients with symptomatic peripheral artery disease undergoing percutaneous treatment of de novo or restenotic lesions of the superficial femoral or proximal popliteal (femoropopliteal) artery. Freedom from death, target lesion revascularization, or any amputation of the index limb at 30 days (+ 7 days) postprocedure was achieved in 99.2% (258/260) of patients (P < 0.001). Primary patency at 12 months (360 ± 30 days) was achieved in 78.9% (180/228) of the population (P < 0.001). Primary patency by Kaplan-Meier analysis at 12 months (360 days) was 86.3%. No stent fracture was observed by independent core laboratory analysis in the 243 stents (228 patients) evaluated at 12 months. Clinical assessment at 12 months demonstrated improvement by at least 1 Rutherford-Becker category in 88.7% of patients.. The SUPERB Trial, an investigational device exemption study using an interwoven nitinol wire stent in the femoropopliteal artery, achieved the efficacy and safety performance goals predesignated by the Food and Drug Administration. On the basis of the high primary patency rate, absence of stent fracture, and significant improvements in functional and quality-of-life measures, the Supera stent provides safe and effective treatment of femoropopliteal lesions in symptomatic patients with peripheral artery disease.. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00933270.

Topics: Aged; Alloys; Endovascular Procedures; Female; Femoral Artery; Humans; Male; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Prospective Studies; Quality of Life; Stents; Treatment Outcome; Vascular Patency

To compare primary placement of a self-expanding nitinol stent to percutaneous transluminal angioplasty (PTA) with bailout stenting in infrapopliteal arteries of patients with severe intermittent claudication or critical limb ischemia (CLI).. In the EXPAND trial (ClinicalTrials.gov; identifier NCT00906022), 92 patients (mean age 72.9±9.5 years; 62 men) undergoing treatment for infrapopliteal stenosis in 11 European centers were randomized 1:1 to either self-expanding nitinol stenting with the Astron Pulsar/Pulsar-18 nitinol stent or PTA with bailout stenting. The primary endpoint was sustainable clinical improvement after 12 months, defined as a ≥1-category increase for Rutherford category 3 patients or a ≥2-category increase for CLI patients (Rutherford categories 4/5) compared with baseline. Furthermore, target lesion revascularization (TLR), mortality, and amputation were assessed after 12 months.. Sustained clinical improvement at 1 year was observed in 74.3% of the patients treated with primary stenting and in 68.6% of the patients treated with PTA and bailout stenting (p>0.05). Kaplan-Meier estimates of freedom from TLR (76.6% and 77.6%), mortality (7.4% vs 2.1%), and amputation [8.9% (major 6.7%) vs 13.2% (major 8.7%)] at 1 year were not significantly different.. Primary self-expanding nitinol stenting did not show statistically different clinical outcomes compared to angioplasty with bailout stenting for infrapopliteal lesions.

Topics: Aged; Aged, 80 and over; Alloys; Amputation, Surgical; Angioplasty, Balloon; Critical Illness; Disease Progression; Disease-Free Survival; Endovascular Procedures; Europe; Female; Humans; Intermittent Claudication; Ischemia; Kaplan-Meier Estimate; Limb Salvage; Male; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Prospective Studies; Prosthesis Design; Recurrence; Risk Assessment; Risk Factors; Stents; Time Factors; Treatment Outcome; Vascular Patency

To report the 1-year results of a pivotal study for a new-generation nitinol stent for the treatment of iliac atherosclerotic lesions.. The ORION trial (ClinicalTrials.gov identifier NCT00896337) was a single-arm, non-randomized, prospective, multicenter clinical trial that enrolled 125 patients (81 men; mean age 61.1±9.3 years) implanted with the EPIC self-expanding nitinol stent system in 166 de novo or restenotic iliac artery lesions ≤13 cm long. The primary endpoint was the 9-month major adverse event rate [i.e., device- or procedure-related death within 30 days, myocardial infarction during the index hospitalization, target vessel revascularization (TVR), or index limb amputation]. Follow-up occurred at hospital discharge and at 1, 9, and 12 months. An independent core laboratory evaluated ultrasound results at 1, 9, and 12 months.. The primary endpoint met the prespecified performance goal, with only 3.4% (4/117) of patients experiencing a major adverse event by 9 months (p<0.0001). By 12 months, 6 (5.4%) of 111 patients had TVR; none had an index limb amputation. The ankle-brachial index, Walking Impairment Questionnaire, and Rutherford classifications all showed sustained improvements through 12 months. Primary patency was 94.4% with comparable results for lesions classified as complex (TASC II C/D 95.5%) or non-complex (TASC II A/B 95.0%).. The EPIC stent system demonstrated safety and effectiveness through 12 months, including improvements for complex lesions. The EPIC stent is a viable alternative to surgery for patients with either complex or non-complex lesions.

Topics: Aged; Alloys; Ankle Brachial Index; Constriction, Pathologic; Disability Evaluation; Endovascular Procedures; Female; Humans; Iliac Artery; Male; Middle Aged; Peripheral Arterial Disease; Prospective Studies; Prosthesis Design; Stents; Surveys and Questionnaires; Time Factors; Treatment Outcome; Ultrasonography, Interventional; United States; Vascular Patency

To determine the safety and efficacy of a new-generation nitinol stent with enhanced flexibility in arterial lesions in the superficial femoral artery (SFA) and proximal popliteal artery (PPA).. The Complete Self-Expanding (SE) Multicenter Trial (ClinicalTrials.gov identifier NCT00814970) enrolled 196 patients (124 men; mean age 68.7±10.5 years) from 28 centers in the United States and Europe. The patients presented with intermittent claudication (193/196) or ischemic rest pain (3/196) and were treated with nitinol stents for obstructive lesions of the SFA or PPA. Over a quarter of lesions (29.9%) were chronic total occlusions. The mean lesion length was 60.7 mm. Moderate to severe calcification was present in 91.0% of lesions.. A total of 225 stents were successfully implanted in 213 (99.5%) of 214 lesions. Acute lesion success (<30% residual stenosis) was achieved in 90.0%. There were no in-hospital major adverse events. Primary patency (defined as a peak systolic velocity ratio <2.0) at 12 months was 72.6%. Clinically-driven target lesion revascularization (TLR) was required in 8.4% of patients at 12 months. The mean ankle-brachial index increased from 0.7 at baseline to 0.9, and there was sustained improvement in the Rutherford category, with 83% of patients classified as Rutherford category 0 or 1 at 12-month follow-up. No stent fractures were detected through 12 months.. In this multicenter trial, primary implantation of a new-generation self-expanding nitinol stent in the SFA and PPA was associated with a low rate of TLR and sustained clinical benefit at 12 months without stent fracture.

Topics: Aged; Alloys; Angioplasty, Balloon; Ankle Brachial Index; Blood Flow Velocity; Chronic Disease; Europe; Female; Femoral Artery; Humans; Intermittent Claudication; Ischemia; Male; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Prospective Studies; Prosthesis Design; Radiography; Recovery of Function; Stents; Time Factors; Treatment Outcome; United States; Vascular Calcification; Vascular Patency

There have been few randomized control trials comparing the incidence of stent fracture and primary patency among different self-expanding nitinol stents to date. The SMART™ CONTROL stent (Cordis Corp, Miami Lakes, Florida, United States) has a peak-to-valley bridge and inline interconnection, whereas the COMPLETE™-SE stent (Medtronic Vascular, Santa Rosa, California, United States) crowns have been configured to minimize crown-to-crown interaction, increasing the stent's flexibility without compromising radial strength. Further, the 2011 ESC (European society of cardiology) guidelines recommend that dual antiplatelet therapy with aspirin and a thienopyridine such as clopidogrel should be administered for at least one month after infrainguinal bare metal stent implantation. Cilostazol has been reported to reduce intimal hyperplasia and subsequent repeat revascularization. To date, there has been no randomized study comparing the safety and efficacy of two different antiplatelet regimens, clopidogrel and cilostazol, following successful femoropopliteal stenting.. The primary purpose of our study is to examine the incidence of stent fracture and primary patency between two different major representative self-expanding nitinol stents (SMART™ CONTROL versus COMPLETE™-SE) in stenotic or occlusive femoropopliteal arterial lesion. The secondary purpose is to examine whether there is any difference in efficacy and safety between aspirin plus clopidogrel versus aspirin plus cilostazol for one month following stent implantation in femoropopliteal lesions. This is a prospective, randomized, multicenter trial to assess the efficacy of the COMPLETE™-SE versus SMART™ CONTROL stent for provisional stenting after balloon angioplasty in femoropopliteal arterial lesions. The study design is a 2x2 randomization design and a total of 346 patients will be enrolled. The primary endpoint of this study is the rate of binary restenosis in the treated segment at 12 months after intervention as determined by catheter angiography or duplex ultrasound.. This trial will provide powerful insight into whether the design of the COMPLETE™-SE stent is more fracture-resistant or effective in preventing restenosis compared with the SMART™ CONTROL stent. Also, it will determine the efficacy and safety of aspirin plus clopidogrel versus aspirin plus cilostazol in patients undergoing stent implantation in femoropopliteal lesions.. Registered on 2 April 2012 with the National Institutes of Health Clinical Trials Registry (ClinicalTrials.gov identifier# NCT01570803).

Topics: Alloys; Angioplasty, Balloon; Aspirin; Cilostazol; Clinical Protocols; Clopidogrel; Drug Therapy, Combination; Femoral Artery; Humans; Peripheral Arterial Disease; Platelet Aggregation Inhibitors; Popliteal Artery; Prospective Studies; Prosthesis Design; Prosthesis Failure; Research Design; Stents; Tetrazoles; Ticlopidine; Time Factors; Treatment Outcome; Vascular Patency

This study sought to evaluate the outcomes of drug-eluting stent treatment for femoropopliteal in-stent restenosis (ISR).. ISR after femoropopliteal interventions is an increasing problem. Although the role of drug-eluting stents in the treatment of coronary ISR is well defined, no published studies have examined drug-eluting stents in the treatment of femoropopliteal ISR.. This study examines 108 patients with 119 ISR lesions who were enrolled in the ZILVER-PTX single-arm study, a prospective, multicenter clinical trial of 787 patients. All patients were treated with paclitaxel-eluting nitinol stents.. Mean patient age was 68.3 ± 9.4 years; 61.1% of patients were men. Mean lesion length was 133.0 ± 91.7 mm; 33.6% of lesions were >150 mm long and 31.1% of lesions were totally occluded. Procedural success was achieved in 98.2% of lesions with 2.1 ± 1.2 stents placed per lesion. Primary patency was 95.7% at 6 months and 78.8% at 1 year. Freedom from target lesion revascularization was 96.2% at 6 months, 81.0% at 1 year, and 60.8% at 2 years. Forty patients experienced major adverse events, exclusively target lesion revascularization. Before treatment, 81.1% of patients had Rutherford scores ≥3; at 2 years, 60.9% of patients had Rutherford scores ≤1. Both ankle brachial index and walking impairment questionnaire scores significantly improved following treatment. The 1-year fracture rate of stents used in ISR lesions was 1.2%. No significant risk factors associated with loss of patency were identified.. Treatment of femoropopliteal ISR with paclitaxel-eluting stents results in favorable acute, midterm, and long-term outcomes. (Zilver PTX Global Registry [ZILVER-PTX]; NCT01094678).

Topics: Aged; Alloys; Angioplasty, Balloon; Ankle Brachial Index; Canada; Cardiovascular Agents; Constriction, Pathologic; Disease-Free Survival; Drug-Eluting Stents; Europe; Exercise Test; Female; Femoral Artery; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Multivariate Analysis; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Prospective Studies; Prosthesis Design; Prosthesis Failure; Recurrence; Registries; Republic of Korea; Risk Factors; Surveys and Questionnaires; Time Factors; Treatment Outcome; Vascular Patency

The BRAVISSIMO study is a prospective, non-randomized, multi-center, multi-national, monitored trial, conducted at 12 hospitals in Belgium and 11 hospitals in Italy. This manuscript reports the findings up to the 12-month follow-up time point for both the TASC A&B cohort and the TASC C&D cohort. The primary endpoint of the study is primary patency at 12 months, defined as a target lesion without a hemodynamically significant stenosis on Duplex ultrasound (>50%, systolic velocity ratio no greater than 2.0) and without target lesion revascularization (TLR) within 12 months. Between July 2009 and September 2010, 190 patients with TASC A or TASC B aortoiliac lesions and 135 patients with TASC C or TASC D aortoiliac lesions were included. The demographic data were comparable for the TASC A/B cohort and the TASC C/D cohort. The number of claudicants was significantly higher in the TASC A/B cohort, The TASC C/D cohort contains more CLI patients. The primary patency rate for the total patient population was 93.1%. The primary patency rates at 12 months for the TASC A, B, C and D lesions were 94.0%, 96.5%, 91.3% and 90.2% respectively. No statistical significant difference was shown when comparing these groups. Our findings confirm that endovascular therapy, and more specifically primary stenting, is the preferred treatment for patients with TASC A, B, C and D aortoiliac lesions. We notice similar endovascular results compared to surgery, however without the invasive character of surgery.

Topics: Adult; Aged; Aged, 80 and over; Alloys; Female; Humans; Iliac Artery; Male; Middle Aged; Peripheral Arterial Disease; Recurrence; Stents

Angioplasty and stenting are options for revascularization of symptomatic femoral popliteal disease. Although angioplasty alone is effective in short lesions, longer lesions are often treated with stents. Multiple overlapping stents are expensive and may be associated with stent fracture. This trial evaluated the safety and efficacy of a single self-expanding stent up to 20 cm in length in patients with atherosclerotic disease of the superficial femoral artery (SFA) and proximal popliteal artery.. Patients with lesions >4 cm and <18 cm were enrolled in this nonrandomized, prospective, multicenter trial that evaluated the Protégé EverFlex Self-Expanding Peripheral Stent System (Covidien, Plymouth, Minn). The study's primary end points were the 30-day major adverse event rate and duplex ultrasound-assessed patency at 1 year. These were compared with published performance goals. A preplanned analysis was conducted for the primary effectiveness end points at 1 year. Follow-up, including history, ankle-brachial index, patient-reported outcomes, duplex ultrasound assessment, and radiographs, is planned through 3 years. There was core laboratory review of angiograms, ultrasound scans, and plain radiographs. A subgroup of patients was studied with graded treadmill testing.. The study enrolled 287 patients (66% male; mean age, 68 years) with stenotic, restenotic, or occluded lesions of the SFA at 44 investigational sites in the United States and Europe. Systemic comorbidities included hypertension (88%), hyperlipidemia (86%), diabetes (43%), and prior SFA intervention (41%). The mean lesion length measured by the core laboratory was 89 mm. The mean normal-to-normal lesion length measured by sites was 110 mm. A total of 303 stents were implanted, and 95% of patients received a single stent. No major adverse events occurred at 30 days. At 1 year, primary outcome of duplex ultrasound stent patency was 67.7% in evaluable patients, and among 1-year secondary outcomes, the mean ankle-brachial index increased by 0.25. Walking Improvement Questionnaire scores improved in pain by 33.7, distance by 37.1, speed by 18.6, and stair climbing by 24.7. The Kaplan-Meier estimate of primary patency was 77.2%, primary assisted patency was 86.9%, and secondary patency was 87.3%. Rutherford clinical category improved in 83.5% of patients. Stent fracture rate was 0.4%. Matched absolute claudication distance was 412 feet greater and was not statistically different in this subgroup of 29 individuals.. The results of DURABILITY II (StuDy for EvalUating EndovasculaR TreAtments of Lesions in the Superficial Femoral Artery and Proximal Popliteal By usIng the Protégé EverfLex NitInol Stent SYstem II) suggest that a new single stent strategy is safe and effective for the treatment of long lesions of the SFA and proximal popliteal arteries at 1 year.

Topics: Adult; Aged; Aged, 80 and over; Alloys; Angioplasty, Balloon; Ankle Brachial Index; Chi-Square Distribution; Constriction, Pathologic; Disease-Free Survival; Europe; Exercise Test; Exercise Tolerance; Female; Femoral Artery; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Stents; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Duplex; United States; Vascular Patency

It remains unclear whether cilostazol, which has been shown to improve the clinical outcomes of endovascular therapy for femoropopliteal lesions, also reduces angiographic restenosis.. The Sufficient Treatment of Peripheral Intervention by Cilostazol (STOP-IC) study investigated whether cilostazol reduces the 12-month angiographic restenosis rate after percutaneous transluminal angioplasty with provisional nitinol stenting for femoropopliteal lesions. Two hundred patients with femoropopliteal lesions treated from March 2009 to April 2011 at 13 cardiovascular centers were randomly assigned 1:1 to receive oral aspirin with or without cilostazol. The primary end point was 12-month angiographic restenosis rate. Secondary end points were the restenosis rate on duplex ultrasound, the rate of major adverse cardiac events, and target lesion event-free survival. Researchers evaluated all follow-up data and assessed the end points in a blinded fashion. The mean lesion length and reference vessel diameter at the treated segment were 128±86 mm and 5.4±1.4 mm, respectively. The frequency of stent used was similar between groups (88% versus 90% in the cilostazol and noncilostazol group, respectively, P=0.82). During the 12-month follow-up period, 11 patients died and 152 patients (80%) had evaluable angiographic data at 12 months. The angiographic restenosis rate at 12 months was 20% (15/75) in the cilostazol group versus 49% (38/77) in the noncilostazol group (P=0.0001) by intention-to-treat analysis. The cilostazol group also had a significantly higher event-free survival at 12 months (83% versus 71%, P=0.02), although cardiovascular event rates were similar in both groups.. Cilostazol reduced angiographic restenosis after percutaneous transluminal angioplasty with provisional nitinol stenting for femoropopliteal lesions.. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00912756; and URL: https://www.umin.ac.jp. Unique identifier: UMIN000002091.

Topics: Aged; Aged, 80 and over; Alloys; Angioplasty; Aspirin; Cardiovascular Diseases; Cilostazol; Constriction, Pathologic; Disease-Free Survival; Drug Therapy, Combination; Female; Femoral Artery; Follow-Up Studies; Humans; Male; Middle Aged; Peripheral Arterial Disease; Platelet Aggregation Inhibitors; Popliteal Artery; Prospective Studies; Radiography; Recurrence; Single-Blind Method; Stents; Tetrazoles; Ultrasonography; Vasodilator Agents

The hypothesis that endovascular treatment with covered stents has equal risks but higher efficacy than bare-metal stents (BMS) in long femoropopliteal artery disease was tested.. Although endovascular treatment of short superficial femoral artery lesions revealed excellent results, efficacy in long lesions remains unsatisfactory.. In a prospective, randomized, single-blind, multicenter study, 141 patients with symptomatic peripheral arterial disease were assigned to treatment with heparin-bonded, covered stents (Viabahn 72 patients) or BMS (69 patients). Clinical outcomes and patency rates were assessed at 1, 6, and 12 months.. Mean ± SD lesion length was 19.0 ± 6.3 cm in the Viabahn group and 17.3 ± 6.6 cm in the BMS group. Major complications within 30 days were observed in 1.4%. The 12-month primary patency rates in the Viabahn and BMS groups were: intention-to-treat (ITT) 70.9% (95% confidence interval [CI]: 0.58 to 0.80) and 55.1% (95% CI: 0.41 to 0.67) (log-rank test p = 0.11); treatment per-protocol (TPP) 78.1% (95% CI: 0.65 to 0.86) and 53.5% (95% CI: 0.39 to 0.65) (hazard ratio: 2.23 [95% CI: 1.14 to 4.34) (log-rank test p = 0.009). In lesions ≥20 cm, (TransAtlantic Inter-Society Consensus class D), the 12-month patency rate was significantly longer in VIA patients in the ITT analysis (VIA 71.3% vs. BMS 36.8%; p = 0.01) and the TPP analysis (VIA 73.3% vs. BMS 33.3%; p = 0.004). Freedom from target lesion revascularization was 84.6% for Viabahn (95% CI: 0.72 to 0.91) versus 77.0% for BMS (95% CI: 0.63 to 0.85; p = 0.37). The ankle-brachial index in the Viabahn group significantly increased to 0.94 ± 0.23 compared with the BMS group (0.85 ± 0.23; p < 0.05) at 12 months.. This randomized trial in symptomatic patients with peripheral arterial disease who underwent endovascular treatment for long femoropopliteal lesions demonstrated significant clinical and patency benefits for heparin-bonded covered stents compared with BMS in lesions ≥20 cm and for all lesions in the TPP analysis. In the ITT analysis for all lesions, which was flawed by major protocol deviations in 8.5% of the patients, the difference was not significant. (GORE VIABAHN® endoprosthesis with bioactive propaten surface versus bare nitinol stent in the treatment of TASC B, C and D lesions in superficial femoral artery occlusive disease; ISRCTN48164244).

Topics: Aged; Alloys; Ankle Brachial Index; Anticoagulants; Coated Materials, Biocompatible; Drug-Eluting Stents; Female; Femoral Artery; Heparin; Humans; Male; Peripheral Arterial Disease; Polytetrafluoroethylene; Popliteal Artery; Proportional Hazards Models; Prospective Studies; Single-Blind Method; Stents; Vascular Patency

This study sought to compare paclitaxel-eluting balloon (PEB) with conventional percutaneous transluminal angioplasty (PTA), followed by systematic implantation of a self-expanding nitinol bare-metal stent (BMS) in patients at risk for restenosis.. PTA is an effective strategy for treating atherosclerosis of the femoropopliteal axis (FPA). Whereas PEB have shown advantage over uncoated balloons in the treatment of simple lesions, it is unknown whether these results are applicable to complex degrees of FPA atheroma.. A total of 104 patients (110 FPA lesions in 110 limbs) were randomly assigned to either PEB + BMS or PTA + BMS. The primary endpoint was 12-month binary restenosis. Secondary endpoints were freedom from target lesion revascularization and major amputation. Post hoc subanalyses were performed for the comparison of long (≥100 mm) versus short lesions and true lumen versus subintimal approach.. Mean lesion length was 94 ± 60 versus 96 ± 69 mm in the PEB + BMS and PTA + BMS groups (p = 0.8), respectively. The primary endpoint occurred in 9 (17%) versus 26 (47.3%) of lesions in the PEB + BMS and PTA + BMS groups (p = 0.008), respectively. A near-significant (p = 0.07) 1-year freedom from target lesion revascularization advantage was observed in the PEB + BMS group. No major amputation occurred. No significant difference was observed according to lesion characteristics or technical approach.. Pre-dilation with PEB angioplasty prior to BMS implantation, as compared to PTA + BMS in complex FPA lesions, reduces restenosis and target lesion revascularization at 12-month follow-up. Restenosis reduction is maintained irrespective of lesion length and recanalization technique. (Drug Eluting Balloon in Peripheral Intervention for the Superficial Femoral Artery [DEBATE-SFA]; NCT01556542).

Topics: Aged; Aged, 80 and over; Alloys; Amputation, Surgical; Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Constriction, Pathologic; Disease-Free Survival; Equipment Design; Female; Femoral Artery; Humans; Italy; Kaplan-Meier Estimate; Limb Salvage; Male; Paclitaxel; Peripheral Arterial Disease; Prospective Studies; Radiography; Recurrence; Risk Factors; Stents; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency

To report the 1-year results of a prospective multicenter trial to evaluate the safety and efficacy of treating symptomatic femoropopliteal occlusive disease using 4-F-compatible materials and no closure device.. The non-randomized 4-EVER trial (4-F endovascular treatment approach to infrainguinal disease) was conducted at 5 European hospitals (ClinicalTrials.gov identifier NCT01413139). The protocol mandated the use of only 4-F sheaths, self-expanding nitinol stents (Astron Pulsar or Pulsar-18 stent), and balloons from a single manufacturer. Between June 2010 and June 2011, 120 symptomatic patients (82 men; mean age 71±9.7 years, range 47-90), primarily claudicants, treated for 120 femoropopliteal lesions (>90% TASC A/B) were enrolled. The mean lesion length was 71.0±45.9 mm. Follow-up evaluations were scheduled on day 1 and at 1, 6, 12, and 24 months. A duplex ultrasound was performed on all follow-up visits to determine vessel patency (primary outcome measure at 1 year), and biplanar radiography was performed at 12 and 24 months to assess stent fracture.. Stents were successfully implanted in all patients: an Astron Pulsar stent in 70 (58.3%) lesions and a Pulsar-18 stent in 46 (38.3%); 4 (3.3%) patients had both stents implanted for flow-limiting dissection after predilation. No closure devices were used; the mean manual compression time was 8.1 minutes (2-15). Four (3.3%) patients developed significant hematoma at the puncture site, but none required surgical repair. The overall 12-month primary patency rate was 81.4%: 85.2% for the Astron Pulsar and 73.4% for the Pulsar-18 (p=0.236). Freedom from target lesion revascularization at 12 months for the entire cohort was 89.3%.. Compared to published historical data for superficial femoral artery type A/B lesion stenting using 6-F devices, the 4-F devices applied in this trial showed similar patency at 12 months, fewer access site complications, and shorter manual compression times, supporting the supposition that 4-F endovascular treatment is safe and effective.

Topics: Aged; Aged, 80 and over; Alloys; Angioplasty, Balloon; Belgium; Equipment Design; Female; Femoral Artery; Germany; Humans; Male; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Prospective Studies; Radiography; Stents; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Duplex; Vascular Access Devices; Vascular Patency

The excellent performance of the Supera Peripheral Stent System. A retrospective analysis was conducted of 136 consecutive limbs from 128 patients with atherosclerotic disease in the femoropopliteal region, treated with Supera stents between September 2010 and September 2017. As primary endpoints patency rates and freedom from target lesion revascularization (TLR) were calculated and presented using Kaplan-Meier analysis.. Fifty-five percent were treated for claudication (IC), 45% for chronical limb threatening ischemia (CLTI). The mean treated lesion length was 143 mm (±77.8). The majority of lesions (63%) were Trans-Atlantic Inter-Society Consensus Criteria II (TASC II) C/D lesions. The overall primary patency rates at 12 and 24 months of follow-up were 72.6% and 60.8% respectively. The primary patency at 12 and 24 months for TASC II A/B lesions was respectively 86% and 75.4%. For TASC II C/D lesions primary patency at 12 and 24 months was 64% and 51.1% respectively (. Endovascular treatment of femoropopliteal disease with Supera Stent is safe, even in extensive, highly calcified lesions. Patency rates and freedom from TLR are acceptable in a real-life population.

Topics: Arterial Occlusive Diseases; Humans; Ischemia; Peripheral Arterial Disease; Popliteal Artery; Prosthesis Design; Retrospective Studies; Stents; Treatment Outcome; Vascular Patency

The Misago iliac stent has not been compared with other stents. This study aimed to evaluate the 2-year clinical outcomes between the Misago stent and other self-expandable nitinol stents for symptomatic chronic aortoiliac disease.. This retrospective, single-center observational study enrolled 138 patients (180 limbs; Rutherford classification, between categories 2 and 6) treated with a Misago stent (N.=41) or self-expandable nitinol stent (N.=97) between January 2019 and December 2019. The primary endpoint was patency for up to 2 years. The secondary endpoints were technical success, procedure-related complications, freedom from target lesion revascularization, overall survival, and freedom from major adverse limb events. Multivariate Cox proportional hazards analysis was used to investigate predictors of restenosis.. The mean follow-up duration was 710±201 days. The 2-year primary patency rate was comparable between the groups (Misago, 89.6% and self-expandable nitinol stent, 91.0%, P=0.883). The technical success rate was 100% in both groups, and procedure-related complications were equivalent between the groups (1.7% and 2.4%, respectively; P=0.773). Freedom from target lesion revascularization was not significantly different between the groups (97.6% and 94.4%, respectively; P=0.890). The overall survival rate and freedom from major adverse limb events were not significantly different between the groups (77.2% and 70.8%, respectively, P=0.209; 66.9% and 58.4%, respectively, P=0.149). Statin therapy was positively associated with primary patency.. The Misago stent for aortoiliac lesions demonstrated comparable and acceptable clinical results of safety and efficacy for up to 2 years compared with other self-expandable stents. Statin use predicted the prevention of patency loss.

Topics: Alloys; Atherosclerosis; Femoral Artery; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Peripheral Arterial Disease; Popliteal Artery; Prosthesis Design; Retrospective Studies; Stents; Time Factors; Treatment Outcome; Vascular Patency

To investigate the 1-year and 2-year clinical outcomes of interwoven stent (IWS) implantation for symptomatic femoropopliteal arterial disease with calcification.. This prospective multicenter study evaluated 308 limbs (63% with the peripheral arterial calcium scoring system 3 and 4 severe calcification and 87% with ≥180° calcification on intravascular ultrasound) of 299 patients (diabetes in 66.9%, chronic renal failure in 52.8%, and dialysis in 49.2%) who underwent IWS (Supera; Abbott, Abbott Park, Illinois) implantation after sufficient predilation (residual stenosis < 30%) for calcified femoropopliteal lesions. The primary outcome measure was primary patency (freedom from restenosis) at 1 and 2 years, whereas the secondary outcome measure included freedom from clinically driven target lesion revascularization (CD-TLR). Clinical parameters associated with loss of patency were explored.. Kaplan-Meier analysis showed that primary patency was 88.2% (95% confidence interval [CI], 84.5%-92.1%) at 1 year and 80.8% (95% CI, 76.1%-85.8%) at 2 years. The CD-TLR-free rate was 96.5% and 94.8% at 1 and 2 years, respectively. The characteristics associated with loss of patency were restenotic lesion with and without stent implantation (adjusted hazard ratio, 1.96 and 2.40; P = .047 and .041, respectively), chronic total occlusion (adjusted hazard ratio, 1.88; P = .022), and popliteal involvement (adjusted hazard ratio, 2.60; P = .002).. The implantation of IWS after sufficient predilation for calcified femoropopliteal atherosclerotic disease demonstrated clinically acceptable primary patency.

Topics: Arctium; Endovascular Procedures; Femoral Artery; Humans; Peripheral Arterial Disease; Popliteal Artery; Prospective Studies; Prosthesis Design; Risk Factors; Stents; Treatment Outcome; Vascular Patency

The aim of this study was to evaluate midterm clinical outcomes after implantation of LifeStent self-expanding nitinol stents for the treatment of femoropopliteal lesions. This retrospective, multicenter, non-randomized study examined 260 femoropopliteal lesions in 250 consecutive patients with peripheral artery disease implanted with LifeStents from April 2016 to April 2017. The prevalence of chronic total occlusion (CTO), lesion length ≥25 cm, and distal reference vessel diameter (RVD) <5 mm was 58%, 35%, and 50%, respectively. The 3-year restenosis rate in the overall population was estimated to be 72.9% and a major adverse limb event was observed in 36.9%. Multivariate analysis revealed that chronic limb-threatening ischemia (CLTI) (odds ratio [OR]: 8.04; 95% confidence interval [CI]: 1.86-34.7), CTO (OR: 4.87; 95% CI: 1.43-16.6), lesion length ≥25 cm (OR: 5.95; 95% CI: 1.11-32.0), and distal RVD <5 mm (OR: 4.43; 95% CI: 1.34-14.6) were independent risk factors for 3-year restenosis. The present study demonstrated the midterm clinical outcomes and risk factors for restenosis after implantation of the LifeStent in femoropopliteal artery lesions. CLTI, CTO, lesion length ≥25 cm, and distal RVD <5 mm predicted decreased patency after a 3-year follow-up.

Topics: Alloys; Femoral Artery; Humans; Peripheral Arterial Disease; Popliteal Artery; Prosthesis Design; Retrospective Studies; Stents; Treatment Outcome; Vascular Patency

We assessed the clinical outcomes of patients with critical limb-threatening ischemia (CLTI) who underwent interwoven nitinol stent (Supera) implantation for significant stenoses of the femoropopliteal segment. In this retrospective cohort study, 116 consecutive patients with CLTI who were treated with Supera stents between September 2015 and March 2020 were included in this analysis. Primary endpoint analysis was completed for amputation-free survival, target lesion revascularization (TLR), and mortality. After a mean follow-up time of 3.4 years, 21 (18%) patients had undergone amputations, 3 (2.6%) died, and, overall, the amputation-free survival rate was 81%. TLR occurred in 21 (18%) patients, resulting in the freedom from target lesion revascularization of 82%. The average Wagner score for all patients was 2.8 ± 1.1. A subgroup analysis of 57 patients revealed a median ulcer size of 3.0 cm

Topics: Alloys; Amputation, Surgical; Chronic Limb-Threatening Ischemia; Follow-Up Studies; Humans; Ischemia; Limb Salvage; Peripheral Arterial Disease; Popliteal Artery; Prosthesis Design; Retrospective Studies; Stents; Treatment Outcome; Vascular Patency

To compare drug-coated balloon (DCB) and bare metal stent (BMS) for primary lesions in femoropopliteal artery disease in Chinese population and to make subgroup analysis between the groups.. Patients with primary lesions who underwent BMS or DCB treatment of a single tertiary vascular center were included and followed up for 24 months. Clinical and anatomic status were reported using the criteria recommended by the Society for Vascular Surgery. The primary endpoint included primary patency, clinically target limb revascularization, composite safety endpoint and all-cause death over 24 months assessed by Kaplan-Meier. Secondary endpoints included technical success rate and stent-related complications.. A total of 284 patients with 324 limbs were pooled into analysis and most of the baseline characteristics did not show significant difference. A total of 74 in BMS group and 71 in DCB group were claudicants while 83 in BMS group and 56 in DCB group suffered from chronic limb threatening ischemia (CLTI). The mean cumulative lesion length was 18.7 ± 9.8cm in BMS group while 17.2 ± 10.3cm in DCB group. Kaplan-Meier estimates of primary patency were 75.3% and 80.9% for BMS and DCB groups at 12 months while decreased to 63.9% and 70.2% at 24 months (log-rank P = 0.167), respectively. Freedom from clinically driven target limb revascularization was 86.8% and 92.7% for BMS and DCB groups at 12 months while dropped to 82.5% and 85.9% at 24 months (log-rank P = 0.342). Estimates of primary patency between BMS and DCB group did not show significant difference on lesions with poor runoff (58.8% vs. 67.3%, log-rank P = 0.127), severe calcification (64.5% vs. 69.4%, log-rank P = 0.525) and popliteal artery involvement (59.3% vs. 60.3%, log-rank P = 0.695) at 24 months. The overall survival (92.6% for BMS, 90.3% for DCB, log-rank P = 0.391) and freedom from composite safety endpoint (79.3% for BMS, 79.2% for DCB, log-rank P = 0.941) showed no significant difference at 24 months.. Over the 24 month follow-up, BMS and DCB showed equivalent efficacy and safety outcomes for primary femoropopliteal artery disease, which indicated the reduction of permanent metallic implant insertion might be possible.

Topics: Alloys; Angioplasty, Balloon; Coated Materials, Biocompatible; Femoral Artery; Humans; Peripheral Arterial Disease; Popliteal Artery; Stents; Treatment Outcome; Vascular Patency

More than 5-year clinical outcomes after femoropopliteal (FP) stenting with bare-nitinol stent (BNS) have not yet been unclear. We investigate the long-term patency and mortality following FP stenting with BNS.. This study was a multicenter retrospective study of a prospectively maintained database. From April 2004 to December 2011, 1824 consecutive patients (2211 limbs) who underwent FP stenting with BNS for de novo lesions were selected and analyzed. Primary endpoint was primary patency which was defined as treated vessel without restenosis and reintervention and its associated factors.. The prevalence of diabetes mellitus and dialysis was 60.5% and 23.8%, respectively. Chronic limb-threatening ischemia (CLTI) accounted for 30.8%. Chronic total occlusion (CTO) was found in 52.7%, and lesion length was more than 20 cm in 22.6%. During the median follow-up of 3.8 years (interquartile range, 1.4 to 7.4 years), 1049 cases lost patency, whereas 355 cases were dead without experiencing loss of patency. The primary patency (95% CI) was estimated to be 74.8%, 47.3% and 29.1% at 1-, 5- and 10-year. On multivariate analysis, female sex, age ≥ 80 years, diabetes, dialysis, CLTI, CTO, arterial calcification, long lesion (＞20 cm), and small vessel (≤ 4 mm) were the independent predictors of primary patency after FP stenting. In addition, the prognostic impact of age ≥ 80 years, CLTI, and arterial calcification was significantly attenuated afterwards (P＜0.05).. Ten-year patency after BNS implantation for FP disease has been continuously reducing up to 10 years and the prognostic impact of risk factors was changed over time.

Topics: Aged, 80 and over; Alloys; Female; Femoral Artery; Follow-Up Studies; Humans; Peripheral Arterial Disease; Popliteal Artery; Prosthesis Design; Retrospective Studies; Risk Factors; Stents; Treatment Outcome; Vascular Patency

To analyze the outcomes of Supera stent deployment in Chinese patients with atherosclerotic femoropopliteal artery (FPA) disease in a real-world setting.. This retrospective cohort study collected and analyzed the medical records of 246 consecutive patients who received Supera stents for FPA disease at the China Academy of Chinese Medical Sciences Xiyuan Hospital between February 2017 and December 2019. All study patients underwent balloon angioplasty and were treated with Supera stents (Abbott Vascular, Santa Clara, CA, USA). The primary outcome was the rate of primary patency 12 months after discharge.. The analyses included 246 consecutive patients and 260 lesions. The mean ± SD age was 73.2 ± 9.9 years and most patients (60.2%) were males. Of the 260 treated lesions, Supera stents were deployed in eight (3.1%) cases after a previous stent fracture. Critical limb ischemia was diagnosed in 87.3% of the limbs, and 84 (32.3%) and 83 (31.5%) cases were classified as TransAtlantic Inter-Society Consensus (TASC) C and D, respectively. Most of the lesions were in situ (80.8%) and located in the superficial femoral artery (45.0%) or the FPA (45.8%). The mean lesion length was 147.7 mm. Nominal deployment (-10 to 10% compression) was the most common deployment scenario (84.1%). The 1-year primary patency rate was 80.6%. Lesions that occurred as restenosis (odds ratio [OR]: = 3.34, 95% confidence interval [CI]: 1.03-10.85, P = 0.045) or in-stent restenosis (OR: = 2.88, 95% CI: 1.03-8.07, P = 0.045) were independently associated with occlusion or stenosis after stent deployment. No stent fracture was observed in this study.. Our study indicates that the use of Supera stents is feasible for the treatment of Chinese patients with FPA disease. The long-term results reveal high primary patency.

Topics: Aged; Aged, 80 and over; Alloys; Atherosclerosis; Constriction, Pathologic; Female; Femoral Artery; Humans; Male; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Prosthesis Design; Retrospective Studies; Risk Factors; Stents; Treatment Outcome; Vascular Patency

Despite being commonly employed to treat peripheral artery disease, self-expanding Nitinol stents are still associated with relatively high incidence of failure in the mid- and long-term due to in-stent restenosis or fatigue fracture. The practice of stent oversizing is necessary to obtain suitable lumen gain and apposition to the vessel wall, though it is regarded as a potential cause of negative clinical outcomes when mis-sizing occurs. The objective of this study was to develop a computational model to provide a better understanding of the structural effects of stent sizing in a patient-specific scenario, considering oversizing ratio OS, defined as the stent nominal diameter to the average vessel diameter, between 1.0 and 1.8. It was found that OS < 1.2 resulted in problematic short-term outcomes, with poor lumen gain and significant strut malapposition. Oversizing ratios that were in the range 1.2 ≤ OS ≤ 1.4 provided the optimum biomechanical performance following implantation, with improved lumen gain, reduced incomplete stent apposition and favourable predicted long-term fatigue performance. Excessive oversizing, OS > 1.4, did not provide any further benefit in outcomes, showing limited increases in lumen gain and unfavourable long-term performance, with higher mean strain values predicted from the fatigue analysis. Therefore, our findings predict that the optimal oversizing ratio for self-expanding Nitinol stents is in the range of 1.2 ≤ OS ≤ 1.4, which is similar to clinical observations, with this study providing detailed insight into the biomechanical basis for this.

Topics: Alloys; Femoral Artery; Humans; Peripheral Arterial Disease; Prosthesis Design; Stents; Treatment Outcome

To compare femoro-popliteal bypass and interwoven nitinol stenting for long occlusions of the femoro-popliteal segment.. Single center retrospective propensity matching analysis of the symptomatic patients with long occlusion of the femoro-popliteal segment (> 20 cm), who underwent stenting with interwoven nitinol stent or femoro-popliteal bypass from 2012 to 2020.. primary patency, primary-assisted patency, secondary patency. Secondary endpoints: major adverse cardiovascular events, major adverse limb events, primary sustained clinical improvement, survival.. A total of 437 patients were enrolled: 294 in the bypass group and 143 in the endovascular therapy (EVT) group. After propensity score matching, 264 and 113 patients remained in the groups, respectively. A median occlusion length was 250 mm. One-year and two-year primary and secondary patency rates were comparable in both groups (two-year primary patency: 68.5% for bypass vs. 68.9% for EVT, p = 1.00). In the "above the knee" subgroup analysis, two-year secondary patency was higher in the EVT group than in the bypass group (90.9% vs. 77.5%, p = 0.048). In "below-the-knee" subgroup analysis, primary and primary assisted patency were statistically significantly higher in the EVT group than in artificial bypass subgroup (66.7% vs. 42.4%, p = .046 and 76.7% vs. 45.5%, p = .011, respectively). However, compared to autovenous bypass, the EVT group showed lower primary patency rates, although the differences are not significant.. A nonselective endovascular strategy can allow for regular successful treatment of femoro-popliteal lesions longer than 25 cm.

Topics: Alloys; Femoral Artery; Humans; Peripheral Arterial Disease; Popliteal Artery; Prosthesis Design; Retrospective Studies; Stents; Treatment Outcome; Vascular Patency

Topics: Alloys; Angioplasty, Balloon; Atherectomy; Coated Materials, Biocompatible; Femoral Artery; Humans; Peripheral Arterial Disease; Popliteal Artery; Retrospective Studies; Stents; Treatment Outcome; Vascular Patency

Approximately 5.8 million people experience peripheral arterial disease (PAD) in the United States today. Superficial femoral artery (SFA) disease is the most common cause of symptomatic PAD. New-generation nitinol stents, drug-coated stents, drug-coated balloons (DCB), covered stents, and directional or orbital atherectomy devices have shown promising results. However, clinical equipoise persists regarding the optimal selection of devices, largely attributable to the different inclusion criteria, study populations, length of lesions treated, definitions of "patency" and "restenosis," and follow-up methods in the up-to-date pivotal trials.. A prospective protocol was developed. We performed a literature search using PubMed from January 2011 to July 2021. All published articles including endovascular interventions in the SFA with reported 12-month "primary patency" rates as endpoints were included.. We identified 25,051 patients in 124 studies reporting 12-month primary patency rates in patients with SFA disease. Primary patency rates were (weighted average) 82.6% for drug-eluting stents, 77.2% for drug-coated balloons, 75.2% for covered stents, 73.9% for nitinol self-expanding stents, 66.1% for atherectomy, and 44.5% for bare balloon angioplasty.. The most frequently used endovascular devices yielded various 12-month primary patency rates ranging from 44.5% to 82.6%. The increased variation in inclusion criteria, lesion length, and complexity of lesions between studies does not allow direct comparison between the individual devices. Larger randomized trials in specific patient populations comparing these modalities are needed well before we can make proper recommendations on the superiority of one device over the other.

Topics: Angioplasty, Balloon; Coated Materials, Biocompatible; Femoral Artery; Humans; Peripheral Arterial Disease; Popliteal Artery; Prospective Studies; Treatment Outcome; Vascular Patency

Stent invagination (SIV) sometimes occurs during interwoven nitinol stent (IWS) placement due to its complex deployment system. It may cause stent malapposition and reduce the minimum stent area. However, the clinical implications of SIV remain unclear. This retrospective single-center study sought to assess the clinical implications of IWS invagination in the femoropopliteal lesions in patients with peripheral arterial diseases. Thirty-two consecutive patients (23 men, mean age of 74 years, 34 limbs) with symptomatic femoropopliteal lesions who had received IWS implantation from January to July 2019 were enrolled. The study was approved by the ethics committee of our institution. The 12-month primary patency rate after the initial IWS placement was evaluated as the primary outcome, which was compared between lesions with SIV (SIV cohort) and without SIV (non-SIV cohort). All IWSs were deployed successfully, but nine cases (26.4%) of SIV occurred during placement. The mean lesion length was 22.3 cm, and critical limb threatening ischemia was observed in 40.6% of the limbs. The overall 12-month primary patency rate was 78.2%. The non-SIV cohort (25 cases) showed a significantly higher primary patency rate than the SIV cohort (9 cases, 91.7% vs. 41.7%, P = 0.0149). IWS implantation showed acceptable durability in Japanese patients in a real-world setting, however, SIV during IWS placement possibly led to a lower 12-month primary patency rate.

Topics: Aged; Alloys; Femoral Artery; Humans; Male; Peripheral Arterial Disease; Popliteal Artery; Prosthesis Design; Retrospective Studies; Risk Factors; Stents; Treatment Outcome; Vascular Patency

Guidelines for the treatment of long femoropopliteal lesions are not based on a high level of evidence and recent randomized controlled trials (RCTs) challenge vein bypass (VBP) as the recommended therapy. This study compared prosthetic (PTFE) bypass, VBP and angioplasty with nitinol stents in long femoropopliteal lesions.. Pooled data from a RCT and a retrospective database with the same inclusion criteria were analyzed with primary and secondary patency as well as freedom from target lesion revascularization (TLR) as primary endpoints.. Between 2016 and 2018 a total of 172 lesions were treated in three groups (PTFE: n = 62, VBP: n = 55, stent: n = 55). Clinical and lesion characteristics were similar with mean lesion lengths between 260 and 279mm. Technical success rate in the stent group was 87%. There were no significant differences between the groups in patency rates, freedom from TLR, limb salvage and survival during 2-year follow-up. The primary patency rates for the PTFE, VBP and stent groups were 50%, 56% and 60% at 2 years. The PTFE group had significantly less complications compared to the other groups and a shorter hospital-stay compared to the VBP group. Clinical improvement was significantly better in the PTFE and VBP group compared to the stent group.. The 2-year results indicate that the role of VBP as the recommended therapy for long femoropopliteal lesions may not be unchallenged due to the similar results in all three groups. Further RCTs are needed to determine the best revascularization modality for long femoropopliteal lesions.

Topics: Aged; Alloys; Angioplasty; Austria; Blood Vessel Prosthesis; Blood Vessel Prosthesis Implantation; Databases, Factual; Female; Femoral Artery; Humans; Male; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Prosthesis Design; Randomized Controlled Trials as Topic; Retrospective Studies; Stents; Time Factors; Treatment Outcome; Vascular Patency; Veins

To report the 3-year results of Innova™ stent implantation for the treatment of femoropopliteal (FP) lesions in a real-world setting.. This single-arm, retrospective, multicenter clinical study analyzed 481 lesions from 453 consecutive patients with symptomatic peripheral artery diseases (Rutherford category 1-6) who underwent endovascular therapy with implantation of Innova™ self-expanding nitinol stent for FP lesions. The primary outcome measure was the 3-year restenosis rate based on doppler-ultrasound or angiographic criteria. The secondary outcome measures included the rates of 3-year major amputation and major adverse limb events.. Restenosis following Innova™ implantation was found in 61% of the cases at 3 years. At the end of 3 years, the rates of major amputations and major adverse limb events were 3 and 31%, respectively. In cases free from restenosis at 1 year, no predictive factors for restenosis at 3 years could be determined.. The present study demonstrated mid-term clinical outcomes after Innova™ stent implantation for the treatment of FP lesions in a real-world population. The Innova™ stent demonstrated acceptable clinical outcomes in a real-world setting.

Topics: Alloys; Femoral Artery; Humans; Peripheral Arterial Disease; Popliteal Artery; Prosthesis Design; Retrospective Studies; Stents; Treatment Outcome; Vascular Patency

To evaluate technical success, safety and efficacy of post-dilatation of an interwoven nitinol stent using a paclitaxel-coated balloon (PCB) for revascularization of complex femoro-popliteal lesions. Thirty patients (26 male, mean age 70 ± 7 years) suffering from peripheral artery disease (PAD) (Rutherford category II-III) underwent revascularization of chronic total occlusions (n = 22, 73%) or severe stenosis (n = 8, 27%) of the femoro-popliteal segment. Mean lesion length was 251 ± 85 mm. Lesions were treated by pre-dilatation (POBA), implantation of a helical interwoven stent and post-dilatation with a PCB. Technical success was defined as residual stenosis < 30%. Follow-up included clinical visits, duplex ultrasound and ABI at 6 and 12 months. Endpoints were patency (re-stenosis < 50%), complications, improvement of Rutherford category and ABI. Regarding patency two sub-groups were compared: long-("LL"; < 25 cm, n = 12, mean 175 ± 38 mm) and ultra-long lesions ("ULL"; ≥ 25 cm, n = 13, mean 322 ± 43 mm). Technical success was 100%. In 1/30 patients (3.3%), a minor complication occurred (embolism). The overall primary and secondary patency rates at 12 months were 80.0% (95% CI 72.5-96.9%) and 92.0% (95% CI 84.7-100%). In the LL-sub-group, primary patency was 100%, and in the ULL-sub-group, primary patency was 61.5% (95% CI 51.8-92.3%) (p = 0.056), and secondary patency 84.6% (95% CI 71.3-100%), respectively. Rutherford category increased by at least one category in 92% of patients, ABI increased from 0.52 ± 0.13 (baseline) to 0.9 ± 0.14 (12 months) (p = 0.001). Five patients underwent target lesion revascularization during follow-up (bypass: n = 1, endovascular: n = 4). No death was observed during follow-up. Post-dilatation of an interwoven nitinol stent using a paclitaxel-coated-balloon proved to be safe and effective with promising outcomes in long- and ultra-long lesions up to 12 months of follow-up.

Topics: Aged; Alloys; Angioplasty, Balloon; Female; Femoral Artery; Humans; Leg; Male; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Prospective Studies; Prosthesis Design; Stents; Treatment Outcome; Ultrasonography, Doppler, Duplex

To investigate lumen loss (LL) at 1 year after bare nitinol stent (BNS) implantation for de novo superficial femoral artery (SFA) lesions.. The subjects were 701 consecutive patients (mean age 74±9 years; 492 men) with 817 de novo SFA lesions treated with BNS implantation between January 2004 and September 2015. The mean lesion length was 141±88 mm and the mean vessel diameter was 5.4±0.9 mm. The endpoint was LL at 1 year after BNS implantation. Secondary outcomes were restenosis and target lesion revascularization (TLR) estimated using the Kaplan-Meier method; estimates are reported with the 95% confidence interval (CI). LL was defined as the minimum lumen diameter immediately after BNS implantation minus that at 1 year measured by angiographic quantitative vessel analysis. The distribution of LL in the overall population was estimated using an accelerated failure time model.. Mean LL at 1 year was estimated to be 1.74±1.28 mm (95% CI 1.63 to 1.84). Current smoking was positively associated with LL (p=0.015), whereas lack of cilostazol use was correlated with an increase in LL (p=0.001). Reference vessel diameter and lesion length did not have any significant association with LL at 1 year. The 1-year cumulative estimate of restenosis was 25% (95% CI 22% to 28%); the corresponding value for TLR was 18% (95% CI 15% to 21%).. Mean LL progressed by at least 1.6 mm up to 1 year after BNS implantation. The risk factors for increased LL were current smoker and lack of cilostazol use.

Topics: Aged; Aged, 80 and over; Alloys; Female; Femoral Artery; Humans; Male; Peripheral Arterial Disease; Popliteal Artery; Risk Factors; Stents; Treatment Outcome; Vascular Patency

To compare the long-term clinical outcomes after self-expandable bare nitinol stent (BNS) implantation between hemodialysis (HD) and non-HD patients with femoropopliteal (FP) disease.. Although a BNS has been commonly used in patients with FP disease, the long-term efficacy of BNSs in HD patients remains unknown.. In total, 427 HD patients treated with a BNS for FP disease were enrolled, along with 157 non-HD patients as a control group. Over the following 5 years, the incidence of target lesion revascularization (TLR), major amputation and mortality was investigated. We also performed propensity-score matching analysis.. The 5-year TLR rate (45.2 vs. 32.5%, p = .013) and mortality rate (39.3 vs. 14.0%, p = .0002) were significantly higher in the HD group than in the non-HD group. The major amputation rate was comparable between the groups (7.2% in the HD group vs. 2.8% in the non-HD group, p = .16). In the propensity-score-matched cohort, the TLR rate, and mortality rate were remained higher in the HD group than in the non-HD group (48.9 vs. 34.1%, hazard ratio [HR] 2.11, 95% confidence interval [CI] 1.30-3.49, p = .0024, and 47.9 vs. 12.0%, HR 3.38, 95% CI 1.86-6.56, p < .0001, respectively). The adjusted amputation rate was consistently similar between the groups (1.7% in the HD group vs. 2.7% in the non-HD group, HR 0.90, 95% CI 0.26-2.99, p = .86).. The TLR rate and mortality at 5 years post BNS implantation for FP disease were significantly higher in HD patients than in non-HD patients, though the limb salvage rate was similar.

Topics: Alloys; Femoral Artery; Humans; Peripheral Arterial Disease; Popliteal Artery; Prosthesis Design; Renal Dialysis; Risk Factors; Stents; Treatment Outcome; Vascular Patency

The study sought to compare the safety and effectiveness of drug-coated balloon (DCB) with bare nitinol stent in patients with complex femoropopliteal(FP) lesions in real-world practice.. Patients with symptomatic (Rutherford stage 2 to 5) femoropopliteal lesions who underwent DCB or bare nitinol stent implantation at the Department of Cardiovascular Surgery of China-Japan Friendship Hospital from June 2016 to September 2017 were included. Demographics, angiographic and procedural variables were included. Freedom from target lesion revascularization (TLR), primary patency and major adverse events were obtained from follow-up results at 3,6 and12 months. Descriptive analysis was performed on all variables.. A total of 90 eligible patients were enrolled, which included 51 DCB subjects (mean age, 63.1 ± 13.2 years; 76.5% male) with 55 lesions and 39 nitinol stent subjects (mean age, 66.5 ± 10.5 years; 61.5% male) with 42 lesions. Significant higher primary patency was observed in the DCB group compared with the stent group (74.5% vs. 52.4%; log-rank test P = 0.018; HR 0.335, 95%CI 0.124-0.903, P = 0.031). The rates of freedom from TLR (f-TLR) were 78.2% and 59.5% (log-rank test P = 0.032) for the DCB group and the stent group, respectively, at 12 months. CD-TLR rates were 18.2% vs. 38.1% with a P-value of 0.023. Female sex (HR 6.122, 95%CI 1.880-19.934, P = 0.003), lesion length over 20 cm (HR 5.514, 95%CI 2.312-13.148, P < 0.001) and renal insufficiency (HR 2.609, 95%CI 1.087-6.260, P = 0.032) were suggested as independent risk factors of reducing primary patency. There were no significant differences in major adverse events between the 2 groups.. The result above demonstrates that DCB treatment has higher primary patency and lower TLR at 12 months than nitinol stent. These data confirm the safety and effectiveness of the DCB for patients with complex femoropopliteal lesions.

Topics: Aged; Alloys; Angioplasty, Balloon; Coated Materials, Biocompatible; Female; Femoral Artery; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Nickel; Peripheral Arterial Disease; Popliteal Artery; Proportional Hazards Models; Prosthesis Design; Retrospective Studies; Self Expandable Metallic Stents; Stents; Titanium; Vascular Patency

Despite considerable morbid-mortality rates, common femoral endarterectomy is still considered the gold standard for atherosclerotic common femoral artery (CFA) disease. The aim of this study was to demonstrate computed tomography angiography based long-term patency after CFA stent placement and to analyze associated risk factors for restenosis.. A retrospective and observational study was carried out in consecutive patients treated with endovascular stent placement in CFA lesions. A clinical follow-up and imaging study was performed using MD-CTA to assess different degrees of in stent restenosis (ISR) and primary, assisted, and secondary patency rates.. In a 5-year period, 35 extremities were treated in 33 patients with self-expandable nitinol stents. The technical success was 100% without complications related to the procedure. The mean follow-up (FU) was 32.2 months, and 8 limbs were lost. The degree of CFA stenosis was reduced from 79.69 ± 26.47% to 11.23 ± 24.53%. ISR < 20%, 20-70%, and ≥ 70% was evident in 15 (55.6%), 9 (33.3%), and 3 (11.1%) limbs, respectively. Estimated primary, assisted, and secondary patency was 79.5, 96.3, and 96.3%, respectively, after 24 months and 79.5, 96.3, and 96.3%, respectively after 60 months, with a freedom of clinical driven target lesion revascularisation rate of 87.8%.. Endovascular treatment with self-expandable nitinol stents in CFA lesions had a high technical success rate and was related to few complications. A mild form of intimal hyperplasia was observed in a considerable number of cases. However, long-term patency was high; therefore, CFA stent placement might be a suitable therapeutic alternative in selected patients.

Topics: Aged; Aged, 80 and over; Alloys; Computed Tomography Angiography; Constriction, Pathologic; Endovascular Procedures; Female; Femoral Artery; Humans; Male; Middle Aged; Peripheral Arterial Disease; Predictive Value of Tests; Recurrence; Retrospective Studies; Risk Assessment; Risk Factors; Self Expandable Metallic Stents; Time Factors; Treatment Outcome; Vascular Patency

Self-expanding nitinol stent (SENS) implantation is commonly oversized in the superficial femoral artery (SFA), and leads to chronic outward force (COF) and in-stent restenosis (ISR). This study aimed to investigate the impact of COF of oversizing SENS on ISR of SFA.. In patients with implanted SENS in SFA, intimal hyperplasia especially between proximal segment and distal segment was evaluated by quantitative angiography, and the impact of COF on mid-term angiographic outcomes was investigated. In addition, porcine model with implanted SENS was used to evaluate the impact of COF on angiographic and histopathologic outcomes at 1 month. Excised stented arteries were evaluated by histopathologic analysis.. COF is an important cause of restenosis in the distal portion of the SFA stent. Optimal sizing of the SFA stent is important to reduce the incidence of restenosis. Therefore, COF was an important factor of restenosis following distal SFA stenting.

Topics: Alloys; Angioplasty; Animals; Constriction, Pathologic; Female; Femoral Artery; Hemodynamics; Humans; Models, Animal; Neointima; Peripheral Arterial Disease; Prosthesis Design; Prosthesis Failure; Recurrence; Registries; Retrospective Studies; Risk Factors; Self Expandable Metallic Stents; Stress, Mechanical; Sus scrofa; Time Factors; Treatment Outcome

To examine the efficacy and durability of an interwoven self-expanding nitinol stent for the treatment of superficial femoral and popliteal arteries.. Consecutive patients with severely diseased superficial femoral and popliteal arteries who received SUPERA® stents were retrospectively identified.The patients were followed for 12 months by Doppler ultrasound examinations, stent roentgenograms, and estimation of Rutherford-Becker class and ankle-brachial index.. From July 2012 to May 2014, 42 limbs in 36 patients (mean age, 61.5 ± 7.5 years; 75% male) were treated with angioplasty and primary stenting. Total occlusions were present in 14 limbs, and 63.8% had either moderate or severe calcification. The mean (±SD) lesion length was 105 mm (±28). Primary patency was 91.4% at 6 months and 85.7% at 12 months. The ankle brachial index increased from 0.57 ± 0.19 preoperative to 0.91 ± 0.12 postoperative. There was no procedural or device-related morbidity or mortality after revascularization and only one major amputation was observed on follow-up.. Our experience shows that, Supera stents are safe and effective in our cohort of patients, with acceptable patency rates. There were no stent fractures so far even with stenting of the femoropopliteal segments. Stent design provides a viable option for high-grade obstructive disease in the femoropopliteal artery.

Topics: Aged; Aged, 80 and over; Alloys; Amputation, Surgical; Angioplasty, Balloon; Female; Femoral Artery; Humans; Limb Salvage; Male; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Prosthesis Design; Retrospective Studies; Self Expandable Metallic Stents; Severity of Illness Index; Time Factors; Treatment Outcome; Vascular Patency

Zilver PTX nitinol self-expanding drug-eluting stent with paclitaxel coating is effective for treatment of superficial femoral artery (SFA) disease. However, as with any stent, it induces a measure of vascular inflammatory response. The current clinical trial (NCT02734836) aimed to assess vascular patency, remodeling, and inflammatory markers with intravascular optical coherence tomography (OCT) in patients with SFA disease treated with Zilver PTX stents.. Serial OCT examinations were performed in 13 patients at baseline and 12-month follow-up. Variables evaluated included neointimal area, luminal narrowing, thrombus area, stent expansion as well as measures of inflammation including, peri-strut low-intensity area (PLIA), macrophage arc, neovascularization, stent strut apposition and coverage.. Percentage of malapposed struts decreased from 10.3 ± 7.9% post-intervention to 1.1 ± 2.2% at 12-month follow-up, but one patient showed late-acquired stent malapposition (LASM). The percent of uncovered struts at follow-up was 3.0 ± 4.5%. Average expansion of stent cross-sectional area from baseline to follow-up was 35 ± 19%. The average neointimal area was 7.8 ± 3.8 mm. At 12-month follow-up, OCT analysis of Zilver PTX stent shows outward remodeling and minimal neointimal growth, but evidence of inflammation including PLIA, neovessels, thrombus and macrophages.. Thirteen patients with PAD had paclitaxel-coated stents implanted in their SFAs and were then imaged with OCT at baseline and 12-month follow-up. OCT proxy metrics of inflammation were quantified.

Topics: Aged; Aged, 80 and over; Alloys; Angioplasty, Balloon; Cardiovascular Agents; Drug-Eluting Stents; Female; Femoral Artery; Humans; Inflammation; Male; Middle Aged; Neointima; Paclitaxel; Peripheral Arterial Disease; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Risk Factors; Self Expandable Metallic Stents; Time Factors; Tomography, Optical Coherence; Treatment Outcome; Vascular Patency; Vascular Remodeling

Topics: Aged; Alloys; Endovascular Procedures; Female; Femoral Artery; Humans; Male; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Propensity Score; Prosthesis Design; Registries; Retrospective Studies; Risk Assessment; Risk Factors; Stents; Time Factors; Treatment Outcome; Vascular Patency

Treatment of peripheral arterial disease (PAD) has become increasingly dominated by endovascular interventions. The short-term outcomes of endovascular therapy have been well studied, but late outcomes remain largely unpublished; in this series, we report the late outcomes of primary nitinol stenting.. All patients undergoing primary nitinol stenting of the superficial femoral artery (SFA) and/or popliteal artery (PA) during a 10-year period by a single surgeon (S.K.) were reviewed. No attempts were made on patients with orificial or total occlusion of the SFA, PA, and proximal tibial arteries. Differences in primary patency, primary-assisted patency, secondary patency, and freedom from bypass were evaluated at 1, 5, and 9 years.. A total of 294 limbs in 240 patients were treated. One hundred and thirty additional endovascular procedures were observed during the study period averaging to 0.16 endovascular interventions per limb per year. Primary patency in TASC A/B limbs at 1, 5, and 9 years was 79%, 35%, and 19%, respectively, and in TASC C/D limbs was 62%, 11%, and 3%, respectively. Secondary patency in TASC A/B limbs at 1, 5, and 9 years was 96%, 81%, and 65%, respectively, and in TASC C/D limbs was 92%, 64%, and 41%, respectively. Freedom from bypass in TASC A/B limbs at 1, 5, and 9 years was 98%, 89%, and 85%, respectively, and in TASC C/D limbs was 95%, 78%, and 69%, respectively. Five below-the-knee amputations were observed during the study period.. An endovascular-first approach can be applied to the vast majority of femoropopliteal lesions. While the late outcomes of TASC C/D lesions are inferior to those of TASC A/B lesions, an endovascular-first approach still provides durable outcomes.

Topics: Aged; Aged, 80 and over; Alloys; Amputation, Surgical; Endovascular Procedures; Female; Femoral Artery; Humans; Limb Salvage; Male; Peripheral Arterial Disease; Popliteal Artery; Prosthesis Design; Retrospective Studies; Risk Assessment; Risk Factors; Self Expandable Metallic Stents; Time Factors; Treatment Outcome; Vascular Patency

Topics: Alloys; Angioplasty, Balloon; Constriction, Pathologic; Critical Illness; Femoral Artery; Humans; Ischemia; Male; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Prosthesis Design; Stents; Treatment Outcome; Vascular Calcification; Vascular Patency

The aim of this study was to evaluate the safety and performance of the sinus-SuperFlex-635 self-expandable nitinol stent (Optimed GmbH) for the treatment of steno-occlusive lesions in the superficial femoral artery (SFA) and proximal popliteal artery (PPA).. The prospective, multicenter, observational HERO study recruited 117 eligible patients (83 men; mean age 69.4±9.7y) from 7 centers in Belgium.. A total of 129 stents were successfully deployed in 121 lesions in 117 patients (100%). The patients presented with symptomatic ≥50% stenosis or chronic total occlusion (CTO) (30.6%). Mean lesion length was 71.4±56.3 mm. Moderate to severe calcification was present in 82.6% of the lesions. Acute lesion success (<30% residual stenosis) was achieved in 96.0%. There were no in-hospital serious adverse events. Duplex ultrasound-driven primary patency at 12 months was recorded in 84 of 107 (78.5%) lesions. The overall target lesion revascularization (TLR) rate was 8.4% at 12 months; the target extremity revascularization (TER) rate was 4.7%. Clinical assessment at 12 months demonstrated improvement by at least 1 Rutherford class, without the need for TLR (i.e. primary sustained clinical improvement) in 83.9% of patients and with the need for TLR in 90.6% of patients (i.e. secondary sustained clinical improvement).. Based on the high primary patency, low stent fracture rate and significant clinical improvement, combined with refined stent design and long stent availability, the sinus-SuperFlex-635 self-expandable nitinol stent proves its value in the treatment of complex femoropopliteal lesions.

Topics: Aged; Aged, 80 and over; Alloys; Belgium; Endovascular Procedures; Female; Femoral Artery; Humans; Male; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Prospective Studies; Prosthesis Design; Registries; Self Expandable Metallic Stents; Time Factors; Treatment Outcome; Vascular Calcification; Vascular Patency

The aim of this study was to report midterm outcomes (up to 72 months) of patients who received femoropopliteal helical interwoven nitinol stents (Supera Peripheral Stent System, Abbott Laboratories, Inc, Webster, Tex).. Prospectively collected data on patients treated with femoropopliteal non-drug-eluting angioplasty and helical interwoven nitinol stents were retrospectively analyzed. Patients were followed up with 6, 12, 18, 24, 36, 48, 60, and 72 months clinical, duplex, and radiographic assessments. Restenosis is defined as 50% or greater restenosis of the target lesion on duplex ultrasound imaging.. From October 2011 to September 2018, 315 patients (198 males) with 360 legs and a median age of 78 years (range, 46-100 years) were included. Symptoms of claudication, rest pain, and tissue loss were found in 212 (58.9%), 53 (14.7%), and 150 (41.7%) legs, respectively. In 176 (48.9%) legs, stents were placed in the popliteal segments. The mean stented lesion length was 119.0 mm (range, 40-450 mm). The overall primary patency rates at 6, 12, 24, 36, 48, 60, and 72 months were 90.6%, 80.5%, 73.8%, 68.9%, 65.3%, 63.1%, and 63.1%, respectively. The ankle-brachial pressure index increased from 0.58 ± 0.18 preoperatively to 0.87 ± 0.16 postoperatively. There were no stent fractures on follow-up. Patency rate was not statistically affected by indication of treatment, lesion calcification, or diabetes, but the length of stents and involvement of popliteal arteries were statistically significantly worse (log-rank test, P = .011 and P = .005). Stents with inner diameters of 4-mm had an initial lower patency compared with 5-mm stents, but the patency rates merged and crossed over at 46 months (log-rank test, P = .131). There was no procedural- or device-related morbidity or mortality, and there were nine major amputations after revascularization.. This study provides long-term clinical data demonstrating that Supera stents are effective and durable.

Topics: Aged; Aged, 80 and over; Alloys; Amputation, Surgical; Endovascular Procedures; Female; Femoral Artery; Humans; Limb Salvage; Male; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Prosthesis Design; Recurrence; Retrospective Studies; Risk Factors; Stents; Time Factors; Treatment Outcome; Vascular Patency

Topics: Aged; Alloys; Angiography; Angioscopy; Endovascular Procedures; Femoral Artery; Humans; Male; Multimodal Imaging; Peripheral Arterial Disease; Polytetrafluoroethylene; Predictive Value of Tests; Prosthesis Design; Prosthesis Failure; Stents; Tomography, Optical Coherence; Ultrasonography, Interventional

Topics: Aged, 80 and over; Alloys; Angioplasty, Balloon; Angioscopy; Female; Femoral Artery; Humans; Peripheral Arterial Disease; Predictive Value of Tests; Prosthesis Design; Prosthesis Failure; Stents; Treatment Outcome

To examine clinical outcomes for combination therapy of heparin-bonded covered stent [VIABAHN™ stent (VIA)] and bare-nitinol stent (BNS), and to determine independent predictors of restenosis after VIA implantation assessed by intravascular ultrasound (IVUS). A retrospective analysis was conducted on VIA use in the femoropopliteal artery of 71 patients (81 lesions) treated between June 2012 and November 2018. We divided the treated lesions into two groups; that is, whether BNS was added at the proximal site of the VIA or not (combination of VIA and BNS group [COM; n = 21] vs. VIA group [n = 60]). The median follow-up duration was 21.6 months (interquartile range, 13.2-28.8 months). Restenosis at 2 years was observed in 5 lesions (33%) in COM group and 17 lesions (38%) in VIA group (log-rank, P = 0.74). In VIA group, 14 lesions developed restenosis within 12 months. Multivariate logistic regression analysis of VIA group revealed that the proximal plaque burden was an independent predictor of restenosis within 12 months after VIA implantation (odds ratio 1.15, 95% confidence interval 1.01-1.30, P = 0.01), with the optimal cutoff value of 43% (area under the receiver operator characteristic curve 0.79, sensitivity 91%, specificity 69%). A remaining plaque of > 43% at the proximal reference segment was an independent predictor of restenosis after VIA implantation. When residual stenosis is observed at the proximal site of SFA after VIA implantation, combination therapy of VIA and BNS would be an optimal management.

Topics: Aged; Aged, 80 and over; Alloys; Anticoagulants; Constriction, Pathologic; Endovascular Procedures; Female; Femoral Artery; Heparin; Humans; Male; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Predictive Value of Tests; Recurrence; Retrospective Studies; Risk Assessment; Risk Factors; Stents; Time Factors; Treatment Outcome; Ultrasonography, Interventional; Vascular Patency

Topics: Alloys; Angioscopy; Endovascular Procedures; Femoral Artery; Humans; Male; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Predictive Value of Tests; Prosthesis Design; Stents; Time Factors; Treatment Outcome

To present a novel angiographic scoring system that stratifies the risk of restenosis after endovascular therapy (EVT) to inform the decision to use paclitaxel-eluting devices in the femoropopliteal segment.. A prospective, multicenter registry including 1799 limbs of 1578 patients (mean age 74±9 years; 1090 men) with symptomatic peripheral artery disease undergoing intravascular ultrasound-supported femoropopliteal EVT was used as the basis for developing the angiographic score. Multivariable analysis identified baseline patient and limb characteristics associated with restenosis at 12 months. These risk factors for 12-month restenosis were explored using a generalized linear mixed model with a logit-link function in which the inter-institutional and inter-subject variability were treated as random effects. The multiple imputation method was adopted to address missing data. Results of the regression analysis are presented as the odds ratio (OR) with 95% confidence interval (CI).. Twelve-month primary patency was estimated to be 65.1% (95% CI 62.7% to 67.5%). After multivariable analysis, distal reference vessel diameter per 1 mm (OR 0.71, 95% CI 0.62 to 0.81, p<0.001), lesion length per 10 cm (OR 1.39, 95% CI 1.19 to 1.62, p<0.001), and chronic total occlusion (OR 1.56, 95% CI 1.15 to 2.10, p=0.004) were independently associated with the 12-month restenosis risk, whereas baseline patient risk factors were not. Compared to bare nitinol stent implantation, plain angioplasty (OR 2.31, 95% CI 1.67 to 3.18, p<0.001) was independently associated with a higher risk of 12-month restenosis, while drug-eluting stents (OR 0.65, 95% CI 0.43 to 0.99, p=0.045) and stent-grafts (OR 0.24, 95% CI 0.12 to 0.50, p<0.001) were independently associated with a lower risk of 12-month restenosis. The angiographic score, which was developed by using the 3 angiographic factors but not the TransAtlantic Society Consensus II (TASC) class, was significantly and independently associated with 12-month restenosis.. The current study demonstrated a novel angiographic score for 12-month restenosis after femoropopliteal EVT in a real-world clinical practice. The developed score was significantly and independently associated with the 12-month restenosis risk, but the TASC class was not.

Topics: Aged; Aged, 80 and over; Alloys; Angioplasty; Endovascular Procedures; Female; Femoral Artery; Humans; Male; Peripheral Arterial Disease; Popliteal Artery; Prospective Studies; Prosthesis Design; Risk Factors; Stents; Treatment Outcome; Vascular Patency

To report the outcomes after treating stenotic or occluded femoropopliteal lesions with a drug-coated balloon (DCB) followed by the implantation of a thin-strut self-expanding bare metal stent in the BIOLUX 4EVER trial (. The prospective, multicenter, physician-initiated BIOLUX 4-EVER trial was conducted at 5 centers in Belgium and enrolled 120 patients (mean age 70.9±10.5 years; 79 men) with symptomatic stenotic or occluded de novo femoropopliteal lesions. A fifth of the patients had diabetes mellitus and nearly half had previous peripheral artery interventions. The lesions were a mean 83.3±49.5 mm long with a mean reference vessel diameter of 5.26±0.59 mm. Lesions were treated with a Passeo-18 Lux DCB followed by the implantation of a Pulsar-18 bare metal stent. Follow-up visits were conducted at 1, 6, 12, and 24 months postprocedure; the main outcome was primary patency at 12 months.. Technical success was obtained in all patients. Primary patency was observed in 89.9% of patients (95% CI 84.0% to 95.8%) at 12 months and in 83.5% at 24 months (95% CI 89.9% to 97.3%), and freedom from target lesion revascularization was 93.6% (95% CI 89.9% to 97.3%) and 86.1% (95% CI 79.9% to 92.3%), respectively. Ten patients died throughout the course of the trial (90.7% survival at 24 months), all of noncardiovascular causes. The ankle-brachial index improved from 0.68±0.09 at baseline to 0.93±0.11 and 0.93±0.12 at 12- and 24-month follow-up visits (p<0.001). An improvement of at least 1 Rutherford category was observed in 91 of 94 patients (96.8%) at 12 months and 78 of 83 patients (93.4%) at 24 months (p<0.001).. The combination of a Passeo-18 Lux DCB followed by a Pulsar-18 stent implantation produced safe and effective outcomes in the treatment of femoropopliteal lesions at up to 24 months. Adding paclitaxel to the bare nitinol stent platform by predilating with a Passeo-18 Lux DCB seems to increase efficacy at 1 and 2 years compared with the use of bare metal stents only, which were investigated in the precursor 4-EVER study.

Topics: Aged; Aged, 80 and over; Alloys; Angioplasty, Balloon; Belgium; Coated Materials, Biocompatible; Female; Femoral Artery; Humans; Male; Middle Aged; Paclitaxel; Peripheral Arterial Disease; Pharmaceutical Preparations; Popliteal Artery; Prospective Studies; Stents; Treatment Outcome; Vascular Patency

This report describes the successful use of a new hybrid vascular graft as a conduit for above knee femoro-popliteal bypass surgery. The graft consists of a proximal (heparin coated) expanded polytetrafluoroethylene section but ends distally as a nitinol reinforced self-expandable stent that is covered and constrained, allowing a sutureless distal anastamosis. With this graft the creation of above knee bypasses in situations where lesions extend to the popliteal artery behind the knee, or in cases where the above knee popliteal artery is severely calcified is still possible. This avoids the necessity of an infragenicular bypass with potentially inferior long-term patency rates, especially when no autologous venous bypass material is available.

Topics: Alloys; Blood Vessel Prosthesis; Blood Vessel Prosthesis Implantation; Endovascular Procedures; Femoral Artery; Humans; Peripheral Arterial Disease; Polytetrafluoroethylene; Popliteal Artery; Prosthesis Design; Self Expandable Metallic Stents; Sutureless Surgical Procedures; Treatment Outcome; Vascular Patency

Percutaneous transluminal angioplasty (PTA) is a common procedure in patients with peripheral arterial disease (PAD) affecting the femoropopliteal segment (F-P). Biomimetic nitinol stents (Supera peripheral stent, SPS) and drug eluting stents (DES) were designed to improve the longevity of F-P PTA; however, their performance has not been compared in a pragmatic setting, taking atherosclerotic plaque characteristics into account.. Overall, 296 consecutive patients (mean age: 73 y, SD: 11 y, 65% male, 68% with chronic limb threatening ischaemia) who underwent F-P PTA using SPS or DES between 2013 and 2018 were identified from a prospectively maintained institutional database. Patient and plaque characteristics, including F-P plaque characterisation based on computed tomography, were collected; 121 case matched pairs were created using a propensity score based on patient and plaque data.. During the median two year follow up, 28% of the cohort (32% SPS vs. 24% DES, p = .07) developed target lesion restenosis (TLR) > 50%. Among the 121 case matched pairs of patients, those with SPS vs. DES were not significantly more likely to develop TLR >50% (31% vs. 27%, p = .34), or stent occlusion (13% vs. 12%, p = .85 - secondary patency rate 87% vs. 88%), have a major amputation (10% vs. 6%, p = .16), require re-intervention (14% vs. 9%, p = .12), or die (7% vs.4%, p = .31). Plaque calcification did not predict restenosis or occlusion in either stent group, both in the matched and non matched populations. Multivariable analysis adjusted for patient and plaque characteristics revealed that the main predictors of restenosis >50% at two years were female sex [odds ratio (OR): 2.05, p = .01], hypertension (OR: 2.10, p = .04) and previous F-P occlusion (OR: 1.35, p = .04).. Medium term results following F-P PTA with either SPS or DES are comparable, regardless of plaque calcification and patient characteristics.

Topics: Aged; Alloys; Angioplasty; Computed Tomography Angiography; Extremities; Female; Femoral Artery; Graft Occlusion, Vascular; Humans; Limb Salvage; Male; Outcome and Process Assessment, Health Care; Peripheral Arterial Disease; Plaque, Atherosclerotic; Popliteal Artery; Prognosis; Stents; Vascular Calcification; Vascular Patency

Information on performance of different stent platforms in endovascular revascularisation of femoropopliteal lesions is controversial and scarce.. Interwoven nitinol (INS, Supera) were compared with drug eluting (DES, Zilver PTx) stents with primary intervention for femoropopliteal lesions. The primary endpoint was time to clinically driven target lesion revascularisation (CD-TLR) within 12 months. Secondary endpoints were time to death, amputation and composite of death, amputation and CD-TLR. Due to the retrospective analysis, inverse probability treatment weighted (IPTW) Cox models were calculated to reach more similar patient populations with weights for the average treatment effect of the population. The two sensitivity analyses were propensity score matching and adjustment for covariates.. At 12 months, the cumulative incidence of CD-TLR in the INS group (13%) and DES group (18%) did not differ (HR 1.36, 95% CI 0.56-3.31). A significant interaction between stents used and grade of calcification was observed (p = .006). HR for CD-TLR was 6.4 (95% CI 1.3-32.5) in none to mildly calcified favouring INS, and 0.3 (95% CI 0.1-1.3) for moderate to severely calcified lesions favouring DES. Stent efficiency did not differ comparing treatment of popliteal lesions (HR 0.80; 95% CI 0.21-3.13). Sensitivity analyses confirmed the primary efficacy outcome for either adjusted (HR 1.16; 95% CI 0.51-2.62) or matched analysis (HR 1.35; 95% CI 0.50-3.62)). Interaction of stents with calcification grade was lost for adjusted (HR 0.28; 95% CI 0.06-1.19) and matched analysis (HR 0.53; 95% CI 0.10-2.91).. Both stents (INS and DES) showed comparable results regarding CD-TLR in femoropopliteal lesions, so that one stent could not be favoured over the other, even for calcified or popliteal artery lesions.

Topics: Aged; Aged, 80 and over; Alloys; Angiography, Digital Subtraction; Blood Vessel Prosthesis Implantation; Drug-Eluting Stents; Endovascular Procedures; Female; Femoral Artery; Humans; Male; Middle Aged; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Prosthesis Design; Retrospective Studies; Self Expandable Metallic Stents; Treatment Outcome; Vascular Calcification

Although the Innova. In this multicenter study, 481 lesions in 453 consecutive patients with peripheral artery disease (PAD) (74±9 years; male, 70%; diabetes mellitus, 61%; dialysis, 27%; critical limb ischemia, 37%) who underwent endovascular therapy with the implantation of Innova. The mean lesion length was 18±10 cm. One-year restenosis and major adverse limb event rates were 36% and 18%, respectively. Multivariate analysis revealed that the presence of diabetes mellitus (odds ratio [OR]: 1.83; 95% confidence interval [CI]: 1.07-3.13), distal reference vessel diameter (OR: 1.86; 95% CI: 1.09-3.16), spot stenting (OR: 2.27; 95% CI: 1.27-4.06), and lack of one-year cilostazol treatment (OR: 0.58; 95% CI: 0.33-1.00) were independent risk factors for one-year restenosis.. The current study demonstrated one-year clinical outcomes after Innova

Topics: Aged; Alloys; Constriction, Pathologic; Female; Femoral Artery; Follow-Up Studies; Humans; Male; Peripheral Arterial Disease; Popliteal Artery; Stents; Treatment Outcome

Topics: Aged; Alloys; Angioscopy; Antineoplastic Agents; Endovascular Procedures; Femoral Artery; Humans; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Male; Neointima; Peripheral Arterial Disease; Predictive Value of Tests; Protein Kinase Inhibitors; Pyrimidines; Stents; Time Factors; Treatment Outcome; Wound Healing

The Supera peripheral stent system has a woven wire design that may confer a potential advantage and has higher resistive radial strength of traditional stents, which gives it the ability to avoid kinking. Because a stent is a permanent implant in the target vessels and they would be subjected to a wide variety of torsion, compression, and stress, a rupture is not surprising. Only three cases of ruptured Supera stents have been published in literature. We present a case of P2 popliteal segment thrombosis secondary to Supera stent fracture. A 51-year-old male patient presented with lifestyle-limiting intermittent claudication after 6 months of popliteal recanalization and Supera stent implantation. The computed tomography angiography demonstrated a popliteal artery occlusion secondary to stent fracture. The lesion was satisfactorily treated by endovascular recanalization and with a new Supera stent deployment. The duplex examination after 3 and 6 months demonstrated stent's permeability, and the plain anteroposterior and lateral radiographs did not reveal new stent fractures. Our data suggested that Supera stents are not free of fractures during follow-up and their treatment depends on the type of fracture, with the possibility for endovascular treatment in type III fractures.

Topics: Alloys; Angioplasty, Balloon; Computed Tomography Angiography; Constriction, Pathologic; Humans; Male; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Prosthesis Design; Prosthesis Failure; Retreatment; Stents; Treatment Outcome; Vascular Patency

The aim of this study was to elucidate the vascular responses to paclitaxel-eluting stent (Zilver PTX stent) in superficial femoral artery lesion at different elapsed times using angioscopy. Patients who received Zilver PTX stent implantation from five centers were enrolled. We performed angioscopic examinations at 2, 6, and 12 months after implantation and evaluated neointimal coverage (NIC) grade, intra-stent thrombus (IS-Th) grade, and presence of yellow plaque. NIC grade 0 was defined as stent struts exposed; grade 1, struts transparently visible although covered; grade 2, struts embedded in the neointima, but translucent; and grade 3, struts fully embedded and invisible. IS-Th was graded as follows: grade 0 (none), 1 (focal), and 2 (diffusely spread). Angioscopic follow-up evaluation was performed at 2 months (25 patients, 42 lesions), 6 months (18 patients, 23 stents), and 12 months (14 patients, 24 stents) after stent implantation. Dominant NIC grade significantly increased over time; however, 16.3% of the cases had NIC grade 1 or 2 at 12 months. IS-Th grade decreased; however IS-Th and yellow plaque were persistently observed in 62.5% and 83.3% cases, respectively, at 12 months. An ongoing healing response was observed at 12 months after implantation; however, thrombogenic findings were noted. Prolonged dual antiplatelet therapy could potentially enhance the clinical utility of Zilver PTX.

Topics: Aged; Aged, 80 and over; Alloys; Angioscopy; Cardiovascular Agents; Cell Proliferation; Drug-Eluting Stents; Endovascular Procedures; Female; Femoral Artery; Humans; Japan; Male; Middle Aged; Neointima; Paclitaxel; Peripheral Arterial Disease; Platelet Aggregation Inhibitors; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Registries; Risk Factors; Self Expandable Metallic Stents; Time Factors; Treatment Outcome; Wound Healing

Purpose The present study aimed to determine the safety and efficacy of a drug-coated balloon inflated within a thin-strut self-expanding bare-metal stent in patients with severe and complex femoropopliteal occlusive disease. Methods This prospective study used the Pulsar-self-expanding stent and Passeo-18 Lux drug-coated balloon in patients with severe and complex femoropopliteal occlusive disease. The primary endpoint was the 12-month primary patency, and the secondary endpoints included 24-month primary patency, assisted primary patency, secondary patency, and clinically associated target lesion revascularisation. Results The study included 44 patients (51 limbs). The mean age of the patients was 67.6 ± 10.2 years, with 73% men. Chronic limb severity was classified as Rutherford Category III in 41% of the patients, stage IV in 31%, and stage V in 27%. Lesions were predominantly Trans-Atlantic Inter-Society Consensus (TASC 2007) D (51%) and C (45%), with 32 (63%) chronic total occlusions. Procedural success was obtained in all cases. The mean lesion length was 200 ± 74.55 mm (95% CI = 167.09-208.01) with a mean number of stents per limb used of 1.57 ± 0.70 (95% CI = 1.37-1.76). Distal embolisation occurred in two patients. The primary patency rates at the 12- and 24-month follow-up were 94% (95% CI = 82.9-98.1) and 88% (95% CI = 75.7-94.5), respectively. The assisted primary was 94% (95% CI = 82.9-98.1) and secondary patency was 96% (95% CI = 85.2-99.0) at 24-month follow-up. The cumulative stent fracture rate at the 24-month follow-up was 10%. Freedom from clinically driven target lesion revascularisation was 94% (95% CI = 83-98%) at 12-month follow-up and 88% (95% CI = 76-94%) at 24-month follow-up, with two patients requiring a bypass graft. Conclusion Our novel approach involving the combination of a thin-strut bare-metal stent and a drug-coated balloon may be safe and effective, with sustainable and promising clinical outcomes up to 24 months after treatment.

Topics: Aged; Alloys; Angioplasty, Balloon; Australia; Cardiovascular Agents; Coated Materials, Biocompatible; Constriction, Pathologic; Endovascular Procedures; Female; Femoral Artery; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Prospective Studies; Prosthesis Design; Self Expandable Metallic Stents; Severity of Illness Index; Time Factors; Treatment Outcome; Vascular Patency

Objective The aim of this study was to compare the drug-eluting balloon with self-expanding interwoven nitinol stent deployment in patients with complex femoropopliteal lesions. Methods We retrospectively identified patients at our clinic with complex femoropopliteal artery lesions treated either with self-expanding interwoven nitinol stent or drug-eluting balloon. All patients had ankle-brachial index measured before and after the intervention, and regular clinical follow-up with Doppler ultrasonography was performed at six months and one year. Patients underwent peripheral angiography if needed. Results From April 2012 to July 2015, 107 patients with complex femoropopliteal lesions treated with using self-expanding interwoven nitinol stent ( N = 49, mean length 143.5 mm, mean follow-up of 14.1 ± 3.7 months) or drug-eluting balloon ( N = 58, mean length 140.6 mm, mean follow-up of 13.8 ± 4.1 months). The technical success rate was 100% in Supera® and 96.6% in drug-eluting balloon group. There were seven restenosis in self-expanding interwoven nitinol stent (SUS) group (84.8% patency) and 11 restenosis in drug-eluting balloon group (79.2% patency). A significant increase in the ankle-brachial index in both groups after intervention demonstrated a hemodynamic success (SUS group 0.45 ± 0.06, drug-eluting balloon group 0.43 ± 0.07). The mean Rutherford Becker Class significantly decreased in both groups after a follow-up of 12 months (SUS group 0.70 ± 0.73, drug-eluting balloon group 0.74 ± 0.75). Conclusion Deploying drug-eluting balloon or self-expanding interwoven nitinol stent in patients with complex femoropopliteal lesions are both safe and effective with high patency rates with no statistical difference for one-year primary patency rates between them.

Topics: Aged; Alloys; Angiography; Angioplasty, Balloon; Ankle Brachial Index; Coated Materials, Biocompatible; Female; Femoral Artery; Humans; Male; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Prosthesis Design; Recurrence; Retrospective Studies; Risk Factors; Self Expandable Metallic Stents; Time Factors; Treatment Outcome; Turkey; Ultrasonography, Doppler; Vascular Patency

We investigated 2-year clinical outcomes after implantaton of Epic. This study was a multicenter and retrospective study. From February 2013 through October 2014, 292 lesions (chronic total occlusion, 21%; TASC Ⅱ C/D, 35%) in 217 consecutive patients (74±8 years; male, 81%; diabetes mellitus, 47%; dialysis, 21%; critical limb ischemia, 29%) who had undergone endovascular therapy (EVT) with Epic. The mean follow-up duration was 19.1±8.5 months. Primary patency was 87.3% at 2 years. Freedom from TLR rate was 94.1% at 2 years. Multivariate analysis revealed that the presence of diabetes mellitus was associated with a loss of patency.. The Epic

Topics: Aged; Alloys; Constriction, Pathologic; Female; Femoral Artery; Follow-Up Studies; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Multivariate Analysis; Peripheral Arterial Disease; Popliteal Artery; Proportional Hazards Models; Retrospective Studies; Stents; Treatment Outcome

The interwoven nitinol design of the Supera stent has been shown to have superior radial strength and fracture resistance resulting in higher patency rates at 6 and 12months. A detailed sub-analysis of SUPERB trial showed differences in patency based on stent conformation post deployment. We evaluated the patency of the stent within the SAKE study cohort based on stent deployment conformation.. We retrospectively evaluated the medical records of 63 patients (77 limbs) with Rutherford class 2-5 symptoms who received Supera stents in the femoro-popliteal artery from March 2010 through May 2011 as part of the SAKE study. These patients were followed for patency and the need for re-intervention over a mean follow up of 15months. Compression or Elongation was defined as follows based on previous sub-analyses: Moderate Compression (-40 to -21%); Minimal Compression (-20 to -11%); Nominal (-10 to 10%); Minimal Elongation (11 to 20%); Moderate Elongation (21 to 40%); and Severe Elongation (>40%). Significance was determined using Chi X. The best patency rates (85.2% primary patency and 92.6% assisted primary patency) and lowest re-intervention rates (14.8%) were achieved with stent compression, followed by nominal deployment or minimal elongation, and worst outcomes (64.7% primary patency; 82.3% assisted primary patency; and 35.3% re-intervention) with stent elongation to moderate or severe degree.. Patency rates and re-intervention rates are variable based on deployment characteristics of the Supera stent. Best outcomes are achieved with compression of the stent during deployment.

Topics: Aged; Aged, 80 and over; Alloys; Endovascular Procedures; Female; Humans; Lower Extremity; Male; Medical Records; Middle Aged; Peripheral Arterial Disease; Postoperative Complications; Prosthesis Design; Retrospective Studies; Stents; Time Factors; Treatment Outcome; Vascular Patency

It has long been known that hydroxymethylglutaryl-coenzyme A reductase inhibitors (statins) broadly reduce cardiovascular events in patients with peripheral vascular disease. It was the goal of this study to determine whether there is an association between statin therapy and primary patency after stenting of superficial femoral and popliteal arteries.. The records of all patients undergoing primary nitinol stenting of the femoral and popliteal arteries at a single institution and by a single surgeon during a 10-year period were reviewed. Demographic characteristics of the patients and risk factors were identified. TransAtlantic Inter-Society Consensus (TASC II) classifications were determined for all stented lesions. Analysis was performed to determine whether the use of statins at the time of stent placement was associated with a change in rates of primary patency. Loss of primary patency was said to have occurred when an intrastent occlusion or a ≥70% stenosis was identified by arterial duplex ultrasound or angiography. Kaplan-Meier survival curves were plotted, and differences between groups were tested by log-rank method.. Between 2004 and 2014, primary femoral or popliteal stenting was performed on 308 limbs in 250 patients. At the time of intervention, 52.4% of these patients were being treated with statin therapy; 137 interventions were done for claudication and 113 for critical limb ischemia. Of the lesions treated, 165 were TASC A or B and 85 were TASC C or D. Primary patency rates for all stented lesions were 75%, 54%, and 35% at 12, 24, and 36 months. The patency rates at 12, 24, and 36 months, respectively, were 80%, 55%, and 40% for those taking statins and 68%, 49%, and 28% for those not taking statins (P = .178). Statin therapy demonstrated a trend toward an association with improved primary patency rates in TASC A/B lesions but had no association in TASC C/D lesions (TASC A/B, P = .056; TASC C/D, P = .537). Statin compliance was found to be 87% at a mean follow-up of 24.1 months.. Although the use of statins has been shown to reduce cardiovascular morbidity and mortality in patients with peripheral vascular disease, overall there is not an association of these drugs with improved primary patency after primary stenting of femoral and popliteal artery lesions. However, when limbs are stratified for severity, less severe (TASC A/B) lesions demonstrated a trend toward a significant association between statin use and improved primary patency. This finding was not seen in more severe (TASC C/D) disease.

Topics: Aged; Aged, 80 and over; Alloys; Angiography; Critical Illness; Endovascular Procedures; Female; Femoral Artery; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Intermittent Claudication; Ischemia; Kaplan-Meier Estimate; Los Angeles; Male; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Proportional Hazards Models; Prosthesis Design; Retrospective Studies; Risk Factors; Stents; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Duplex; Vascular Patency

To evaluate the clinical and health status outcomes of patients undergoing superficial femoral artery (SFA) revascularization using the Shape Memory Alloy Recoverable Technology (S.M.A.R.T.®) nitinol self-expanding stent through 3 years of follow-up.. Limited long-term data are available describing the durability of benefits after femoropopliteal revascularization.. In a multicenter, prospective, core-lab adjudicated study, 250 subjects with de novo or restenotic femoropopliteal arterial lesions were treated with the S.M.A.R.T.® stent. The primary endpoint of target vessel patency, a composite of ultrasound-assessed patency and freedom from clinically driven target lesion revascularization (TLR), was evaluated through 3 years. Secondary endpoints included stent fracture and health status. Health status was measured using generic and disease-specific instruments, including the Peripheral Artery Questionnaire (PAQ).. At 3-year follow-up, Kaplan-Meier estimated target vessel patency was 72.7%, freedom from clinically driven TLR was 78.5%, and the incidence of stent fracture was 3.6%. The PAQ summary score was markedly impaired at baseline (mean 37.3 ± 19.6 points) and improved substantially at 1 month (mean change from baseline of 31.4 points, 95% CI: 28.5-34.3; P < 0.001). Disease-specific health status benefits assessed by the PAQ were largely preserved through 3 years of follow-up (mean change from baseline, 28.0 points, 95% CI: 24.3-31.7; P < 0.0001).. In patients undergoing revascularization for moderately complex SFA disease, use of the self-expanding S.M.A.R.T® stent was associated with a high rate of target vessel patency through 3 years and led to substantial and sustained health status benefits.

Topics: Aged; Alloys; Constriction, Pathologic; Endovascular Procedures; Female; Femoral Artery; Health Status; Humans; Male; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Progression-Free Survival; Prospective Studies; Prosthesis Design; Prosthesis Failure; Quality of Life; Self Expandable Metallic Stents; Surveys and Questionnaires; Time Factors; Ultrasonography, Interventional; United States; Vascular Patency

To evaluate the 1- and 2-year patency and reintervention rates with the Zilver PTX drug-eluting stent (DES) in long complex femoropopliteal disease.. A retrospective review was conducted of 89 consecutive patients (mean age 68.7±9.8 years; 86 men) with femoropopliteal occlusive disease (Rutherford category 2-6) treated with the Zilver PTX between December 2012 and December 2013. Mean lesion length for the entire cohort was 24.2±11.3 cm (median 24.0, range 4-48). The patient population was dichotomized into a short lesion (≤20 cm) group (n=41; mean lesion length 13.3±5.6 cm) and the full DES jacket (>20 cm) group (n=48; mean lesion length 33.0±6.5 cm). Primary endpoints were duplex-derived restenosis (peak systolic velocity ratio >2.5), clinically driven reintervention, and major amputation.. The incidence of restenosis was lower in the short lesion group at 1 year (19% vs 40% for the longer lesions, p=0.050) and 2 years (39% vs 54%, respectively; p=0.331). The short lesion group had significantly lower rates of reintervention at both 1 year (2% vs 21% in long lesions, p=0.009) and 2 years (12% vs 33%, p=0.019).. Treatment of femoropopliteal lesions >20 cm with the Zilver PTX appears to be a clinically effective therapy for patients with symptomatic peripheral artery disease. However, there is an increase in restenosis and a need for reintervention that continues to progress up to 2 years.

Topics: Aged; Alloys; Angioplasty, Balloon; Cardiovascular Agents; Drug-Eluting Stents; Female; Femoral Artery; Humans; Male; Middle Aged; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Prosthesis Design; Recurrence; Retrospective Studies; Risk Factors; Self Expandable Metallic Stents; Time Factors; Treatment Outcome; Vascular Patency

The Tack implant is designed for focal, minimal metal management of dissections. This study evaluated Tacks for treating postpercutaneous transluminal angioplasty (PTA) dissection in patients with below-the-knee (BTK) arterial occlusive disease.. PTA is the most commonly used endovascular treatment for patients with occlusive disease of the BTK vessels. Post-PTA dissection is a significant clinical problem that results in poor outcomes, but currently there are limited treatment options for managing dissections.. This prospective, single-arm study evaluated patients with CLI and BTK lesions; 11.4% were Rutherford category (RC) 4 and 88.6% were RC 5. BTK occlusive disease was treated with standard PTA and post-PTA dissections were treated with Tack placement. The primary safety endpoint was a composite of major adverse limb events (MALE) and perioperative death (POD) at 30 days. Other endpoints included: device success; procedure success (vessel patency in the absence of MALE); freedom from clinically driven target lesion revascularization (CD-TLR); primary patency; and changes in RC. Data through 12 months are presented.. Thirty-two of 35 (91.4%) patients had post-PTA dissection and successful deployment of Tacks. Procedural success was achieved in 34/35 (97.1%) patients with no MALEs at 30 days. The 12-month patency rate was 78.4% by vessel, 77.4% by patient, and freedom from CD-TLR was 93.5%. Significant (P < .0001) improvement from baseline was observed in RC (75% of patients improved 4 or 5 steps).. Tack implant treatment of post-PTA dissection was safe and effective for treatment of BTK dissections and resulted in reasonable 12-month patency and low rates of CD-TLR.

Topics: Aged; Aged, 80 and over; Alloys; Angioplasty, Balloon; Critical Illness; Endovascular Procedures; Europe; Female; Humans; Ischemia; Leg; Male; New Zealand; Peripheral Arterial Disease; Progression-Free Survival; Prospective Studies; Prosthesis Design; Risk Factors; Self Expandable Metallic Stents; Time Factors; Vascular Patency; Vascular System Injuries

The DURABILITY Iliac clinical study evaluated the safety and effectiveness of 2 nitinol self-expanding stents for the treatment of atherosclerotic common and external iliac artery lesions up to 10 cm in length and >50% stenosis in subjects with Rutherford classification peripheral arterial disease stages 2-4.. DURABILITY Iliac was a prospective, multicenter, core lab adjudicated, nonrandomized clinical study enrolling 75 subjects from 15 sites in the United States and Europe. Clinical follow-up visits were at 30 days, 9 months, and 1, 2, and 3 years after procedure. The primary outcome measured was the major adverse event (MAE) rate at 9 months, defined as a composite of periprocedural death, in-hospital myocardial infarction (MI), clinically driven target lesion revascularization (CD-TLR), and amputation of the treated limb through 9 months after procedure. Secondary outcomes included primary patency rate at 9 months, clinically driven target vessel revascularization (CD-TVR), change in ankle-brachial index, and change in Walking Impairment Questionnaire score at 30 days and 9 months. Device success was defined as the ability to deploy the stent as intended at the treatment site.. The MAE rate at 9 months was 1.3% (1/75), with 1 subject experiencing a CD-TLR. No periprocedural deaths, MIs, or amputations were reported. Primacy patency at 9 months was 95.8%. Freedom from CD-TVR was 98.6% at 9 months. Subjects improved in Walking Impairment Questionnaire scores for all categories (walking impairment, walking speed, walking distance, and stair climbing) at the 30-day and 9-month visit. Device success was 100%.. The 9-month results of the DURABILITY Iliac study demonstrate the safety and effectiveness of 2 nitinol self-expanding stents for the treatment of atherosclerotic lesions of the common and external iliac arteries.

Topics: Aged; Alloys; Ankle Brachial Index; Constriction, Pathologic; Endovascular Procedures; Europe; Exercise Tolerance; Female; Hospital Mortality; Humans; Iliac Artery; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Peripheral Arterial Disease; Prospective Studies; Prosthesis Design; Recovery of Function; Risk Factors; Self Expandable Metallic Stents; Surveys and Questionnaires; Time Factors; Treatment Outcome; United States; Vascular Patency; Walking

With growing use of drug-coated balloons (DCB) for femoropopliteal (FP) artery interventions, there is limited information on rates of real-world adjunctive stent use and its association with short and long-term outcomes. We report on 225 DCB treated FP lesions in 224 patients from the Excellence in Peripheral Artery Disease (XLPAD) registry (NCT01904851) between 2014 and 2016. Cochran-Mantel-Haenszel and Wilcoxon rank sum statistics were used to compare stented (planned or 'bail-out') versus non-stented DCB treated lesions. Stents were implanted in 31% of FP DCB interventions. Among the 70 stents implanted, 46% were for 'bail-out' indications and 54% were planned. Lesions treated with stents were longer (mean 150 mm vs 100 mm; p < 0.001) and less likely to be in-stent restenosis lesions (10% vs 28%; p=0.003). Stenting was significantly more frequent in complex FP lesions, including chronic total occlusions (66% vs 34%; p < 0.001). For bail-out stenting, interwoven nitinol stents were the most common type (50%) followed by drug-eluting stents (34%) and bare-metal stents (22%). There were no differences in peri-procedural complication rates or 12-month target limb revascularization rates (18.6% vs 11.6%; p=0.162) or 12-month amputation rates (11.4% vs 11%; p=0.92) between lesions where adjunctive stenting was used versus lesions without adjunctive stenting, respectively. In conclusion, in a contemporary 'real-world' adjudicated multicenter US registry, adjunctive stenting was necessary in nearly a third of the lesions, primarily for the treatment of more complex FP lesions, with similar short and intermediate-term clinical outcomes compared with non-stented lesions. ClinicalTrials.gov Identifier: NCT01904851.

Topics: Aged; Alloys; Amputation, Surgical; Angioplasty, Balloon; Coated Materials, Biocompatible; Comorbidity; Constriction, Pathologic; Drug-Eluting Stents; Female; Femoral Artery; Humans; Limb Salvage; Male; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Prosthesis Design; Recurrence; Registries; Risk Factors; Stents; Time Factors; Treatment Outcome; United States; Vascular Access Devices

We report an unusual complication of Chocolate nitinol-constraining structure after right superficial femoral artery (SFA) angioplasty. The procedure was performed by vascular surgeons in an operating theater equipped by a portable fluoroscopy unit. Under local anesthesia, by a contralateral approach, a 7F introducer sheath was advanced through the proximal portion of the right common iliac artery. Owing to the severe aorto-iliac vessels calcification, it was not possible to place the introducer sheath into a more distal vessel, as planned. After external iliac artery (EIA) stenting (7 × 80 mm Eluvia), SFA obstruction was intraluminal crossed, and a 6 × 120 mm nitinol-constrained balloon (Chocolate; Medtronic) was advanced in place and inflated. Once the balloon came out, the nitinol-constraining structure was not attached to the balloon surface. Under fluoroscopy, the crashed nitinol mesh was identified at distal edge of previously positioned EIA stent. To prevent mesh migration, it was fixed by covering with a 7 × 40 mm stent. The procedure was then successfully completed, as planned. One-month, postoperative computed tomography angiography showed complete expansion of the stents and no significant residual stenosis (>30%) in EIA, and SFA. Chocolate's mesh was still evident between the stent and the iliac artery wall, in absence of further complications. A 3 months follow-up, patient was still completely asymptomatic for claudication.

Topics: Aged; Alloys; Angioplasty, Balloon; Computed Tomography Angiography; Femoral Artery; Humans; Iliac Artery; Male; Peripheral Arterial Disease; Prosthesis Design; Prosthesis Failure; Stents; Treatment Outcome; Vascular Patency

There has been increasing evidence to support the endovascular-first approach in the treatment of below-the-knee (BTK) lesions. Plain old balloon angioplasty (POBA), with bailout bare-metal stent scaffolding in case of flow limiting dissection or recoil, have been considered the standard treatment of choice but industries are continually developing innovative equipment and dedicated technologies, such as drug-eluting platforms whose use is increasingly extended, despite significant costs and lack of high-quality evidence to support a well-established strategy. This study's objective was to analyze the 6-year results of "standard" endovascular treatment of BTK lesions in the era of drug-eluting devices.. From August 2008 to February 2010, 21 French speaking European centers consecutively enrolled critical limb ischemia (CLI) patients with BTK lesions treated endovascularly into the Angioplastie Jambière (ANJE) registry. Primary endpoint was 1-year limb salvage, a subgroup analysis was performed to compare POBA, bare nitinol stents and balloon-expandable stents (BESs).. Of the 282 patients included (61.7%, men, mean age 75.8±10.0 years), 53.5% were diabetic and 29.4% presented with chronic kidney disease. At 1 year, complete wound healing was described in 187 patients (82.7%), the overall limb salvage rate was 94.0% with a survival rates of 89.2%. The primary and secondary patency rates were 84.5% and 91.7% respectively with significantly lower primary patency rates after stenting (80.6% vs. 87.6% after POBA; P=0.043). The rate of freedom from target lesion revascularization (TLR) was 86.3% with significantly lower rates after stenting (81.8% vs. 89.9% after POBA; P=0.01). The subgroup analysis showed no significant difference between nitinol stents, BESs and POBA in terms of limb salvage and survival rates, however, primary and secondary patency rates were significantly lower after BESs (primary and secondary patency rates of 84.0% after nitinol stents vs. 77.4% after BES vs. 87.6% after POBA; P=0.012 and 93.0% vs. 77.4% vs. 87.6%; P=0.003, respectively), as well as freedom from TLR rates (82.3% vs. 81.2% vs. 89.9%; P=0.04).. In the drug eluting era, the endovascular first approach of BTK lesions based on POBA with bailout spot stenting is feasible, affordable but most importantly remains effective and should be the first line strategy until the place of drug eluting stents is precisely defined.

Topics: Adult; Aged; Aged, 80 and over; Alloys; Amputation, Surgical; Angioplasty, Balloon; Critical Illness; Disease-Free Survival; Drug-Eluting Stents; Europe; Female; Humans; Ischemia; Limb Salvage; Male; Middle Aged; Peripheral Arterial Disease; Prosthesis Design; Registries; Risk Factors; Self Expandable Metallic Stents; Stents; Time Factors; Treatment Outcome; Vascular Patency

To present a Supera stent fracture following treatment of popliteal artery stenosis.. A 60-year-old man previously treated with angioplasty/stenting of a popliteal artery lesion with a Supera stent presented at 8 months with in-stent occlusion that proved to be secondary to stent fracture.. Supera interwoven nitinol stents, despite having higher radial force and conformability than classic tube stents, are not free from fracture. Moreover, due to their peculiar structure, a break in these stents results in complete loss of integrity and consequent device collapse, thus jeopardizing endovascular recanalization and relining.

Topics: Alloys; Angiography; Angioplasty, Balloon; Blood Vessel Prosthesis Implantation; Constriction, Pathologic; Humans; Male; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Prosthesis Failure; Stents; Treatment Outcome; Vascular Patency

Long-term outcomes of an interwoven nitinol stent design represent the best in class for treatment of lower limb arterial obstructive disease METHODS: The subjects were enrolled in an open single arm study comparing the outcomes to an FDA mandated objective performance goal (OPG).. About 325 patients (264 intention-to-treat and 64 roll-in subjects) were enrolled. Mean follow-up period was 887+/- 352 days. Treated lesion lengths were 7.8 cm ± 4.3 cm in the trial with chronic total occlusions comprising 24.6% (65/264) of subjects. Freedom from clinically driven target lesion revascularization (CD-TLR) at 12 months was 89%, at 24 and 36 months it was 84% and 82% respectively. The difference in the 12 month CD-TLR was 7% at 36 months. The difference of clinically driven-TLR at 36 months in those subjects who received their stents deployed nominally in length, compressed or elongated (between -10% and +10% nominal length) had an impact on the CD-TLR. At 2 and 3 years, freedom from CD-TLR in minimal compression was 86.7%, and was 90.0% for moderate compression. In those stents deployed with minimal, moderate, or severe elongation (10-20%, 20-40%, or >40%, respectively) freedom from CD-TLR of 84.1%, 87.4%, and 77.0% respectively at 12 months. At 2 and 3 years, freedom from CD-TLR for moderate elongation was 81.8% and 78.2%, and for severe elongation was 63.4% and 42.3%, respectively. Fractures were distinctly uncommon with this stent with a single facture event in the 36 month follow-up period.. The interwoven nitinol design stent is a stent that achieves an excellent primary patency but further maintains the durability of the stent through 36 months. Optimal stent deployment remains critical to the performance of this stent device and requires optimal vessel preparation. © 2017 Wiley Periodicals, Inc.

Topics: Aged; Alloys; Biocompatible Materials; Endovascular Procedures; Female; Humans; Intention to Treat Analysis; Lower Extremity; Male; Middle Aged; Peripheral Arterial Disease; Prosthesis Design; Prosthesis Failure; Risk Factors; Stents; Time Factors; Treatment Outcome; Vascular Patency

The aim was to compare outcomes of self expanding PTFE covered stents (CSs) with bare metal stents (BMSs) in the treatment of iliac artery occlusions (IAOs).. Between January 2009 and December 2015, 128 iliac arteries were stented for IAO. A CS was implanted in 78 iliac arteries (61%) and a BMS in 50 (49%). After propensity score matching, 94 limbs were selected and underwent stenting (47 for each group). Thirty day outcomes and midterm patency were compared; follow-up results were analysed with Kaplan-Meier curves.. Overall, iliac lesions were classified by limb as TASC B (19%), C (21%), and D (60%). Technical success was 98%. Comparing CS versus BMS, the early cumulative surgical complication rate (12% vs. 12%, p = 1.0) and 30 day mortality rate (2% vs. 2%, p = 1.0) were equivalent. At 36 months (average 23 ± 17), overall primary patency was similar between CS and BMS (87% vs. 66%, p = .06), and this finding was maintained after stratification by TASC B (p = .29) and C (p = .27), but for TASC D, CSs demonstrated a higher patency rate (CS, 88% vs. BMS, 54%; p = .03). In particular, patency was in favour of CSs for IAOs > 3.5 cm in length (p = .04), total lesion length > 6 cm (p = .04), and IAO with calcification > 75% of the arterial wall circumference (p = .01).. Overall, the use of self expanding CS for IAOs has similar early and midterm outcomes compared with BMS. Even if further confirmatory studies are needed, CSs seem to have higher midterm patency rates than BMSs for TASC D lesions, IAOs with a total lesion length > 6 cm, occlusion length > 3.5 cm, and calcification involving > 75% of the arterial wall circumference. These specific anatomical parameters may be useful to the operator when deciding between CS and BMS during endovascular planning.

Topics: Adult; Aged; Aged, 80 and over; Alloys; Angioplasty, Balloon; Chi-Square Distribution; Chronic Disease; Coated Materials, Biocompatible; Computed Tomography Angiography; Constriction, Pathologic; Female; Humans; Iliac Artery; Kaplan-Meier Estimate; Logistic Models; Male; Middle Aged; Peripheral Arterial Disease; Polytetrafluoroethylene; Propensity Score; Prosthesis Design; Retrospective Studies; Risk Factors; Self Expandable Metallic Stents; Time Factors; Treatment Outcome; Vascular Patency

Objectives Various configurations of kissing stent (KS) configurations exist and patency rates vary. In response the covered endovascular reconstruction of the aortic bifurcation configuration was designed to minimize mismatch and improve outcome. The aim of the current study is to compare geometrical mismatch of kissing stent with the covered endovascular reconstruction of the aortic bifurcation configuration in vivo. Methods Post-operative computed tomographic data and patient demographics from 11 covered endovascular reconstruction of the aortic bifurcation and 11 matched kissing stent patients were included. A free hand region of interest and ellipse fitting method were applied to determine mismatch areas and volumes. Conformation of the stents to the vessel wall was expressed using the D-ratio. Results Patients were mostly treated for Rutherford category 2 and 3 (64%) with a lesion classification of TASC C and D in 82%. Radial mismatch area and volume for the covered endovascular reconstruction of the aortic bifurcation group was significantly lower compared to the kissing stent configuration ( P < 0.05). The D-ratio did not significantly differ between groups. Measurements were performed with good intra-class correlation. There were no significant differences in the post-procedural aortoiliac anatomy. Conclusions The present study shows that radial mismatch exists in vivo and that large differences in mismatch exist, in favour of the covered endovascular reconstruction of the aortic bifurcation configuration. Future research should determine if the decreased radial mismatch results in improved local flow profiles and subsequent clinical outcome.

Topics: Aged; Alloys; Angioplasty, Balloon; Aortic Diseases; Aortography; Computed Tomography Angiography; Endovascular Procedures; Female; Humans; Iliac Artery; Male; Middle Aged; Netherlands; Peripheral Arterial Disease; Prosthesis Design; Self Expandable Metallic Stents; Treatment Outcome

Preprocedural lesion length and ankle-brachial indices (ABI) synergistically predict 12-month patency and repeat revacularization in claudicants treated with bare metal nitinol stents for femoropopliteal disease. This predictive length-ABI model will permit broader evidence-based indirect comparisons of newer femoropopliteal approaches such as drug eluting balloon treatment with or without atherectomy. The length-ABI model is a step to supplement and supplant randomized controlled trials with indirect comparisons as the necessary evidence source expediting innovation and optimizing personalized endovascular therapy for infrainguinal obstructive peripheral arterial disease.

Topics: Alloys; Femoral Artery; Humans; Peripheral Arterial Disease; Popliteal Artery; Prosthesis Design; Stents; Vascular Patency

We sought to assess whether balloon angioplasty (BA) alone for small femoropopliteal disease improved the outcome following endovascular therapy as compared with stent implantation.. The optimal strategy of endovascular therapy for small vessel arteries in femoropopliteal disease remains unclear.. We performed a multicenter retrospective analysis of 337 consecutive patients (371 limbs) with femoropopliteal arteries 4.0 mm or less in diameter and 150 mm or less in length.. Cumulative 3-year incidence of primary patency was significantly higher in the BA group than in the stent group (53.8% vs. 34.2%, P = 0.002). While assisted-primary patency and freedom from any major adverse limb events were also significantly higher in the BA group than in the stent group (70.9% vs. 44.2%, P < 0.001 and 60.6% vs. 36.4%, P = 0.001, respectively), secondary patency did not significantly differ between the two groups (86.9% vs. 86.9%, P = 0.67). Predictors of restenosis were diabetes mellitus (hazard ratio [HR], 1.61; 95% confidence interval [CI], 1.14-2.31; P = 0.01), no administration of cilostazol (HR, 1.50; 95% CI, 1.07-2.13; P = 0.02), stent implantation (HR, 1.68; 95% CI, 1.15-2.41; P = 0.01), and lesion length >75.0 mm(HR, 2.09; 95% CI, 1.50-2.92; P < 0.001).. Lesions in small (<4.0 mm diameter) FP vessels demonstrated better primary patency at 3 years when successfully treated with balloon angioplasty alone as opposed to routine or bailout stenting. This difference was especially pronounced for lesions 75 to 150 mm in length.

Topics: Aged; Aged, 80 and over; Alloys; Angioplasty, Balloon; Disease-Free Survival; Female; Femoral Artery; Humans; Japan; Kaplan-Meier Estimate; Male; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Proportional Hazards Models; Prosthesis Design; Retrospective Studies; Risk Factors; Stents; Time Factors; Treatment Outcome; Vascular Patency

Prospective single-arm study, aimed at evaluating safety and effectiveness at 12 and 24 months of the paclitaxel-eluting nitinol stent (Zilver PTX), and focused in particular on the treatment of complex lesions and/or diabetic patients.. Between May 2010 and March 2012, 67 patients (78% males) were treated by Zilver PTX, because of stenosis or occlusions of the superficial femoral artery in one of two centers. The mean age of patients was 70.1±8 years. Thirty-two of 67 (48%) were diabetics, 14 (21%) active smokers and 11 (14.6%) had chronic renal failure (end stage renal disease). The average length of lesions was 104±60 mm. Occlusion was complete in 46.3% of cases, whereas severely calcified lesions were present in 30% of patients (18.8% in diabetics and 31.4% in non-diabetics). Twenty-six patients (39%) had type C or D lesions according to TASC 2.. One hundred-two stents were used (1.7±0.9 per patients); median 1 (range 1-4). All patients had successful stent placement. Primary patency, evaluated by Kaplan-Meier method was 88±0.06% at 12 months, and 68±0.1% at 24 months. In particular, the difference between diabetics (D) and non-diabetics (non-D) was not significant (P=0.07, Log-Rank). Patients turned from 4.2±1.3 to 1.6±1.3 Rutherford class. There were 5 deaths due to systemic comorbidities. There also were 3 major amputations, all of them also in the D group. Among the other patients, differences between D and non-D patients were not significant in terms of wound healing, bipedal stay and spontaneous ambulation. The mean follow-up length was 28±5 months (range 24-36 months). There was only one patient who had fracture and stent migration (1.5%). In 13 diabetic patients, tibial PTA was also associated. Additional treatment was required in 6 D and 1 non-D.. The use of Zilver PTX is safe and effective in the treatment of SFA lesions. In particular, both stent patency and functional results on the basis of both clinical and instrumental tools were similar in D and non-D, suggesting a particularly favorable activity of PTX in a subpopulation of diabetics. Further studies are required to confirm these results, which seem to be particularly promising in diabetic patients.

Topics: Aged; Aged, 80 and over; Alloys; Amputation, Surgical; Cardiovascular Agents; Diabetic Angiopathies; Drug-Eluting Stents; Endovascular Procedures; Female; Femoral Artery; Humans; Italy; Kaplan-Meier Estimate; Limb Salvage; Male; Middle Aged; Paclitaxel; Peripheral Arterial Disease; Prosthesis Design; Retreatment; Retrospective Studies; Risk Factors; Time Factors; Treatment Outcome; Vascular Patency

To report the real-world incidence and risk factors of stent thrombosis in the aortoiliac and femoropopliteal arteries in case of bare nitinol stent (BNS) or covered nitinol stent (CNS) placement from a single-centre retrospective audit.. Medical records of consecutive patients treated with peripheral stent placement for claudication or critical limb ischemia were audited for definite stent thrombosis defined as imaging confirmed stent thrombosis that presented as acute limb-threatening ischemia. Cases were stratified between aortoiliac and femoropopliteal anatomy. Cox regression analysis was employed to adjust for baseline clinical and procedural confounders and identify predictors of stent thrombosis and major limb loss.. 256 patients (n = 277 limbs) were analysed over a 5-year period (2009-2014) including 117 aortoiliac stents (34 CNS; 12.8 ± 5.0 cm and 83 BNS; 7.8 ± 4.0 cm) and 160 femoropopliteal ones (60 CNS; 21.1 ± 11.0 cm and 100 BNS; 17.5 ± 11.9 cm). Median follow-up was 1 year. Overall stent thrombosis rate was 6.1% (17/277) after a median of 43 days (range 2-192 days) and affected almost exclusively the femoropopliteal segment (12/60 in the CNS cohort vs. 4/100 in the BNS; p = 0.001). Annualized stent thrombosis rates (per 100 person-years) were 12.5% in case of CNS and 1.4% in case of BNS (HR 6.3, 95% CI 2.4-17.9; p = 0.0002). Corresponding major amputations rates were 8.7 and 2.5%, respectively (HR 4.5, 95% CI 2.7-27.9; p = 0.0006). On multivariable analysis, critical leg ischemia and CNS placement were the only predictors of stent thrombosis. Diabetes, critical leg ischemia, femoropopliteal anatomy, long stents and CNS were independent predictors of major amputations.. Placement of long femoropopliteal covered nitinol stents is associated with an increased incidence of acute stent thrombosis and ensuing major amputation. Risks are significantly lower in the aortoiliac vessels and with use of bare nitinol stents.

Topics: Acute Disease; Aged; Alloys; Amputation, Surgical; Aorta; Causality; Comorbidity; Constriction, Pathologic; Extremities; Female; Femoral Artery; Follow-Up Studies; Humans; Incidence; Intermittent Claudication; Ischemia; Male; Peripheral Arterial Disease; Popliteal Artery; Prosthesis Design; Prosthesis Failure; Retrospective Studies; Risk Factors; Stents; Thrombosis; Time Factors; Treatment Outcome; Vascular Patency

Endovascular therapy for long femoropopliteal lesions using percutaneous transluminal balloon angioplasty or first-generation of peripheral stents has been associated with unacceptable one-year restenosis rates. However, with recent advances in equipment and techniques, a better primary patency rate is expected. This study was conducted to detect the long-term primary patency rate of nitinol self-expandable stents implanted in long, totally occluded femoropopliteal lesions TransAtlantic Inter-Society Census (TASC II type C & D), and determine the predictors of reocclusion or restenosis in the stented segments.. The demographics, clinical, anatomical, and procedural data of 213 patients with 240 de novo totally occluded femoropopliteal (TASC II type C & D) lesions treated with nitinol self-expandable stents were retrospectively analysed. Of these limbs, 159 (66.2%) presented with intermittent claudication, while 81 (33.8%) presented with critical limb ischaemia. The mean-time of follow-up was 36±22.6 months, (range: 6.3-106.2 months). Outcomes evaluated were, primary patency rate and predictors of reocclusion or restenosis in the stented segments.. The mean age of the patients was 70.9±9.3 years, with male gender 66.2%. Mean pre-procedural ABI was 0.45±0.53. One-hundred-and-seventy-five (73%) lesions were TASC II type C, while 65 (27%) were type D lesions. The mean length of the lesions was 17.9±11.3mm. Procedure related complications occurred in 10 (4.1%) limbs. There was no periprocedural mortality. Reocclusion and restenosis were detected during follow-up in 45 and 30 limbs respectively, and all were re-treated by endovascular approach. None of the patients required major amputation. Primary patency rates were 81.4±1.1%, 77.7±1.9% and 74.4±2.8% at 12, 24, and 36 months respectively. Male gender, severe calcification, and TASC II D lesion were independent predictors for reocclusion, while predictors of restenosis were DM, smoking and TASC II D lesions.. Treatment of long, totally occluded femoropopliteal (TASC II C & D) lesions with nitinol self-expandable stents is safe and is associated with highly acceptable long-term primary patency rates.

Topics: Aged; Aged, 80 and over; Alloys; Angioplasty, Balloon; Blood Vessel Prosthesis Implantation; Female; Follow-Up Studies; Graft Occlusion, Vascular; Humans; Male; Middle Aged; Peripheral Arterial Disease; Retrospective Studies; Stents; Time Factors; Vascular Patency

To quantify the deformations of the femoropopliteal (FP) segment in patients undergoing endovascular revascularization and to compare the posttreatment deformations caused by primary nitinol stent implantation to those produced by percutaneous transluminal angioplasty (PTA).. Thirty-five patients (mean age 69±10 years; 20 men) scheduled for endovascular therapy were recruited for the study. During endovascular interventions, angiographic images were acquired with the legs straight and with a hip/knee flexion of 20°/70°. Image acquisition was performed before PTA for all patients, after PTA in 17 patients receiving this treatment only, and after primary stent implantation in the remaining 18 patients. A semiautomatic approach was used to reconstruct the 3-dimensional patient-specific artery models from 2-dimensional radiographs. Axial shortening and curvature changes in the arteries in vivo were calculated for the calcified, dilated, and stented regions, as well as the regions that were distal and proximal to the diseased and treated segments.. Leg flexion resulted in shortening of the artery in all investigated FP segments. The dilated arteries exhibited greater shortening compared with their stented counterparts (post-PTA 7.6%±4.9%, poststent 3.2%±2.9%; p=0.004). Leg flexion also led to an increase in the curvatures of all the sections of the FP segment. While stented arteries had significantly higher curvature values than PTA within the regions proximal to the treated sections, the choice of the treatment method did not affect the curvature of the other segments. Despite this, 40% of the stented arteries exhibited kinking during leg flexion.. The choice of the treatment method affects the postinterventional axial deformations of the FP segment but does not influence the curvature behavior. While PTA results in a more flexible artery, stents restrict the arteries' shortening capabilities. Depending on the anatomical position of the stents, this axial stiffening of the arteries may lead to chronic kinking, which may cause occlusions and, consequently, affect the long-term success of the procedure.

Topics: Aged; Alloys; Angiography; Angioplasty, Balloon; Female; Femoral Artery; Humans; Male; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Prosthesis Design; Radiographic Image Interpretation, Computer-Assisted; Stents; Time Factors; Treatment Outcome

Oversizing of the Nitinol stents in the femoro-popliteal arterial tract is commonly performed by clinicians and further encouraged by stent manufacturers. However, in spite of the procedure's supposed benefits of strong wall apposition and increased luminal gain, its effects on the mechanical behavior of arteries with peripheral arterial disease are not fully clear. In this study, finite element (FE) analyses of endovascular revascularization of an idealized artery with 70% stenosis and three different plaque types have been performed to examine the influence of Nitinol stent oversizing on the arterial stresses and acute lumen gain. The analyses included the simulation of balloon angioplasty to model plaque failure, followed by stent implantation, in which four different oversizing ratios were investigated. Results showed that balloon angioplasty was crucial in determining the stress levels of the artery prior to stent implantation and heavily affected the outcome of endovascular therapy. For all plaque types, Nitinol stent oversizing was found to produce a marginal lumen gain in contrast to a significant increase in arterial stresses. For the arteries with lightly and moderately calcified plaques, oversizing was found to be non-critical; whereas for the arteries with heavily calcified plaques, the procedure should be avoided due to a risk of tissue failure.

Topics: Alloys; Angioplasty, Balloon, Coronary; Femoral Artery; Finite Element Analysis; Humans; Models, Theoretical; Peripheral Arterial Disease; Plaque, Atherosclerotic; Stents

To analyse the patency rates of femoro-popliteal stenting with different self-expandable Nitinol stent-designs.. Two hundred and twenty-two patients (142 (64%) male; age 72.4 ± 11.6 years) with symptomatic femoro-popliteal peripheral arterial occlusive disease (PAOD) underwent percutaneous transluminal angioplasty (PTA) and stenting with three different Nitinol stents (interwoven IW: n = 70; closed-cell CC: n = 85; open-cell OC: n = 67). One-year post-procedural target lesion revascularization (TLR_12M) rates were investigated with regard to co-morbidities: diabetes (DBM), hyperlipidaemia (HLP), hypertension (RR), coronary artery disease (CAD) and degree of calcification.. Twelve-month follow-up data were available for 60, 69 and 50 patients in the IW, OC and CC groups (179 patients in total). The cumulative patency (IW: 52 (86.7%); OC: 50 (72.5%); CC: 23 (46.0%); P < 0.001) and the TLR_12M rates (IW: 8 (13.3%); OC: 19 (27.5%); CC: 27 (54.0%); P < 0.001) differed significantly, as did the subgroup analyses (DBM: P = 0.05; RR: P = 0.003; HLP: P = 0.005; CAD: P = 0.02; localization: P < 0.001; calcification: P < 0.001), with the best patency for the IW stent and the highest TLR_12M for the CC stent.. The interwoven stent-design was superior to the standard open- and closed-cell stent-designs in endovascular treatment of femoro-popliteal PAOD in a follow-up period of 12 months.. • Results of femoro-popliteal stenting are still unsatisfactory. • Comparative studies for currently available different Nitinol stent-designs are lacking. • This is a first comparative study on long-term patency of different Nitinol stent-designs. • Interwoven stent-design leads to improved long-term patency. • Interwoven stent-design leads to lower TLR than other stent-designs.

Topics: Aged; Alloys; Angioplasty; Angioplasty, Balloon; Arterial Occlusive Diseases; Coronary Artery Disease; Female; Femoral Artery; Humans; Male; Peripheral Arterial Disease; Popliteal Artery; Prosthesis Design; Reperfusion; Stents; Treatment Outcome; Vascular Patency

Preliminary results in small single-center studies after stenting with the GORE TIGRIS Vascular Stent (W. L. Gore & Associates, Flagstaff, Ariz) show promising short-term primary patency rates, but larger, multicenter studies are needed. This study therefore investigated the performance of the GORE TIGRIS Vascular Stent at three different centers in France in patients with symptomatic peripheral artery disease.. This retrospective, single-arm, multicenter cohort study included 215 patients with peripheral artery disease (Rutherford-Becker category 2-6) who were treated with the GORE TIGRIS Vascular Stent, a dual-component stent consisting of a nitinol wire frame combined with a fluoropolymer-interconnecting structure. The efficacy end point was primary patency defined by freedom from binary restenosis as derived by duplex ultrasound imaging until 2 years after the intervention. Primary, secondary, and primary assisted patency rates at 3, 6, 12, 18, and 24 months were estimated by Kaplan-Meier analysis.. The GORE TIGRIS Vascular Stent was used to successfully treat 239 lesions, of which 141 lesions were located in the superficial femoral artery and 98 in the popliteal artery. Patients were a mean age of 74 ± 12 years. Mean lesion length was 86.8 ± 44.7 mm. After 12 and 24 months, the overall primary patency rates were 81.5% and 67.2%, respectively, and primary assisted patency was 94.9% and 84.8%. Secondary patency was achieved in 99.1% at 24 months.. Our multicenter experience with the GORE TIGRIS Vascular Stent demonstrates continued good results at 2 years for endovascular treatment of challenging obstructive superficial femoral artery and popliteal artery disease.

Topics: Aged; Aged, 80 and over; Alloys; Angioplasty, Balloon; Anticoagulants; Blood Vessel Prosthesis; Coated Materials, Biocompatible; Constriction, Pathologic; Female; Femoral Artery; Heparin; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Peripheral Arterial Disease; Polytetrafluoroethylene; Popliteal Artery; Prosthesis Design; Recurrence; Retrospective Studies; Risk Factors; Stents; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Duplex; Vascular Patency

This study reports our experience during the first 50 cases of use of Supera stent for popliteal atherosclerotic lesions treatment.. This prospective single-arm trial enrolled the first 50 limbs (46 patients) treated in our center with a Supera stent for symptomatic atherosclerotic disease of the popliteal artery and a follow-up longer than 12 months.. Tissue loss (43.5%) was the most common primary indication for intervention, followed by claudication (37.0%) and rest pain (19.5%). Stent implantation was successful in all patients. The majority of lesions were Trans-Atlantic Inter-Society Consensus (TASC) II type D lesions (64%). The lesions treated were localized in P3 zone in 64%, P2 zone in 28%, and P1 zone in 8%. One runoff vessel was the most common situation (42%). Mean follow-up was 16.5 months (range 12-46). The mean preoperative ankle-brachial index increased from 0.38 + 0.37 before intervention to 0.63 + 0.86 postoperatively at 12 months (P = 0.014). Primary patency rates at 3, 6, 9, and 12 months were 95.9%, 91.7%, 89.6%, and 89.6%, and primary assisted patency rates were 95.9%, 93.8%, 93.8%, and 93.8%, respectively. In-stent restenosis was associated with the following: patient <75 years (P = 0.023), female sex (P = 0.032), and TASC-II D lesions (P = 0.041). Implantation defects did not constitute a risk factor for stent restenosis.. The implantation of the interwoven nitinol stents in patients with popliteal occlusive disease is safe and effective, with encouraging patency rates and clinical results after a 12-month follow-up. In our experience, we have not seen significant differences in patency at 1-year follow-up in patients with implantation defects.

Topics: Adult; Aged; Aged, 80 and over; Alloys; Angiography; Angioplasty, Balloon; Ankle Brachial Index; Constriction, Pathologic; Female; Humans; Intermittent Claudication; Male; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Prospective Studies; Prosthesis Design; Recurrence; Risk Factors; Spain; Stents; Time Factors; Treatment Outcome; Vascular Patency

The clinical outcomes of nitinol stents for femoropopliteal arterial (FP) disease in patients on hemodialysis were assessed. Endovascular therapy (EVT) is accepted for symptomatic FP disease. However, the clinical outcomes of patients on dialysis are not well known. A multicenter retrospective study was conducted with data between November 2010 and August 2013. A total of 484 consecutive patients who successfully underwent EVT for FP disease with nitinol stents were recruited and analyzed. Patients were categorized into the hemodialysis group (N = 161) and non-hemodialysis group (N = 323). The primary measure was primary patency verified by duplex ultrasound at a rest peak systolic velocity (PSVR) of >2.5, and secondary measures were freedom from target lesion revascularization (TLR) and major amputation-free survival (AFS). Average follow-up duration was 19.5 ± 13.5 months. The primary patency rate at 3 years was significantly lower in the hemodialysis group than the non-hemodialysis group (33.8 vs. 43.7 %; p = 0.036). Freedom from TLR at 3 years was 55.0 % in the hemodialysis group and 66.1 % in the non-hemodialysis group (p = 0.032). The hemodialysis group showed a significantly lower AFS rate at 3 years than the non-hemodialysis group (86.4 vs. 58.2 %; p < 0.001). In hemodialysis patients, nitinol stent use resulted in a lower patency rate, higher TLR rate, and lower AFS rate compared to non-hemodialysis patients. These data suggest that nitinol stent implantation for FP arteries in hemodialysis patient needs to be reconsidered.

Topics: Aged; Aged, 80 and over; Alloys; Amputation, Surgical; Constriction, Pathologic; Endovascular Procedures; Female; Femoral Artery; Humans; Japan; Kaplan-Meier Estimate; Limb Salvage; Male; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Prosthesis Design; Recurrence; Renal Dialysis; Renal Insufficiency, Chronic; Retrospective Studies; Risk Factors; Stents; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Duplex; Vascular Patency

To present a propensity score matching analysis comparing the 1-year outcomes of de novo femoropopliteal lesions treated with drug-eluting stents (DES) or bare nitinol stents (BNS).. A retrospective review was conducted of 452 limbs in 389 patients (mean age 74±8 years; 284 men) treated with DES implantation and 1808 limbs in 1441 patients (mean age 72±9 years; 1023 men) implanted with BNS for de novo femoropopliteal lesions. One-year follow-up data were available on all patients. The primary endpoint was 12-month restenosis assessed by duplex ultrasonography or follow-up angiography within ±2 months. Secondary endpoint was major adverse limb events (MALE) including major amputation, any reintervention, and restenosis.. The BNS group was more likely to have current smoking, chronic total occlusion, and poor below-the-knee runoff. The stratification analysis demonstrated that diabetes mellitus (DM) and reference vessel diameter (RVD) had a significant interaction on the association of DES vs BNS implantation with restenosis (interaction p<0.05). Thus, the population was stratified into 4 subgroups (1: -DM, RVD ≥5 mm, 2: +DM, RVD ≥5 mm, 3: -DM, RVD <5 mm, and 4: +DM, RVD <5 mm); the RVD threshold was empirically determined. There were no significant intergroup differences in baseline variables after matching. There was no significant difference in restenosis risk between DES and BNS in the RVD ≥5 mm subgroup regardless of the presence of DM. The DES group had a significantly higher restenosis risk in the RVD <5 mm subgroup regardless of the presence of DM. No significant difference was observed in the risk of major amputation, reintervention, or MALE in any subgroup.. These results suggest that a first-generation DES was not superior to a conventional BNS for femoropopliteal lesions.

Topics: Aged; Aged, 80 and over; Alloys; Amputation, Surgical; Constriction, Pathologic; Drug-Eluting Stents; Endovascular Procedures; Female; Femoral Artery; Humans; Japan; Limb Salvage; Male; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Propensity Score; Prosthesis Design; Recurrence; Registries; Retreatment; Retrospective Studies; Risk Factors; Stents; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Duplex; Vascular Patency

To describe and compare primary patency rates in patients undergoing endovascular femoropopliteal interventions with standard or interwoven nitinol stents or drug-coated balloons.. A cohort of 1292 patients was treated for symptomatic femoropopliteal occlusive disease classified as Rutherford category ≥ 1 at a large vascular center between June 2006 and August 2013 using either standard nitinol stents (SNS; n=432), interwoven nitinol stents (INS; n=470), or drug-coated balloons (DCB; n=390). Primary patency rates were assessed by ultrasound or angiographic readings for over 3 years of follow-up. Propensity score-matched pairs were formed to compare each treatment with another using survival analysis.. Survival curves of primary patency favored INS compared with SNS in 368 propensity score-matched pairs (p<0.001). Kaplan-Meier estimates at 1, 2, and 3 years were 86.6%, 76.4%, and 68.9%, respectively, in the INS group vs 60.5%, 46.1%, and 42.1%, respectively, in the SNS group. No significant difference (p=0.232) was seen for the comparison of SNS vs DCB in 284 matched pairs over long-term follow-up (primary patency estimates at 1, 2, and 3 years were 79.8%, 53.8%, and 32.9%, respectively, in the DCB group vs 60.5%, 44.8%, and 40.3%, respectively, in the SNS group). Survival curves of primary patency favored INS over DCB in 254 matched pairs (p<0.001). Kaplan-Meier estimates at 1, 2, and 3 years were 79.0%, 51.2%, and 30.1%, respectively, in the DCB group vs 89.0%, 76.9%, and 66.2%, respectively, in the INS group.. Propensity score-based analysis of primary patency suggests profound differences in restenosis rates between various treatment modalities for femoropopliteal disease for over 3 years of follow-up.

Topics: Aged; Alloys; Chi-Square Distribution; Coated Materials, Biocompatible; Constriction, Pathologic; Databases, Factual; Endovascular Procedures; Female; Femoral Artery; Germany; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Propensity Score; Proportional Hazards Models; Recurrence; Risk Factors; Stents; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency

To evaluate the safety and midterm patency of the Supera interwoven nitinol stent in a real-world population and determine deployment and patient-related factors that may predispose to loss of patency.. A retrospective analysis was conducted of 111 consecutive limbs from 97 patients (mean age 75.3 years; 68 men) with severe atherosclerotic disease of the superficial femoral and popliteal arteries that were treated with Supera stents between June 2012 and October 2014. Half the patients had claudication (56%); the remainder had rest pain (19%) and tissue loss (26%). Forty-eight (43%) lesions were chronic total occlusions, and more than half were classified as TransAtlantic Inter-Society Consensus C (22%) or D (30%).. All 146 Supera stents (1.32 stents per limb) were deployed successfully, extending over a mean length of 175.5±130.5 mm to treat lesions averaging 151.5±127.1 mm long. At 30 days, Kaplan-Meier estimated freedom from death, target lesion revascularization, and amputation was 97.3%. Primary patency and freedom from clinically driven target lesion revascularization rates were 87.1% and 95.0% at 6 months, respectively, and 78.9% and 87.6% at 12 months, respectively. Four distinct mechanisms for failure were identified in the 13 limbs in which patency was lost; stent intussusception (n=4), compromised inflow or outflow (n=2), gross oversizing (n=1), and neoplastic thrombophilia (n=1); the cause of 5 occlusions could not be identified.. In this heterogeneous group that included long and complex atheromatous femoropopliteal lesions, the Supera stent achieved excellent clinical and patency results at 1 year. Further improvement may be achieved through careful patient selection and the avoidance of deployment pitfalls.

Topics: Adult; Aged; Aged, 80 and over; Alloys; Amputation, Surgical; Angiography, Digital Subtraction; Constriction, Pathologic; Disease-Free Survival; Endovascular Procedures; Female; Femoral Artery; Humans; Intermittent Claudication; Kaplan-Meier Estimate; Limb Salvage; Male; Middle Aged; New South Wales; Peripheral Arterial Disease; Popliteal Artery; Prosthesis Design; Retrospective Studies; Risk Factors; Stents; Time Factors; Treatment Failure; Vascular Patency

To compare optimal balloon angioplasty with nitinol stenting and drug-eluting stent (DES) implantation for femoropopliteal in-stent occlusion (ISO).. A dual center, retrospective study was performed from January 2004 to December 2014 encompassing 110 ISOs after bare nitinol stenting for a femoropopliteal lesion in 100 patients (mean age 72.7±10.1 years; 58 men). These patients underwent optimal balloon angioplasty with implantation of a bare stent (conventional group, n=79) or a DES (n=21). The primary endpoint was recurrent in-stent restenosis (Re-ISR); secondary endpoints were recurrent target lesion revascularization (Re-TLR), reocclusion, and major adverse limb events (MALE). Re-ISR or reocclusion was defined as ISR or occlusion after TLR. Restenosis was defined as a peak systolic velocity ratio >2.4 on a duplex scan or >50% stenosis on angiography. Univariate Cox regression analysis was used to identify any relationships between patient and procedure variables and the occurrence of Re-ISR; the results are presented as the hazard ratio (HR) and the 95% confidence interval (CI).. The mean follow-up period was 34.9±27.4 months. At 2 years, Kaplan-Meier estimated freedom from Re-ISR rates were 79.3% in the DES group and 20.2% in the conventional group, respectively (p<0.001). The rates of freedom from Re-TLR, reocclusion, and MALE at 2 years were 85.7%, 85.9%, and 85.7% in the DES group and 27.1%, 42.5%, and 25.3% in the conventional group, respectively (p<0.001, p=0.006, and p<0.001, respectively). Univariate analysis showed only postprocedure stenosis (HR 1.04, 95% CI 1.02 to 1.07, p<0.001) as a predictor of Re-ISR. Postprocedure ABI (HR 0.06, 95% CI 0.01 to 0.30, p<0.001) and DES use (HR 0.20, 95% CI 0.07 to 0.44, p<0.001) were associated with a lower likelihood of developing Re-ISR.. In this small comparative study, DES stent implantation gives more favorable outcomes than conventional treatment for ISO after femoropopliteal stenting.

Topics: Aged; Aged, 80 and over; Alloys; Angioplasty, Balloon; Chi-Square Distribution; Constriction, Pathologic; Databases, Factual; Disease-Free Survival; Drug-Eluting Stents; Female; Femoral Artery; Humans; Japan; Kaplan-Meier Estimate; Male; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Proportional Hazards Models; Prosthesis Design; Recurrence; Retreatment; Retrospective Studies; Risk Factors; Stents; Time Factors; Treatment Outcome

To identify intravascular ultrasound (IVUS) measurements that can predict angiographic in-stent restenosis (ISR) following nitinol stent implantation in superficial femoral artery (SFA) lesions.. A retrospective review was conducted of 97 patients (mean age 72.9±8.9 years; 63 men) who underwent IVUS examination during endovascular treatment of 112 de novo SFA lesions between July 2012 and December 2014. Self-expanding bare stents were implanted in 46 lesions and paclitaxel-eluting stents in 39 lesions. Six months after stenting, follow-up angiography was conducted to assess stent patency. The primary endpoint was angiographic ISR determined by quantitative vascular angiography analysis at the 6-month follow-up. Variables associated with restenosis were sought in multivariate analysis; the results are presented as the odds ratio (OR) and 95% confidence interval (CI).. At follow-up, 27 (31.8%) angiographic ISR lesions were recorded. The lesions treated with uncoated stents were more prevalent in the ISR group compared with the no restenosis group (74.1% vs 44.8%, p=0.02). Lesion length was longer (154.4±79.5 vs 109.0±89.3 mm, p=0.03) and postprocedure minimum stent area (MSA) measured by IVUS was smaller (13.9±2.8 vs 16.3±1.6 mm(2), p<0.001) in the ISR group. Multivariate analysis revealed that bare stent use (OR 7.11, 95% CI 1.70 to 29.80, p<0.01) and longer lesion length (OR 1.08, 95% CI 1.01 to 1.16, p=0.04) were predictors of ISR, while increasing postprocedure MSA (OR 0.58, 95% CI 0.41 to 0.82, p<0.01) was associated with lower risk of ISR. Receiver operating characteristic analysis identified a MSA of 15.5 mm(2) as the optimal cutpoint below which the incidence of restenosis increased (area under the curve 0.769).. Postprocedure MSA can predict ISR in SFA lesions, which suggests that adequate stent enlargement during angioplasty might be required for superior patency.

Topics: Aged; Aged, 80 and over; Alloys; Angiography; Angioplasty, Balloon; Area Under Curve; Cardiovascular Agents; Chi-Square Distribution; Constriction, Pathologic; Drug-Eluting Stents; Female; Femoral Artery; Humans; Logistic Models; Male; Middle Aged; Multivariate Analysis; Odds Ratio; Paclitaxel; Peripheral Arterial Disease; Predictive Value of Tests; Prosthesis Design; Recurrence; Retrospective Studies; Risk Factors; ROC Curve; Stents; Time Factors; Treatment Outcome; Ultrasonography, Interventional; Vascular Patency

Peripheral vascular disease (PVD) is a devastating medical problem that may lead to significant life alterations for patients, from simply limiting their daily activities to potential loss of limbs and eventual demise. Superficial femoral and popliteal arteries are significantly common locations for PVD sequelae to present itself, and owing to their length and mobile nature, treatment of these segments are quite challenging. Indications for PVD treatment include lifestyle-limiting claudication that is not responding to medical management, ischemic rest pain, nonhealing ulcers, and lower extremity gangrene. There is a wide variety of treatment options that include medical management, interventional, and surgical techniques. Interventional techniques include plain old balloon angioplasty, cryoplasty, drug-coated balloon angioplasty, self-expanding bare-nitinol stents, self-expanding covered stents, self-expanding drug-eluding stents, and a number of atherectomy devices (ie, laser, rotational, orbital, and excisional). The scope of this article is to review indications, patient selection, and deployment techniques of Viabahn and Supera self-expanding stents.

Topics: Aged; Aged, 80 and over; Alloys; Angiography, Digital Subtraction; Anticoagulants; Blood Vessel Prosthesis; Endovascular Procedures; Female; Femoral Artery; Humans; Male; Metals; Middle Aged; Patient Selection; Peripheral Arterial Disease; Popliteal Artery; Prosthesis Design; Risk Factors; Stents; Treatment Outcome; Vascular Patency

The structural limitations of currently available laser-cut nitinol stents in the highly diseased arterial system of the lower extremity are well described. These devices are frequently used in long-segment occlusions, at the adductor hiatus, and across the knee into the popliteal artery and tibial-peroneal trunk despite concerns related to the high mobility of the knee joint and the potential for external stent compression, fractures, and occlusion. The Supera stent (Abbott Vascular, Santa Clara, Calif) was developed to provide superior radial strength, fracture resistance, and flexibility compared with laser-cut nitinol stents. This study represents the initial U.S. experience in the management of lower extremity artery atherosclerotic disease with the Supera interwoven wire stent.. Patients undergoing stent implantation in the 20-month period after the 2008 Food and Drug Administration clearance were included. Medical records, radiographic imaging, and procedural data were examined. Procedural angiograms were classified according to TransAtlantic Inter-Society Consensus criteria. Patency and limb loss rates were calculated using Kaplan-Meier analysis.. There were 305 stents implanted in 147 patients. Clinical follow-up was a mean of 12.7 months (range, 0.2-33.7 months), and radiologic follow-up was a mean of 8.4 months (range, 0.2-26.8 months). Most patients had critical limb ischemia, with tissue loss (38.1%) or rest pain (28.6%) as the indication for intervention. Of the 147 patients, 75 (51.02%) underwent a concomitant adjunctive procedure in the treated extremity. Primary, assisted primary, and secondary patency rates at 12 months by duplex ultrasound imaging were 89.8%, 91.2%, and 93.2%, respectively, by Kaplan-Meier estimates, with a mean lesion length of 184.5 ± 131.80 mm and mean stented length of 197.5 ± 113.65 mm. Seventeen patients experienced an event requiring successful reintervention in the stented segment (13 for type I or II restenosis; four for type III). There were eight major amputations, with five of those eight having a patent stent at the time of limb sacrifice. The overall mortality was 11.6% during the study period. Knee radiography was performed in 47 patients with devices extending into the popliteal and tibial-peroneal segment, and no stent fractures were identified.. Stenting of the superficial femoral and popliteal arteries using the Supera stent system appears to be safe and effective. The interwoven stent design may better serve areas under extreme mechanical stress. Our results with this population of highly diseased patients including very long lesion lengths are consistent with outcomes of other publications reporting the use of this device.

Topics: Aged; Aged, 80 and over; Alloys; Amputation, Surgical; Arizona; Critical Illness; Endovascular Procedures; Female; Femoral Artery; Humans; Intermittent Claudication; Ischemia; Kaplan-Meier Estimate; Limb Salvage; Male; Middle Aged; Multivariate Analysis; Peripheral Arterial Disease; Popliteal Artery; Proportional Hazards Models; Prospective Studies; Prosthesis Design; Registries; Retreatment; Risk Factors; Stents; Time Factors; Treatment Outcome; Vascular Patency

Topics: Aged; Alloys; Angiography; Angioplasty; Constriction, Pathologic; Femoral Artery; Humans; Male; Peripheral Arterial Disease; Prosthesis Design; Prosthesis Failure; Recurrence; Self Expandable Metallic Stents; Treatment Outcome; Ultrasonography, Doppler, Duplex; Vascular Patency

To determine whether statin therapy is associated with reduced restenosis following nitinol stent implantation for de novo femoropopliteal artery disease.. A total of 135 limbs in 135 patients (mean age, 72 y) implanted with nitinol stents in femoropopliteal occlusions were analyzed (statin arm, n = 91; nonstatin arm, n = 44). The patients were treated with one type of nitinol stent.. At baseline, lesions and procedural characteristics were comparable between groups, except that the statin group had more hypertension, coronary artery disease, and hyperlipidemia. There were significant differences in the incidence of binary restenosis between groups at 1 year (45.5% for nonstatin group vs 28.6% for statin group; P = .05) and 2 years (56.8% for nonstatin group vs 38.5% for statin group; P = .04). Primary patency rates at 1 year were 50.5% in the nonstatin group and 72.5% in the statin group (P = .01). Two-year target lesion revascularization rates were 54.5% in the nonstatin group and 35.2% in the statin group (P = .03). On univariate analysis, statin therapy was associated with decreased relative risk of binary restenosis at 1 year (odds ratio [OR], 0.480; 95% confidence interval [CI], 0.227-1.014; P = .050). On multivariate analysis, statin therapy did not significantly affect the odds of binary restenosis (OR, 0.415; 95% CI, 0.071-2.437; P = .330).. The incidence of binary restenosis was significantly lower in the statin group than in the nonstatin group following nitinol stent implantation for de novo femoropopliteal artery disease.

Topics: Aged; Aged, 80 and over; Alloys; Endovascular Procedures; Female; Femoral Artery; Florida; Follow-Up Studies; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Logistic Models; Male; Middle Aged; Multivariate Analysis; Odds Ratio; Peripheral Arterial Disease; Popliteal Artery; Prosthesis Design; Protective Factors; Recurrence; Retrospective Studies; Risk Factors; Stents; Time Factors; Treatment Outcome; Vascular Patency

To evaluate the safety and efficacy of a self-expanding bare-metal nitinol stent (Astron; BIOTRONIK AG, Bülach, Switzerland) for the treatment of atherosclerotic lesions in the common and external iliac arteries. This study tested the hypothesis that the major adverse event (MAE) rate at 12 months was less than or equal to a performance goal of 15%.. In a prospective study that began in November 2011, 161 patients with symptomatic iliac lesions were treated with an Astron stent in the United States, Canada, and Austria. The primary endpoint was a composite rate of procedure- and stent-related MAEs at 12 months that included 30-day mortality, clinically indicated target lesion revascularization (TLR), and index limb amputation.. The MAE rate at 12 months was 2.1% (3/146; [95% CI: 0.4% to 5.9%]; p < 0.001). The acute procedural success and 30-day clinical success outcomes were both 95% (153/161). The primary patency rate at 12 months was 89.8% (115/128). The comparison of baseline and 12-month Ankle Brachial Index (ABI) measurements showed a mean increase of 0.23 ± 0.19 (p < 0.001). The Walking Impairment Questionnaire (WIQ) PAD specific score, walking distance score, walking speed score and stair climbing score paired each showed a significant increase from baseline to 12 months (p<0.001).. The Astron stent system was shown to be safe and effective in the treatment of patients with atherosclerotic disease. The observed MAE rate met the pre-specified performance goal of 15%. The stent demonstrated a high 12-month primary patency rate and showed improvement in quality of life measures.

Topics: Aged; Alloys; Ankle Brachial Index; Austria; Canada; Constriction, Pathologic; Endovascular Procedures; Exercise Test; Exercise Tolerance; Female; Humans; Iliac Artery; Intermittent Claudication; Limb Salvage; Male; Middle Aged; Peripheral Arterial Disease; Prospective Studies; Prosthesis Design; Quality of Life; Recovery of Function; Registries; Self Expandable Metallic Stents; Surveys and Questionnaires; Time Factors; Treatment Outcome; United States; Vascular Patency; Walking

To compare primary patency between MISAGO (Terumo Corporation, Tokyo, Japan) and S.M.A.R.T. CONTROL (Cordis Corporation, Miami Lakes, Florida), second-generation and first-generation nitinol stents, in femoropopliteal lesions.. This multicenter, retrospective study included 240 cases with MISAGO stent implantation and 1,265 cases with S.M.A.R.T. stent implantation. The S.M.A.R.T. group had more Trans-Atlantic Inter-Society of Consensus (TASC) II class C/D lesions (53% vs 41%, P = .001) and smaller reference vessel diameter (RVD) (5.3 mm ± 0.9 vs 5.5 mm ± 0.9, P < .001).. Kaplan-Meier estimates of 2-year primary patency after S.M.A.R.T. and MISAGO stent implantation were 67% and 55% (P = .007). Interaction analysis revealed that TASC II classification and RVD had a significant influence on the association of MISAGO versus S.M.A.R.T. stents with the outcome. The study population was stratified according to TASC II classification and RVD, and MISAGO and S.M.A.R.T. stents were compared after propensity score matching. There was no significant difference in 2-year patency between the 2 stents in the subgroup with TASC II class A/B and RVD ≥ 5 mm (S.M.A.R.T. 82% ± 4 vs MISAGO 74% ± 5, P = .480). MISAGO stents had lower primary patency than S.M.A.R.T. stents in cases with TASC II class C/D or RVD < 5 mm (S.M.A.R.T. 62% ± 6 vs MISAGO 25% ± 6, P = .015).. S.M.A.R.T. and MISAGO stents had similar patency in simple lesions, but MISAGO stents had lower patency than S.M.A.R.T. stents in more complex lesions.

Topics: Aged; Aged, 80 and over; Alloys; Constriction, Pathologic; Endovascular Procedures; Female; Femoral Artery; Humans; Japan; Kaplan-Meier Estimate; Logistic Models; Male; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Propensity Score; Proportional Hazards Models; Prosthesis Design; Prosthesis Failure; Recurrence; Retrospective Studies; Self Expandable Metallic Stents; Time Factors; Treatment Outcome; Vascular Patency

To quantify the deformation behavior of the diseased femoropopliteal segment and assess the change to deformation behavior due to various stent placements.. The length and curvature changes of 6 femoropopliteal segments (the right and left superficial femoral and popliteal arteries) from 3 cadavers were measured in 3-dimensional space based on rotational angiography image data in straight leg and flexed hip/knee (50°/90°) positions before and after placement of nitinol stents of varying type (EverFlex, Misago, and BioMimics 3D) and length (60, 100, and 200 mm) in different locations along the arteries. Three-dimensional centerline data were extracted for the measurements.. All 6 femoropopliteal cadaver segments displayed signs of peripheral artery disease. Hip/knee flexion resulted in vessel shortening and increases in the mean and maximum vessel curvatures in all cases. Location-specific results of the unstented arteries showed that magnitudes of vessel length and curvature change vary as a function of vessel length. The average shortening of the entire femoropopliteal segment due to flexion was observed at 10.7%±0.7%, which was reduced to 8.1%±0.9% after stent deployment. Average and maximum curvatures of the unstented segment increased due to flexion (average: 0.008±0.002 mm. The deformation characteristics of the femoropopliteal segment change in the presence of a stent, with the change to the deformation behavior dependent on stent type, stent length, location, flexibility, and intrinsic centerline curvature.

Topics: Aged; Alloys; Biomechanical Phenomena; Cadaver; Computed Tomography Angiography; Endovascular Procedures; Female; Femoral Artery; Hip Joint; Humans; Knee Joint; Male; Peripheral Arterial Disease; Pliability; Popliteal Artery; Posture; Prosthesis Design; Range of Motion, Articular; Stents

Topics: Aged; Alloys; Computed Tomography Angiography; Endovascular Procedures; Humans; Iliac Aneurysm; Iliac Artery; Male; Peripheral Arterial Disease; Prosthesis Design; Prosthesis Failure; Risk Factors; Stents; Time Factors

Recanalization of long segmental occlusions of femoropopliteal arteries can be achieved by angioplasty and implantation of nitinol stents with high procedural success rates. However, due to recurrent in-stent restenoses (ISR) some patients need repeated interventions and their intermediate success rates are uncertain.. Patients who were treated in our center from March 2008 through February 2011 due to symptomatic ISR (as determined by Duplex sonography) were retrospectively included in the study. After endovascular treatment of their ISR, they were prospectively evaluated with regard to recurrent ISR of the target lesions.. A total of 36 limbs (=lesions) in 32 patients (69% male, mean age 69±9 years) were successfully treated by balloon-angioplasty. Adjunctive cutting balloons and drug eluting balloons were used in 78% and 8%, respectively. Mean follow-up was 326 days. Recurrent ISR occurred in 10 (28%) lesions, while 26 (78%) lesions showed no recurrence of ISR. In a multivariate logistic regression analysis, age, gender, cardiovascular risk factors, renal failure and medication with cilostazol were not significantly associated with recurrent ISR. Moreover, the number of previous interventions of the target lesions was not an independent predictor of recurrent ISR.. Patients with multiple recurrences of ISR seem to have the same prospects of acute and mid-term success for endovascular treatment as those with first presentation of ISR. However, this observation has to be confirmed by prospective, large scale studies with a longer follow-up period to determine the significance of endovascular intervention within the scope of different revascularization approaches for treatment of recurrent ISR.

Topics: Aged; Alloys; Angioplasty, Balloon; Constriction, Pathologic; Drug-Eluting Stents; Female; Femoral Artery; Humans; Logistic Models; Lower Extremity; Male; Middle Aged; Multivariate Analysis; Peripheral Arterial Disease; Popliteal Artery; Recurrence; Retrospective Studies; Risk Factors; Vascular Patency

Arterial repair differences between paclitaxel-coated nitinol drug-eluting stent (DES) vs. bare-metal stent (BMS) up to 1 year after implantation in the superficial femoral artery (SFA) have not been well characterized. We compared angioscopic findings 1 year after implantation in the SFA of 22 DES in 18 patients and 12 BMS in 9 patients (follow-up period 354 ± 49 vs. 383 ± 81 days, P = 0.20). Neointimal coverage (NIC) was graded as: 0, stent struts exposed; 1, struts bulged into the lumen, although covered; 2, struts embedded by the neointima, but translucent; and 3, struts fully embedded and invisible. NIC was defined as heterogeneous when NIC grade variation was ≥1. Presence of thrombus and yellow plaques (YP) was assessed. Baseline patient and lesion characteristics were similar between the groups. In terms of procedural characteristics, stent diameter was smaller in DES than in BMS (6.5 ± 0.5 vs. 7.4 ± 0.8 mm, P = 0.0020). Both DES (grade 2 5 %, grade 3 95 %) and BMS (grade 3 100 %) revealed dominant NIC grades of 2 or 3 (P = 0.46), however, DES showed greater NIC heterogeneity than BMS (91 vs. 42 %, P = 0.004). Both thrombus and YP were more frequently observed in DES than in BMS (64 vs. 17 %, P = 0.001; 95 vs. 67 %, P = 0.042, respectively). In conclusion, although arterial repair was limited after DES implantation in the SFA, it was extensive at 1 year.

Topics: Aged; Aged, 80 and over; Alloys; Angiography; Angioscopy; Drug-Eluting Stents; Female; Femoral Artery; Follow-Up Studies; Humans; Male; Metals; Middle Aged; Paclitaxel; Peripheral Arterial Disease; Stents

Access site problems often cause serious complications in endovascular treatment. The aim of this study is to investigate whether a sheath-less nitinol stenting technique leads to reduce access site complications. This study was a single-center retrospective analysis of a prospectively maintained database. The study enrolled consecutive 98 patients with 111 lesions undergoing provisional stenting for de novo iliac artery or femoro-popliteal artery stenosis between August 2010 and November 2011. The patients were divided into two groups, a conventional procedure group and a sheath-less procedure group. The outcomes of this study were peri-procedural access site complications, initial success rate, procedure time, hemostatic time and bed-rest time. Forty-four lesions in 39 patients that treated using the sheath-less nitinol stent delivery technique were compared with 67 lesions in 59 patients treated using the conventional procedure. All procedures were successful. The incidence of pseudoaneurysm was significantly lower in the sheath-less procedure group than in the conventional procedure group (p = 0.043). However, there were no significant differences in any other complications. No significant difference was observed in the procedural time (p = 0.309). However, hemostatic time and bed-rest time were significantly shorter in the sheath-less procedure than in the conventional procedure (p < 0.0001). A sheath-less stenting technique reduced the access site incidence of pseudoaneurysm and did not increase other access site complications. Besides, this technique shortened hemostatic time and bed-rest time. The sheath-less stenting technique is considered to be a useful method for endovascular treatment.

Topics: Aged; Aged, 80 and over; Alloys; Angioplasty, Balloon; Endovascular Procedures; Female; Femoral Artery; Humans; Iliac Artery; Male; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Retrospective Studies; Stents

Efficacy of endovascular therapy (EVT) with nitinol stents for femoropopliteal (FP) lesions is limited by restenosis. Oral cilostazol reduces angiographic restenosis rate; however, treatment duration remains unclear. In a retrospective analysis of a multicenter database of 3471 consecutive limbs in 2737 patients (mean age: 72 ± 9 years; 61% diabetic; and 26% on regular dialysis) undergoing EVT for FP lesions between January 2004 and December 2011, we compared Kaplan-Meier estimated primary patency after EVT followed or not by cilostazol treatment. We used Cox hazard regression analysis to assess temporal association between cilostazol treatment and post-EVT restenosis. Five-year primary patency was higher in the cilostazol group than in the noncilostazol group (57% vs 47%, P < .0001). Cilostazol treatment was inversely associated with restenosis for the first 2 years following EVT (P < .05); however, no significant association was observed thereafter. Cilostazol use therefore appears efficacious in preventing restenosis up to 2 years after EVT for FP lesions.

Topics: Administration, Oral; Aged; Aged, 80 and over; Alloys; Cardiovascular Agents; Cilostazol; Databases, Factual; Endovascular Procedures; Female; Humans; Japan; Kaplan-Meier Estimate; Male; Middle Aged; Peripheral Arterial Disease; Proportional Hazards Models; Prosthesis Design; Recurrence; Retrospective Studies; Risk Factors; Stents; Tetrazoles; Time Factors; Treatment Outcome; Vascular Patency

The aim of this paper was to report the continued mid-term follow-up of the first patients world-wide treated with the GORE(®) TIGRIS(®) Vascular Stent, a dual component stent consisting of a nitinol wire frame combined with a fluoropolymer-interconnecting structure.. From December 2011 until November 2012, 32 consecutive patients (20 men, mean age 72.8 years) with 40 atherosclerotic femoropopliteal lesions (5% occlusions) underwent angioplasty and implantation of a GORE(®) TIGRIS(®) Vascular Stent. The patients were scheduled for follow-up at 3, 6 and 12 months after stent implantation for duplex ultrasound and assessment of Rutherford-Becker class (RBC) and Ankle-Brachial Index (ABI). Here we report the completed 6-month follow-up and, for the first time, a 12-month follow-up.. The median follow-up was 418 days. During the 12-month follow-up 4 patients died. Restenosis or reocclusion of the stent in this time period was observed in 5 lesions (12.5%), resulting in a cumulative primary patency rate of 85.5±6.0%. The ABI increased pre-interventionally from 0.65±0.18 to 0.91±0.18 (P<0.0001) at the 12-month visit. The median RBC improved from 3 to 1 (P<0.0001). No stent thrombosis related to discontinuation of dual antiplatelet therapy 4 weeks after the index procedure was observed.. The mid-term follow-up of the dual component GORE(®) TIGRIS(®) Vascular Stent showed promising results with high 12-month primary patency rates after femoropopliteal endovascular interventions. These first clinical data are very promising compared to other stent concepts in the superficial femoral and popliteal artery.

Topics: Aged; Aged, 80 and over; Alloys; Angiography, Digital Subtraction; Angioplasty; Ankle Brachial Index; Constriction, Pathologic; Drug Administration Schedule; Drug Therapy, Combination; Female; Femoral Artery; Humans; Male; Middle Aged; Peripheral Arterial Disease; Platelet Aggregation Inhibitors; Popliteal Artery; Prosthesis Design; Recurrence; Retrospective Studies; Stents; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Duplex; Vascular Patency

The Supera stent (Abbott Laboratories, Abbott Park, Ill) has a unique biomimetic design allowing axial and longitudinal flexibility and fracture resistance. The aim of this retrospective study was to assess the midterm patency of Supera stents used to treat patients with superficial femoral and popliteal arterial disease by a single practice.. From April 2010 to December 2011, 53 patients and 59 limbs with symptomatic femoropopliteal lesions underwent angioplasty and stenting with the Supera stent. Five patients had no follow-up and were excluded. Demographics of the patients, radiographic images, morphologic features of the lesions, procedural reports, reinterventions, and follow-up clinical visit notes were reviewed. Primary patency was defined as clinical resolution of symptoms with no secondary interventions. Primary and secondary patency rates at 12, 24, and 36 months were estimated by Kaplan-Meier analysis.. A total of 48 patients (42 men, six women; 54 limbs; mean age, 64.3 years [range, 51-87]) received Supera stents and had at least one follow-up visit as part of their treatment for femoropopliteal disease. Primary indications for intervention included claudication, rest pain, and tissue loss, at rates of 54% (29 of 54), 26% (14 of 54), and 20% (11 of 54), respectively; 22% of lesions were TransAtlantic Inter-Society Consensus type A or B and 78% were type C or D. Mean lesion length was 24.0 cm (range, 3-51). Mean follow-up was 27.5 months (range, 1-45). The ankle-brachial index increased from 0.58 ± 0.20 preoperatively to 0.77 ± 0.18 postoperatively (P = .00004). Primary, primary assisted, and secondary patency rates at latest follow-up were 79.6%, 88.9%, and 92.3%, respectively. Cumulative primary patency rates by Kaplan-Meier analysis at 12, 24, and 36 months were 85.6%, 83.1%, and 76.7%, respectively. Secondary patency rates by Kaplan-Meier estimates at 12, 24, and 36 months were 93.8%, 93.8%, and 89.3%, respectively. No stent fractures were found at the time of any reinterventions. Long lesions >30 cm (n = 18) showed equivalent patency to lesions of 1 to 15 cm (n = 18) and lesions 15 to 30 cm in length (n = 18).. Our midterm results show that Supera stents are durable in treating femoropopliteal lesions, with notably high patency rates in patients with long lesion lengths.

Topics: Aged; Aged, 80 and over; Alloys; Angioplasty; Chi-Square Distribution; Constriction, Pathologic; Female; Femoral Artery; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Missouri; Peripheral Arterial Disease; Popliteal Artery; Postoperative Complications; Prosthesis Design; Retreatment; Retrospective Studies; Stents; Time Factors; Treatment Outcome; Vascular Patency

To compare the vascular response after paclitaxel-coated nitinol drug-eluting stent (Zilver PTX) implantation for superficial femoral artery lesions after 6 and 12 months using optical coherence tomography (OCT).. Serial OCT examinations were performed in 5 patients (4 men; mean age 78.4 ± 6.8 years) with 9 Zilver PTX stents at 6- and 12-month follow-up. Variables evaluated included neointimal thickness and apposition on each strut, the incidence of extrastent lumen (ESL), peristrut low-intensity area (PLIA), and neovascularization at 1-mm intervals.. A total of 249 matched cross-section images were evaluated and included 4788 and 4826 struts at 6 and 12 months, respectively. Mean neointimal thickness significantly increased from 480 to 540 µm between 6 and 12 months (p < 0.001). The percentage of uncovered struts tended to decrease at 12 months (3% vs. 2.3%, p = 0.054), whereas the percentage of malapposed struts were similar at both examinations (0.2% vs. 0.2%, p > 0.99). Although the incidence of ESL in cross sections was not different (35% vs. 31%, p = 0.29), median ESL area significantly increased from 6 to 12 months [0.12 (0.04-0.36) vs. 0.31 (0.14-0.59) mm(2), p = 0.003)]. The presence of PLIA (29% vs. 44%, p < 0.001) and neovascularization (14% vs. 27%, p < 0.001) increased from 6 to 12 months.. These findings suggest that delayed vascular healing and persistent peristent inflammation may be present even at 12 months after Zilver PTX implantation.

Topics: Aged; Aged, 80 and over; Alloys; Cardiovascular Agents; Drug-Eluting Stents; Female; Femoral Artery; Follow-Up Studies; Humans; Male; Neointima; Paclitaxel; Peripheral Arterial Disease; Predictive Value of Tests; Retrospective Studies; Risk Factors; Sensitivity and Specificity; Tomography, Optical Coherence; Treatment Outcome

The femoropopliteal arteries are subjected to considerable axial and bending deformity due to flexion at the hip and knee joints. The Supera helical interwoven nitinol stent system (IDEV Technologies, Inc/Abbott Laboratories, Inc, Webster, Tex) has good conformability and flexibility, with a very low incidence of mechanical fatigue. This study reviewed our experience with the use of Supera stents for femoropopliteal atherosclerotic lesions and identified risk factors for restenosis or occlusion.. Patients with symptomatic femoropopliteal atherosclerotic diseases who underwent lower limb angioplasty and Supera stent insertion were studied. All patients had regular clinical follow-up and underwent a Doppler ultrasound examination at 3 months and then every 6 months, and radiography of the stents at 6, 12, 18, 24, 30, and 36 months. Patency rates were analyzed using Kaplan-Meier curves. We also evaluated the prospectively maintained cohort to identify predictors of restenosis.. From October 2011 to December 2014, 164 legs in 153 symptomatic patients (96 male, 57 female) with femoropopliteal occlusive disease, with mean age of 76.7 years (range, 46-100 years), were included. Ninety-five patients (58%) had claudication, nine (5%) had rest pain, and 60 (37%) had tissue loss. Disease distribution was 64 proximal superficial femoral arteries (SFAs; 39%), 107 middle SFAs (65%), 127 distal SFAs (77%), 78 above-knee popliteal arteries (48%), and 19 below-knee popliteal arteries (12%). Lesion classification by TransAtlantic Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II) A, B, C, and D was 49 (30%), 79 (48%), 31 (19%), 3 (1%), respectively. The mean lesion length was 105.6 mm (range, 3-400 mm), and more than one Supera stent was inserted in 26 patients. Procedure success (residual stenosis <30%) was achieved in 100% of procedures. The primary patency rates (>50% patency) at 6, 12, 24, and 30 months were (±standard error) 86.7% ± 3.1%, 81.4% ± 3.7%, 79.9% ± 4.0%, and 77 ± 3.0%, respectively. The ankle-brachial pressure index increased from 0.57 ± 0.15 preoperatively to 0.87 ± 0.14 postoperatively. No stent fractures occurred. There were three 30-day deaths not related to the procedure or device, one major amputation 3 months after revascularization, and 29 late deaths (>30 days) of unrelated medical causes in follow-up. In-stent restenosis was associated with younger patient age and with dyslipidemia, long lesion, and stent length.. Our midterm experience showed that the implantation of the helical interwoven nitinol stents in patients with femoropopliteal occlusive disease is safe and effective, with encouraging patency rates and clinical results.

Topics: Aged; Aged, 80 and over; Alloys; Angioplasty; Chi-Square Distribution; Constriction, Pathologic; Female; Femoral Artery; Hong Kong; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Prosthesis Design; Radiography; Recurrence; Risk Factors; Stents; Time Factors; Treatment Outcome; Ultrasonography, Doppler; Vascular Patency

To evaluate the relationship between 1-year primary patency and lesion length in patients with femoropopliteal disease treated with bare nitinol stents.. The study was a retrospective analysis of a prospectively maintained multicenter database. Between January 2004 and December 2011, 1047 consecutive patients (mean age 72 years; 765 men) underwent femoropopliteal stenting with nitinol stents in 1373 limbs. The mean vessel diameter was 5.3±0.7 mm and the mean lesion length was 142±75 mm. One-year follow-up data were collected and analyzed to ascertain which lesion length would be expected to demonstrate a 1-year primary patency above the established 66% objective performance goal (OPG).. The lower limit of the 95% confidence interval (CI) for the unadjusted 1-year primary patency was >66% when the lesion length was ≤243 mm. After adjustment of the covariates to match those of the OPG-derived population, the 1-year primary patency decreased linearly with longer lesion length. The 1-year primary patency was 83.2% (95% CI 79.8% to 86.1%) for a 100-mm lesion length, 76.4% (95% CI 71.7% to 80.5%) for a 200-mm lesion length, and 70.7% (95% CI 62.4% to 77.7%) for a 300-mm lesion length. The maximum lesion length providing a 1-year primary patency significantly greater than 66% was calculated to be 263 mm.. The 1-year primary patency of femoropopliteal lesions treated with bare nitinol stents decreased linearly with longer lesion length. The maximum lesion length providing a higher patency rate than the OPG of 66% was ~25 cm.

Topics: Aged; Alloys; Atherosclerosis; Endovascular Procedures; Female; Femoral Artery; Humans; Male; Peripheral Arterial Disease; Popliteal Artery; Prosthesis Design; Retrospective Studies; Stents; Vascular Patency

Topics: Alloys; Endovascular Procedures; Femoral Artery; Humans; Peripheral Arterial Disease; Popliteal Artery; Stents

Widespread use of self-expanding nitinol stent-based endovascular treatment (EVT) for femoropopliteal (FP) lesions has been fueled by its less-invasive nature and modest durability; however, prevalence, predictors and prognosis of in-stent occlusion are undefined and were investigated here.. This study entailed a multicenter, retrospective analysis of a prospectively maintained database. Between January 2004 and December 2011, 2447 de novo FP lesions (mean length, 143 ± 87 mm; 52% chronic total occlusions) from 2008 patients (mean age, 73.0 ± 9.2 years; 71% male; 61% diabetics; 32% critical limb ischemia; and 24% on hemodialysis) were treated with nitinol stent-based EVT. Study outcome was in-stent occlusion: rates (1, 3, and 5 years), predictors and association with limb prognosis.. In-stent occlusion rate was 5.2%, 11.2%, and 16.4% at 1, 3, and 5 years, respectively (mean follow-up, 2.3 ± 1.7 years). Female sex, critical limb ischemia, and Transatlantic Inter-Society Consensus II class C/D (multivariate Cox proportional hazard ratio [HR], 1.75, 1.49, and 3.34, respectively) were independent predictors of in-stent occlusion after FP stenting, which was associated with poor limb prognosis (major amputation, HR 6.35; major adverse limb event, major adverse limb event, HR, 21.1).. Moderate in-stent occlusion rates were observed after nitinol stent-based EVT. Closer attention is warranted with high-risk cases because of poorer limb prognosis.

Topics: Aged; Aged, 80 and over; Alloys; Constriction, Pathologic; Endovascular Procedures; Female; Femoral Artery; Humans; Incidence; Japan; Kaplan-Meier Estimate; Male; Middle Aged; Multicenter Studies as Topic; Multivariate Analysis; Peripheral Arterial Disease; Popliteal Artery; Proportional Hazards Models; Prosthesis Design; Recurrence; Registries; Retrospective Studies; Risk Factors; Stents; Time Factors; Treatment Outcome

The Supera helical interwoven nitinol stent has enhanced flexibility in counteracting fractures when placed in the femoropopliteal arteries and may improve patency. The aim of this study is to assess the early results of the Supera stent in symptomatic patients with femoropopliteal atherosclerotic lesions.. From October 2011 to April 2013, patients with symptomatic femoropopliteal lesions were treated with angioplasty and primary stenting using the Supera stent. They were followed up at 1, 3, 6, and 12 months with clinical, duplex, and radiographic assessments. Failure was defined as >50% restenosis of the target lesion on duplex ultrasound imaging or stent fracture on X rays.. A total of 78 consecutive patients (46 males, 32 females) with 82 legs, mean age of 78.5 years (range, 57-97 years) were included. Symptoms of claudication, rest pain, and tissue loss were 48 (59%), 8 (10.1%), and 30 (37%), respectively. Ninety-six Supera stents were inserted in total. In 44 (53.7%) of the legs, stents were extended to the popliteal segments. The mean stented length was 12.6 cm (range, 4.0-38.0 cm). The primary patency rates at 6 and 12 months were 83.5% and 78.6%, respectively. The ankle brachial index increased from 0.58 ± 0.16 preoperative to 0.87 ± 0.14 postoperative. There were no stent fractures. Patency rate was not affected by severity of symptoms, stent lengths, femoro/popliteal stents (log-rank test, P = .50, .13, .52). All the patients reported symptomatic improvement. There was no procedural- or device-related morbidity or mortality, no major amputation after revascularization, and 10 patients died of unrelated cardiopulmonary/renal causes on follow-up.. Our early experience shows that the Supera stents are effective in our cohort of elderly patients, with acceptable patency rates. There were no stent fractures so far even with stenting of the popliteal segments.

Topics: Aged; Aged, 80 and over; Alloys; Angioplasty, Balloon; Ankle Brachial Index; Female; Femoral Artery; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Multivariate Analysis; Peripheral Arterial Disease; Popliteal Artery; Proportional Hazards Models; Prospective Studies; Prosthesis Design; Radiography; Risk Factors; Severity of Illness Index; Stents; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Duplex; Vascular Patency

To compare the patency rates and clinical outcomes of balloon angioplasty vs. nitinol stent placement for patients with short (≤150 mm) as compared to long (>150 mm) femoropopliteal (FP) occlusive lesions.. Between 2006 and 2011, 254 patients (134 men; mean age 68 years) underwent FP angioplasty. The majority of patients (64%) were treated for critical limb ischemia. One hundred thirty-nine (55%) patients had short FP lesions ≤150 mm, while 115 patients had long FP lesions >150 mm. The mean lesion length was 78±43 mm in the short FP lesion group and 254±58 mm in the long FP lesion group. Duplex ultrasound follow-up with a peak systolic velocity ratio ≥2.0 was used to define restenosis.. The overall procedure success rate was 98%. One hundred forty-eight (58%) patients underwent stent placement. The mean number of stents deployed for treatment of short FP lesions was 1.0±0.4 vs. 2.0±0.7 for long FP lesions (p<0.001). The primary patency rate of short FP lesions treated with balloon angioplasty vs. stenting was 66% vs. 63% at 1 year (p=0.7). For long FP lesions, the 1-year primary patency rates of balloon angioplasty vs. stenting were 34% vs. 49% (p=0.006). Balloon angioplasty of long FP lesions was also associated with significantly lower assisted primary and secondary patency compared to stenting (p<0.05 for all comparisons). Sustained clinical improvement was >90% at 30 days but declined to 62% to 75% at 1 year.. Balloon angioplasty and stent placement result in similar patency rates and clinical outcomes for shorter to medium-length FP lesions. In comparison, stent placement in long FP lesions is associated with superior outcomes to balloon angioplasty, even when multiple stents are required. Procedure success and clinical improvement can be achieved in the majority of patients, but rates of restenosis remain high.

Topics: Aged; Alloys; Angioplasty, Balloon; Blood Flow Velocity; Female; Femoral Artery; Humans; Male; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Prosthesis Design; Recurrence; Regional Blood Flow; Registries; Stents; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Duplex; Vascular Patency

The indication for use of drug-eluting stents (DES) in lower limb arteries is still undefined. We report our series of patients treated with Zilver PTS DES, in treating in-stent restenosis (ISR) and Trans-Atlantic Inter-Society Consensus Document on Management of Peripheral Arterial Disease (TASC) C/D femoropopliteal lesions.. The Zilver PTX DES is a self-expanding nitinol stent with a polymer-free Paclitaxel coating. Patients with symptomatic de novo TASC C/D lesions or IRS lesions of femoropopliteal segment were eligible for enrollment. We evaluated patients at one month, six months and one year after treatment. We used clinical evaluation criteria and US Doppler for primary and secondary patency-free rates.. From November 2010 to November 2012, we treated 69 patients with DES Zilver PTX. Indication to treat was given in 36 lesions (52%) by an ISR and in 33 cases (48%) by a TASC C/D lesion. Lesions were staged in the superficial femoral artery (SFA) level in 59 patients (85.6%), in the popliteal artery in 6 patients (8.7%), in a femoropopliteal bypass in 4 patients (5.7%). The mean follow-up was 5.3 months (range 1-24). At 12 months the overall primary patency was 85.5%, secondary patency 89.8% and limb salvage 100%.. Zilver PTX DES seems to be effective in treating TASC C/D lesions and ISR in femoropopliteal lesions at short term. Therefore DES should be recommended when treating those complex lesions.

Topics: Aged; Aged, 80 and over; Alloys; Cardiovascular Agents; Constriction, Pathologic; Disease-Free Survival; Drug-Eluting Stents; Endovascular Procedures; Female; Humans; Kaplan-Meier Estimate; Limb Salvage; Male; Middle Aged; Paclitaxel; Peripheral Arterial Disease; Prosthesis Design; Recurrence; Time Factors; Treatment Outcome; Ultrasonography, Doppler; Vascular Patency

Fatigue resistance of Nitinol stents implanted into femoro-popliteal arteries is a critical issue for the particular biomechanical environment of this district. Hip and knee joint movements due to the cyclic daily activity expose the superficial femoral artery (SFA), and therefore the implanted stents, to quite large and cyclic deformations influencing stent fatigue resistance. Objective of this work is to provide a tool based on finite element analysis able to evaluate the biomechanical effect of SFA on stent fatigue resistance. Computer simulations of the treatment of stenotic vessel by angioplasty and stenting and of the subsequent in vivo loading conditions (axial compression and bending) were carried out. Three different stenotic vessel models were defined, by keeping a constant stenosis rate and changing the plaque sharpness and number of stenoses. The fatigue behaviour was analysed comparing the amplitude and mean value distribution of the first principal strain in the whole stent for the different simulated conditions. Results showed that the maximum mean strain is similar in all the models, while the alternating strain is related to both plaque shape and loading conditions. In conclusion, this study confirms the requisite of replicating in vivo loading conditions. It also reveals the importance of taking into account the thickness variation of the vessel in the stenotic zone in the assessment of the stent fatigue resistance.

Topics: Alloys; Arterial Occlusive Diseases; Blood Flow Velocity; Blood Pressure; Blood Vessel Prosthesis; Compressive Strength; Computer Simulation; Computer-Aided Design; Equipment Failure Analysis; Humans; Materials Testing; Models, Cardiovascular; Peripheral Arterial Disease; Prosthesis Design; Prosthesis Failure; Shear Strength; Stents; Stress, Mechanical

To investigate the corrosion resistance properties of 5 commercially available nitinol stents used to treat peripheral artery disease and compare their surface quality, elemental composition, and geometrical design.. Samples of 5 different designs of nitinol peripheral stents [LifeStent (n=4), Philon (n=6), Epic (n=6), S.M.A.R.T. Control (n=7), and Complete SE (n=7)] were examined using stereomicroscopy, environmental scanning electron microscopy, and x-ray photoelectron spectroscopy. Corrosion resistance testing was performed in accordance with ASTM International Standard F2129-08.. Thirteen (43%) of 30 stents corroded during this experiment. Stent fracture was observed in 12 (92%) of these corroded stents. Mean breakdown potentials ranged from 517 to 835 mV (vs. Ag/AgCl) for the Philon, Complete SE, S.M.A.R.T. Control, Epic, and LifeStent models from lowest to highest. A statistically significant difference in breakdown potential was observed between the LifeStent vs. Philon stents (835 vs. 517 mV, p=0.01) and Epic vs. Philon stents (833 vs. 517 mV, p=0.03). Stents with lower breakdown potential and relative breakdown potentials were associated with a higher fracture frequency (Spearman correlation coefficient -0.44, p=0.015 and -0.869, p<0.01, respectively).. In this in vitro study, corrosion led independently to stent fracture. There is a significant association between lower mean breakdown/relative breakdown potentials and stent fracture.

Topics: Alloys; Corrosion; Endovascular Procedures; Humans; Materials Testing; Microscopy, Electron, Scanning; Peripheral Arterial Disease; Photoelectron Spectroscopy; Prosthesis Design; Prosthesis Failure; Stents; Surface Properties

Topics: Alloys; Endovascular Procedures; Humans; Peripheral Arterial Disease; Prosthesis Design; Prosthesis Failure; Stents

To report experience with the novel interwoven-wire self-expanding nitinol SUPERA stent (IDEV Technologies, Inc/Abbott Laboratories, Inc, Webster, Texas) for the treatment of severely diseased superficial femoral and popliteal arteries.. Consecutive patients with severely diseased superficial femoral and popliteal arteries who received SUPERA stents (n = 80 patients [98 limbs]; mean age, 70.8 y; 80% male) were retrospectively identified. Patients were followed for an average of 14.3 months after intervention.. Total occlusions were present in 39% of the lesions, 21% had tissue loss, and 61% demonstrated calcification on fluoroscopy. Patients were prescribed dual antiplatelet therapy (aspirin and clopidogrel) for at least 30 days unless contraindicated, followed by aspirin alone indefinitely. The mean (± SD) lesion length was 143 mm (± 98). Based on need for clinical intervention, primary patency was 96.9% at 6 months and 85.8% at 12 months (Kaplan-Meier estimates). Assisted primary patency and secondary patency rates at 12 months were 96.8% and 100%, respectively. Ankle-brachial index increased from 0.60 at baseline to 0.83 at last follow-up (P < .001). No stent fractures were found by fluoroscopy inspection in 19 limbs (16 patients) that required reintervention.. Based on experience with multiple operators at a single clinical center, the interwoven nitinol stent design provides a viable option for high-grade obstructive disease in the femoropopliteal artery.

Topics: Aged; Aged, 80 and over; Alloys; Ankle Brachial Index; Aspirin; Clopidogrel; Constriction, Pathologic; Drug Therapy, Combination; Endovascular Procedures; Female; Femoral Artery; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Peripheral Arterial Disease; Platelet Aggregation Inhibitors; Popliteal Artery; Predictive Value of Tests; Prosthesis Design; Radiography; Retrospective Studies; Severity of Illness Index; Stents; Ticlopidine; Time Factors; Treatment Outcome; Vascular Patency

To evaluate the 1-year patency of the 4-F Pulsar-18 self-expanding nitinol stent for treatment of femoropopliteal occlusive disease in a national, prospective, multicenter, all-comers registry.. Between January and June 2012, the German PEACE I all-comers prospective registry enrolled 148 patients with symptomatic femoropopliteal lesions (Rutherford category 2-5) undergoing recanalization and implantation of the Pulsar-18 SE nitinol stent at 6 clinical centers. Thirty patients did not have the 12-month follow-up visit (18 declined reevaluation, 5 withdrew consent, and 7 died), leaving 118 patients (64 men; mean 71.9±9.6 age years) for the 1-year evaluation. The average lesion length was 111.5±71.4 mm, and 38 of the 118 lesions were classified as TASC II D. More than half the lesions (67, 56.7%) were chronic total occlusions (CTO). The popliteal segment was involved in 22 (18.7%) lesions. The mean stented length was 122.7±64.5 mm. Routine follow-up included duplex ultrasound at 6 and 12 months. Outcome measures were primary patency and no clinically driven target lesion revascularization (TLR) within 12 months.. The overall primary patency rates after 6 and 12 months were 87.4% and 79.5%, respectively; in the popliteal segments, the rate was 71.4% after 12 months. The overall freedom from TLR was 93.2% after 6 months and 81% after 12 months. Ankle-brachial index, pain-free walking distance, and Rutherford category all improved significantly (p<0.0001) after 6 and 12 months. The primary patency rates in patients with diabetes (p=1.0) and those with renal insufficiency (p=0.8) were not significantly lower compared to the overall rate. There was no significant difference (p=0.67) in restenosis rate for recanalization of CTOs compared to non-CTO lesions.. In this all-comers registry, the use of the Pulsar-18 self-expanding nitinol stent in femoropopliteal lesions averaging 111.5 mm long showed promising primary patency and freedom from TLR after 6 and 12 months. Diabetes had no negative impact on patency. Primary patency in the popliteal segments was acceptable at 12 months.

Topics: Aged; Aged, 80 and over; Alloys; Angioplasty; Constriction, Pathologic; Disease-Free Survival; Female; Femoral Artery; Germany; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Prospective Studies; Prosthesis Design; Recurrence; Registries; Stents; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Duplex; Vascular Patency

Topics: Aged; Alloys; Angiography, Digital Subtraction; Angioplasty, Balloon; Aorta, Abdominal; Constriction, Pathologic; Device Removal; Foreign-Body Migration; Humans; Iliac Artery; Male; Middle Aged; Peripheral Arterial Disease; Prosthesis Design; Stents; Treatment Outcome; Vascular System Injuries

Topics: Alloys; Angioplasty; Device Removal; Female; Femoral Artery; Humans; Hypersensitivity; Intermittent Claudication; Middle Aged; Peripheral Arterial Disease; Remission Induction; Stents; Treatment Outcome

To investigate nitinol stent treatment of superficial femoral artery (SFA) lesions and the impact of different risk factors on the need for clinically driven target lesion revascularization (TLR) in a large, real-world population of claudicants.. Patients presenting with symptomatic SFA stenosis >70% were consecutively enrolled in the 13-center MARIS prospective registry (ClinicalTrials.gov identifier NCT01067885). There was no restriction on lesion length, thus leading to the inclusion of a real-world as well as high-risk patient cohort. The 998 participating patients (657 men; mean age 67.4±9.2 years) had 1050 lesions treated with the same nitinol stent type. The mean lesion length was 9.5±9.6 cm (range 0.5-44; median 8.0); more than a third of the lesions (450, 42.9%) were total occlusions. The primary endpoint was the need for clinically driven target lesion revascularization (TLR) at 12 months.. Acute technical success was achieved in 1042 (99.2%) lesions. Restenosis occurred in 187 (23.7%) and reocclusion in 79 (10.0%) lesions at 12 months. The primary endpoint of TLR at 12 months was reached by 136 (17.2%) patients. The periprocedural complication rate was 5.4%. Independent predictors of TLR were female gender [odds ratio (OR) 0.5, 95% confidence interval (CI) 0.3 to 0.7, p<0.001] and lesion length >20 cm vs. 10 cm (OR 2.7, 95% CI 1.1 to 6.6, p=0.029) and 10-20 cm vs. 10 cm (OR 1.9, 95% CI 1.0 to 4.1, p=0.047).. Stent implantation in the SFA is safe and associated with favorable acute and midterm results in a real-world setting. Lesion length and female gender were identified as independent risk factors for TLR.

Topics: Aged; Alloys; Angioplasty, Balloon; Constriction, Pathologic; Female; Femoral Artery; Germany; Humans; Intermittent Claudication; Ischemia; Kaplan-Meier Estimate; Logistic Models; Male; Middle Aged; Multivariate Analysis; Odds Ratio; Peripheral Arterial Disease; Prospective Studies; Prosthesis Design; Recurrence; Registries; Risk Factors; Sex Factors; Stents; Time Factors; Treatment Outcome

To investigate whether use of intravascular ultrasound (IVUS) improves primary patency following nitinol stenting for TASC II (TransAtlantic Inter-Society Consensus) A-C femoropopliteal lesions.. Using a retrospective multicenter database of 1198 limbs from 965 patients (695 men; mean age 72±9 years) with TASC II A-C lesions (28% critical limb ischemia) treated by provisional stenting from April 2004 to December 2011, primary patency rate was compared between 234 propensity score-matched pairs with vs. without IVUS use.. IVUS was used in 22% (n=268) of the overall population. It was more likely to be used in cases with generally more complicated femoropopliteal lesions (e.g., more severe TASC II class, longer lesion length, and narrower reference diameter). Analysis of the 234 propensity score-matched pairs (mean follow-up 1.9±1.5 years; 142 events) revealed higher 5-year primary patency with than without IVUS use (65%±6% vs. 35%±6%, p<0.001). IVUS resulted in significantly better assisted primary patency (p<0.001), secondary patency (p=0.004), freedom from any reintervention (p<0.001), freedom from any adverse limb event (p<0.001), and event-free survival (p<0.001).. IVUS use in femoropopliteal stenting for TASC II A-C lesions appears to be associated with higher primary patency rate.

Topics: Aged; Aged, 80 and over; Alloys; Constriction, Pathologic; Databases, Factual; Disease-Free Survival; Endovascular Procedures; Female; Femoral Artery; Humans; Japan; Kaplan-Meier Estimate; Male; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Propensity Score; Proportional Hazards Models; Prosthesis Design; Retrospective Studies; Risk Factors; Severity of Illness Index; Stents; Time Factors; Treatment Outcome; Ultrasonography, Interventional; Vascular Patency

Topics: Alloys; Blood Vessel Prosthesis Implantation; Constriction, Pathologic; Counterpulsation; Endovascular Procedures; Female; Femoral Artery; Humans; Intermittent Claudication; Middle Aged; Peripheral Arterial Disease; Prosthesis Design; Prosthesis Failure; Recurrence; Risk Factors; Stents; Tomography, X-Ray Computed; Treatment Outcome

The clinical impact of stent fractures is still controversial. This study analyzed the incidence and the clinical impact of stent fractures after stenting of long femoropopliteal lesions.. From November 2008 to October 2009, 58 patients (62 limbs) were treated in a single center with a primary nitinol self-expanding stent for Trans-Atlantic Inter-Consensus (TASC) C and D de novo femoropopliteal lesions. Patients were prospectively followed by medical and duplex scan examinations. Stent fractures were assessed by biplane X-rays at 12 months. Logistic regression analysis was performed.. At 1 year a complete follow-up was obtained in 42 limbs/90 stents. The median length of the stented segment was 240 ± 180 cm with a mean of 2.1 (1-4) stents per patient. Sixteen stents (17.8%) were fractured: one type I (asymptomatic); seven type II (2 restenosis); five type III (asymptomatic), and three type IV stent fractures (1 restenosis). Stent diameter (p = .04) and stent implantation in the distal part of the superficial femoral artery (p = .05) were positively associated with stent fractures. Stent fracture had no influence on restenosis.. This study suggests that the high stent fracture rate associated with endovascular treatment of long femoropopliteal lesions should be balanced with its low clinical impact.

Topics: Aged; Aged, 80 and over; Alloys; Angioplasty, Balloon; Chi-Square Distribution; Constriction, Pathologic; Female; Femoral Artery; Humans; Kaplan-Meier Estimate; Logistic Models; Male; Middle Aged; Multivariate Analysis; Odds Ratio; Peripheral Arterial Disease; Popliteal Artery; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Prosthesis Failure; Radiography; Recurrence; Risk Factors; Stents; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Duplex; Vascular Patency

Advances in stent technology have widened the field of indications for stent treatment of femoro-popliteal artery lesions, however the use of stents in bending arterial segments is restricted because some first- and second-generation nitinol stent designs did not respond well to the mechanical forces of femoro-popliteal segments in motion which pose a substantial risk of stent fracture inducing in-stent-stenosis. New generation nitinol stents are supposed to overcome these limitations but long-term results are rare.. In forty-five patients (mean age 68 y, range 50 - 85) with peripheral arterial disease (TASC II A-C, Rutherford category 2 - 5) forty-six lesions of the superficial femoral artery (37) or popliteal artery (9) were treated [25 high-grade stenoses, mean length 53 mm (range 30 - 145 mm); 21 chronic total occlusions, mean length 74 mm (range 30 - 180 mm)]. 74 % of lesions were located in the mobile bending arterial segments in the distal femoral or the popliteal segment. Clinical reevaluation performed at discharge, at 6, 12, 24, and 36 months included at least the measurement of ankle-brachial index (ABI) and duplex sonography.. Procedural success rate was 100 %. At 6, 12, 24, and 36 months, cumulative primary patency rate was 93.5 %, 84.8 %, 80.5 %, and 74.3 % (SE<10); freedom from target lesion revascularization rate was 95.7 %, 89.2 %, 84.9 %, and 79.3 % (SE<10); Rutherford category and ABI improved in all patients and clinical success was maintained in more than 85 % of patients.. Sustained technical and clinical success and good clinical long-term results were achieved with Misago™ nitinol stent implantation in femoro-popliteal lesions with moderate risk for in-stent-stenosis, and in the distal femoral and popliteal mobile segment.. Hintergrund: Der Einsatz von Nitinolstents im femoro-poplitealen Bewegungssegment ist beschränkt, da Nitinolstents der ersten und zweiten Generation aufgrund der hohen mechanischen Kräfte im femoropoplitealen Bewegungssegment ein beträchtliches Risiko für Restenose-induzierende Stentfrakturen aufwiesen. Nitinolstents der neuesten Generation sollen diesen Mangel minimieren, aber Langzeitbeobachtungen sind noch selten. Patienten und Methoden: Bei 45 Patienten (durchschnittliches Alter 68 Jahre, von 50 bis 85) mit peripherer arterieller Verschlusserkrankung (TASC II A-C, Rutherford-Kategorie 2 - 5) wurden 46 Läsionen der Arteria femoralis superficialis (n = 37) oder Arteria poplitea (n = 9) behandelt: 25 hochgradige Stenosen (durchschnittliche Länge 53 mm, 30 - 145 mm), und 21 chronische Totalverschlüsse (durchschnittliche Länge 74 mm, 30 - 180 mm). 74 % aller Läsionen befanden sich im distalen femoropoplitealen Bewegungssegment. Nachuntersuchungen wurden vor stationärer Entlassung sowie nach 6, 12, 24 und 36 Monaten durchgeführt und beinhalteten zumindest die Bestimmung des Arm-Knöchel-Dopplerdruckindexes (ABI) sowie Duplexsonographie. Ergebnisse: Die technische Erfolgsrate war 100 %. Nach 6, 12, 24, und 36 Monaten betrug die primäre kumulative Offenheitsrate 93.5 %, 84.8 %, 80.5 %, und 74.3 % (SE<10); 95.7 %, 89.2 %, 84.9 %, und 79.3 % (SE<10) der Patienten waren zu diesen Zeitpunkten frei von Reinterventionen der Zielläsion; eine anhaltende Verbesserung des klinischen Stadiums nach Rutherford und des ABI wurde bei mehr als 85% der Patienten erreicht. Schlussfolgerungen: Anhaltender technischer und klinischer Erfolg mit guten Langzeitergebnissen konnte erzielt werden mit der femoropoplitealen Implantation von Misago™ Nitinolstents in Läsionen der Femoropoplitealarterien, die ein mittleres Risiko für Restenosen aufweisen, Läsionen des distalen femoralen und poplitealen Bewegungssegmentes eingeschlossen.

Topics: Aged; Aged, 80 and over; Alloys; Angioplasty, Balloon; Ankle Brachial Index; Female; Femoral Artery; Germany; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Prospective Studies; Prosthesis Design; Stents; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Duplex; Vascular Patency

Aim of the study was to assess the long-term clinical results of primary stent placement in patients with femoro-popliteal lesions and intermittent claudication (IC) or critical limb ischemia (CLI).. Prospectively collected data of 517 patients (543 limbs) treated for IC (N.=422; 77.5%) and CLI (N.=121; 22.5%), between September 2006 and December 2010 were evaluated. Survival, limb salvage and patency rates were analyzed and multivariate analysis was performed to evaluate possible risk factors for the development of restenosis.. Mean patients' age was 70.6 years (SD ±10); 64.8% of the patients (N.=335) were male. Angiography revealed TASC A or B lesions in 64.5% (N.=350), TASC C or D lesions in 35.5% (N.=193) of the patients. Two hundred thirty-two patients had evidence of occluded femoropopliteal artery (42.7%) and the remaining patients had evidence of high grade (>70%) stenosis. In total, 827 bare metal nitinol stents (1.53±0.9 per limb) were used. No early (<30-day) procedure-related death was recorded. After a mean follow-up period of 60 months (SD ±13.5), 69 patients died (13.4%). Eight (1.5%) patients underwent major amputation. The amputation rate was significantly higher in the CLI group compared to the IC group (P=0.03). Primary patency rates were 86.2%, 79.1%, 75.1% and 62.2% after 1, 2, 3 and 5 years, respectively. No difference in terms of patency rates was found between the results of the treatment of TASC A/B versus TASC C/D lesions and the patient groups with IC versus CLI.. The endovascular-first line treatment with use of nitinol stents for patients with femoropopliteal artery lesions is associated with acceptable long-term patency rates, even in patients with long lesions.

Topics: Aged; Aged, 80 and over; Alloys; Amputation, Surgical; Chi-Square Distribution; Constriction, Pathologic; Critical Illness; Endovascular Procedures; Female; Femoral Artery; Germany; Humans; Intermittent Claudication; Ischemia; Kaplan-Meier Estimate; Limb Salvage; Logistic Models; Lower Extremity; Male; Middle Aged; Multivariate Analysis; Odds Ratio; Peripheral Arterial Disease; Popliteal Artery; Proportional Hazards Models; Prospective Studies; Prosthesis Design; Risk Factors; Stents; Time Factors; Treatment Outcome; Vascular Patency

Single center observational study analyzing the primary patency rate and freedom from target lesions revascularization rate of the Pulsar-18 nitinol stent after recanalization of long superficial femoral artery (SFA) occlusions (TASC D) in 22 patients with critical limb ischemia (CLI).. Between 1/2011 and 7/2011, 22 consecutive patients (9 male, 13 female) with chronic total occlusions (CTO) of the femoro-popliteal arteries presenting with CLI (17 patients with Rutherford 4 score, and 5 patients with Rutherford 5 score) were enrolled and successfully recanalized using the Pulsar-18 self-expanding (SE) nitinol stent (BIOTRONIK AG, Buelach, Switzerland). Primary patency at 12 months was defined as no binary restenosis (>50%) on Duplex ultrasound (PSVR<2.5) and respectively no target lesion revascularization performed within 12 months. The average lesion length of the treated femoro-popliteal segment was 315 mm. Performing spot stenting average stent length in all patients was 245 mm (minimal 215 mm, maximal 315 mm).. Technical success, with establishing an antegrade straight line flow to the foot through a reopened SFA, was achieved in all 22 patients. Subintimal and intraluminal recanalization techniques were used. Two patients with Rutherford 5 score had a minor amputation shortly after the recanalization procedure. All other patients had a complete wound healing of their lesions during a 6 month follow-up. After 12 month follow-up the primary patency rate of the Pulsar-18 SE nitinol stent was 77% with a per protocol restenosis in 5 of 22 patients. Seventeen patients showed a walking capacity on treadmill test >300 meters (Rutherford II). Two patients with a documented restenosis were Rutherford, these patients were treated conservatively. Three patients with restenosis and a Rutherford III score were scheduled for an endovascular target lesion revascularization leading to a freedom from target lesion revascularization rate of 86%.. Endovascular intervention of long SFA occlusions using subintimal or intraluminal recanalization technique with implantation of the Pulsar-18 SE nitinol stent in CLI patients is safe and clinically effective with a primary patency rate after 12 months of 77% and a freedom from target lesion revascularization rate of 86%.

Topics: Aged; Alloys; Amputation, Surgical; Angioplasty, Balloon; Chronic Disease; Constriction, Pathologic; Critical Illness; Exercise Test; Exercise Tolerance; Female; Femoral Artery; Germany; Humans; Ischemia; Kaplan-Meier Estimate; Limb Salvage; Lower Extremity; Male; Peripheral Arterial Disease; Predictive Value of Tests; Prosthesis Design; Recovery of Function; Registries; Stents; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Duplex; Vascular Patency; Wound Healing

The aim of this study was to collect procedural and clinical data assessing safety and performance of the GORE® TIGRIS® Vascular Stent, a novel dual component stent, made of a nitinol wire frame combined with a fluoropolymer-interconnecting structure.. This retrospective analysis included 32 consecutive patients (20 men, mean age 72.8 years) with 40 atherosclerotic femoropopliteal lesions (occlusions in 5%) who underwent angioplasty and implantation of a GORE® TIGRIS® Vascular Stent. The patients were scheduled for follow-up at 3, 6 and 12 months after stent implantation for Duplex ultrasound and assessment of Rutherford Becker class (RBC) and Ankle-Brachial Index (ABI) RESULTS: The mean implanted stent length was 62.3 mm (range 30-100 mm). Procedural success (residual stenosis <30%) was achieved in 100% of the lesions. At 6 months 2 restenosis in 2 patients were observed, resulting in a cumulative primary patency rate (±standard error) of 91.7±8.0%. Between baseline and 6 months the ABI increased from 0.65±0.18 to 0.96±0.12 (P<0.0001) and the median of RBC increased from 3 to 1.5 (P<0.0005). No stent thrombosis was found.. In this retrospective collection of patients all lesions could be successfully treated with this novel hybrid TIGRIS stent. These preliminary results show promising primary patency rates at 6 months. In addition, significant improvements were observed in symptom classification and hemodynamics.

Topics: Aged; Aged, 80 and over; Alloys; Angiography, Digital Subtraction; Angioplasty, Balloon; Ankle Brachial Index; Constriction, Pathologic; Female; Femoral Artery; Humans; Kaplan-Meier Estimate; Lower Extremity; Male; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Predictive Value of Tests; Prosthesis Design; Retrospective Studies; Stents; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Duplex; Vascular Patency

To evaluate the efficacy and safety of the EPIC self-expanding nitinol stent in patients with femoropopliteal occlusive disease.. The prospective, multicenter, nonrandomized SUMMIT study (ClinicalTrials.gov identifier NCT01336101) enrolled 100 patients (76 men; mean age 67.6 years) with symptomatic de novo femoropopliteal disease undergoing angioplasty and subsequent implantation of EPIC stents from April 2011 to October 2011. The mean lesion length was 69.5±40.5 mm; 29 of the lesions were total occlusions. Clinical examination and duplex sonography were prospectively performed after 6 and 12 months. The primary endpoint was in-stent restenosis as assessed by duplex ultrasound (peak systolic velocity ratio ≥2.5). Further outcome measures were patency rates, improvement in the Rutherford category and ankle-brachial index (ABI), as well as stent integrity based on plain radiography.. A residual stenosis <30% was achieved in all procedures. The primary patency rates were 96.8% after 6 months and 85.1% at 1 year. The secondary patency rates were 97.9% and 91.2% at the same intervals. The 1-year binary >50% restenosis rate was 15.7%. Freedom from target lesion revascularization at 1 year was 92.3%. Between baseline and the 12-month follow-up, the mean ABI increased from 0.73 to 0.96, and the mean Rutherford category decreased from 2.9 to 1.0 (p<0.001 for both comparisons). Plain radiographs from 86 patients at the 12-month examination confirmed the absence of stent fractures.. The outcome of the SUMMIT registry demonstrates that the EPIC self-expanding nitinol vascular stent is a safe and effective device for treating peripheral artery disease in the femoropopliteal segment.

Topics: Aged; Alloys; Angioplasty, Balloon; Ankle Brachial Index; Constriction, Pathologic; Female; Femoral Artery; Germany; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Prospective Studies; Prosthesis Design; Radiography; Recurrence; Registries; Stents; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Duplex; Vascular Patency

Topics: Alloys; Angioplasty, Balloon; Female; Femoral Artery; Humans; Male; Peripheral Arterial Disease; Popliteal Artery; Stents

To elucidate the optimal cutoff and accuracy of duplex ultrasonography (DUS) parameters for in-stent restenosis (ISR) after nitinol stenting in the superficial femoral artery (SFA).. Few data are available regarding the performance of DUS for binary ISR based on quantitative vessel analysis (QVA) in the era of SFA nitinol stenting.. This retrospective study included 74 in-stent stenoses of SFA who underwent DUS before follow-up angiography. DUS parameters, such as peak systolic velocity (PSV) and the peak systolic velocity ratio (PSVR), were compared with percent diameter stenosis (%DS) from a QVA basis.. There was a statistically significant correlation (P < 0.001) between "%DS and PSV" and "%DS and PSVR," and the correlation with %DS proved to be stronger in PSVR (R = 0.720) than in PSV (R = 0.672). The best performing parameter for ISR (50% or greater stenosis) was revealed PSVR, as the areas under the receiver operator characteristics curves using PSVR and PSV were 0.908 and 0.832, respectively. A PSVR cut off value of 2.85 yielded the best predictive value with sensitivity of 88%, specificity of 84%, and accuracy of 86%. The positive predictive value was 85% and the negative predictive value was 88%.. A PSVR of 2.85 is the optimal threshold for ISR after nitinol stenting in the SFA. Further large prospective studies are required for the validation and establishment of uniform criteria for DUS parameters.

Topics: Aged; Aged, 80 and over; Alloys; Angioplasty, Balloon; Area Under Curve; Blood Flow Velocity; Constriction, Pathologic; Female; Femoral Artery; Humans; Male; Middle Aged; Peripheral Arterial Disease; Predictive Value of Tests; Prosthesis Design; Radiography; Recurrence; Regional Blood Flow; Retrospective Studies; ROC Curve; Stents; Treatment Outcome; Ultrasonography, Doppler, Duplex; Vascular Patency

Placement of arterial endoprostheses across the inguinal ligament is generally thought to be contraindicated for fear of device kinking, fracture, or occlusion and possible obliteration of the deep femoral artery (DFA). We present a series of selected patients who underwent insertion of polytetrafluoroethylene-covered nitinol stents (Viabahn stent grafts. W. L. Gore and Associates Inc, Flagstaff, Ariz) crossing the middle common femoral artery (CFA) on an emergency basis or who were considered high risk for open surgery.. We treated 16 patients with 17 lesions adjacent to or within the CFA with stent grafts that originated in the common iliac (two) or external iliac (15) artery and terminated in the distal CFA (12), DFA (three), or superficial femoral (two) artery. Stent grafts were placed on an elective (10) or emergency (seven) basis for arterial occlusive disease (10), bleeding (six), and aneurysmal disease (one). Comorbidities favoring endovascular treatment were high medical risk (10) previous scarring (four), morbid obesity (two), and dense arterial calcification precluding open surgical repair (one).. The DFA was deliberately sacrificed in one of the 17 cases. No patient suffered major complications after the procedure. All grafts remained patent based on duplex ultrasound imaging during follow-up (mean, 12.3 months; range, 1-58 months). Two patients required an additional endovascular intervention to treat inflow or outflow stenoses during follow-up, yielding a 2-year primary patency rate of 93.8% and assisted primary patency rate of 100%.. These results suggest that selective placement of Viabahn stent grafts across the inguinal ligament to treat arterial occlusive disease or bleeding may prove to be safe, effective, and associated with acceptable patency rates. This strategy helps avoid complicated open arterial surgery in high-risk patients with associated multiple medical risk factors or hostile scarred groins.

Topics: Aged; Aged, 80 and over; Alloys; Angioplasty, Balloon; Blood Vessel Prosthesis Implantation; Coated Materials, Biocompatible; Comorbidity; Female; Femoral Artery; Humans; Iliac Artery; Kaplan-Meier Estimate; Ligaments; Male; Middle Aged; Peripheral Arterial Disease; Polytetrafluoroethylene; Prosthesis Design; Radiography; Retrospective Studies; Risk Factors; Stents; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Duplex; Vascular Patency

Topics: Alloys; Angioplasty, Balloon; Blood Vessel Prosthesis Implantation; Coated Materials, Biocompatible; Female; Femoral Artery; Humans; Ligaments; Male; Peripheral Arterial Disease; Polytetrafluoroethylene; Stents

We examined the efficacy and durability of a new interwoven self-expanding nitinol stent system in the treatment of complex popliteal artery lesions in unselected patients.. The optimal endovascular treatment strategy for atherosclerotic popliteal artery disease is not known.. We retrospectively analyzed the data gathered in 101 consecutive patients presenting with atherosclerotic, popliteal arterial disease, who underwent implantation of 125 stents. The patients were followed for 12 months by Doppler ultrasound examinations, stent roentgenograms, and estimation of Rutherford-Becker class (RBC) and ankle-brachial index (ABI).. The mean age of the patients was 73.1 years, and 52.5% were men. Total occlusions were present in 48 patients (47.5%). The mean stent length was 84.3 ± 45.1 mm (range 40 to 240 mm). A <30% residual stenosis was achieved in 98.0% of procedures. The 6- and 12-month primary patency rates were 94.6 ± 2.3% and 87.7 ± 3.7%, respectively, and the secondary patency rates 97.9 ± 1.5% and 96.5 ± 2.0%, respectively. Between baseline and 12 months of follow-up, mean ABI increased from 0.58 ± 0.15 to 0.97 ± 0.18, and mean RBC decreased from 3.1 ± 0.9 to 1.4 ± 0.8 (p < 0.001 for both comparisons). Radiographs performed on 51 patients, at a mean of 15.2 months, confirmed the absence of stent fractures in 100% of examinations.. Over a 12-month observation period, the patency rate and durability of SUPERA stents implanted for severe popliteal artery disease were high.

Topics: Aged; Aged, 80 and over; Alloys; Angioplasty; Ankle Brachial Index; Constriction, Pathologic; Female; Germany; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Predictive Value of Tests; Prosthesis Design; Radiography; Registries; Retrospective Studies; Severity of Illness Index; Stents; Time Factors; Treatment Outcome; Ultrasonography, Doppler; Vascular Patency

Restenosis after endovascular treatment for superficial femoral artery (SFA) disease remains a significant clinical issue. We assessed whether cilostazol reduce restenosis after SFA stenting with self-expandable nitinol stent.. The study was a multicenter, prospective maintained database, retrospective analysis. From April 2004 to December 2009, 861 consecutive patients (mean age 71 years, 71% male) who underwent successful stenting for de novo lesions were retrospectively identified. Of them, 492 received cilostazol (cilostazol(+)) and 369 did not receive cilostazol (cilostazol(-)) after procedure. Propensity-score analyses matched 281 cilostazol(+) with 281 cilostazol (-) group. Primary endpoint was binary restenosis rate. Secondary endpoints were reocclusion, all-cause mortality and limb salvage in patients with critical limb ischemia (CLI). Restenosis was defined as >2.4 of peak systolic velocity ratio by duplex.. Mean follow-up period was 25 months. According to analysis of matched pairs, binary restenosis rates were significantly lower (31.2% vs. 42.9% at 5-year, P = 0.02). In-stent re-occlusion rate tended to be lower in patients who received cilostazol (10.8% vs. 18.2% at 5-year, P = 0.09) compared with control. No significant difference of all-cause mortality (21.4% vs. 18.3% at 5-year, P = 0.84) and limb salvage rate in patients with CLI (86.2% vs. 78.5% at 5-year, P = 0.29) was found between both groups. After adjustment for prespecified risk factors, cilostazol was an independent negative predictor of restenosis. In subgroup analysis, male, age <75 years, claudicant patients, TASCII C/D, small vessels and poor runoff vessel was significantly lower in binary restenosis.. Cilostazol reduced restenosis after SFA stenting with self-expandable nitinol stent and it seems to be more effective in high-risk patients for restenosis.

Topics: Aged; Aged, 80 and over; Alloys; Angioplasty; Chi-Square Distribution; Cilostazol; Constriction, Pathologic; Female; Femoral Artery; Humans; Japan; Kaplan-Meier Estimate; Limb Salvage; Logistic Models; Male; Matched-Pair Analysis; Middle Aged; Multivariate Analysis; Peripheral Arterial Disease; Platelet Aggregation Inhibitors; Propensity Score; Proportional Hazards Models; Prosthesis Design; Retrospective Studies; Risk Assessment; Risk Factors; Secondary Prevention; Stents; Tetrazoles; Time Factors; Treatment Outcome

Initial TransAtlantic Inter-Society consensus (TASC) II classification has been shown to influence the patency of stented femoral and popliteal arteries. Although several studies have shown the effect of the number of runoff vessels on the durability of infrainguinal angioplasty without stenting, the influence of tibial vessel runoff on the patency of primarily stented femoral and popliteal arteries has not been as well defined. The purpose of this study was to determine whether the number of patent tibial vessels affects primary patency after primary stenting of the femoral and popliteal arteries.. The records of all patients undergoing angioplasty and primary nitinol stenting of the femoral and popliteal arteries, by or under the supervision of one vascular surgeon, were reviewed. Results were analyzed by both the number of patent tibial vessels documented on periprocedural angiography and by using a modified Society for Vascular Surgery runoff score. TASC II classification was also recorded. Kaplan-Meier survival curves were plotted and differences between groups tested by log-rank method. Fisher exact and χ(2) tests were used to compare categoric factors.. During a 7-year period, 289 limbs in 236 patients underwent primary stenting of the femoral and popliteal arteries. Overall primary patency was 70.3% at 12 months, 52.4% at 24 months, and 39.1% at 36 months. Limbs classified as TASC A or B had significantly better patency rates than those classified as TASC C or D (P < .001). While the number of runoff vessels decreased with worsening of the TASC classification (P = .024), overall (P = .355), and within individual TASC classes (P ≥ .092 for each), there was no difference in the primary patency of stented segments with good runoff and those with compromised runoff. Limbs with poor runoff (one or no vessels) were no more likely to fail with occlusion than their counterparts with two or three patent tibial vessels (P = .383). The number of patent tibial vessels at the time of initial stenting did not impact ultimate limb salvage (P = .063).. The number of patent tibial vessels does not influence the primary patency of primarily stented femoral and popliteal arteries. TASC II classification appears to be significantly more predictive of initial failure after angioplasty and stenting of these vessels.

Topics: Aged; Aged, 80 and over; Alloys; Analysis of Variance; Cohort Studies; Female; Femoral Artery; Follow-Up Studies; Humans; In Vitro Techniques; Kaplan-Meier Estimate; Male; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Radiography; Retrospective Studies; Severity of Illness Index; Stents; Tibial Arteries; Treatment Outcome; Vascular Patency

Percutaneous transluminal angioplasty (PTA) with stent deployment of infrapopliteal arteries is an accepted but unproven therapy for patients with critical limb ischemia (CLI). We evaluated the safety and effectiveness of the Xpert™ self-expanding nitinol stent (Abbott Vascular, Redwood City, CA) in Rutherford Class 4-6 subjects with infrapopliteal lesions of 4-15 cm in length.. 120 patients (140 limbs, 212 implanted devices) underwent primary infrapopliteal nitinol stent deployment as part of this multicenter registry. The primary endpoint was 12-month amputation-free survival (AFS); secondary endpoints included limb salvage, target lesion revascularization (TLR), 6- month angiographic patency, and 6- and 12-month outcomes of wound healing and pain relief. Despite a 6-month binary stent restenosis rate of 68.5%, the 12-month AFS rate was 78.3%. Stratified according to baseline Rutherford classes 4, 5 and 6, the 12-month AFS rates were 100%, 77.3%, and 55.2%, respectively, and freedom from major amputation rates were 100%, 90.9%, and 70.1%, respectively. The 12-month freedom from major amputation rate and clinically driven TLR were 89.6% and 70.1%, respectively. The 6- and 12-month complete wound-healing rates were 49.0% and 54.4%, respectively. Rutherford class 4 patients had significant pain relief through 12-months (P<0.05).. Primary infrapopliteal nitinol stenting to treat CLI is safe and effective in improving 6-and 12-month clinical outcomes.

Topics: Aged; Aged, 80 and over; Alloys; Amputation, Surgical; Angioplasty, Balloon; Constriction, Pathologic; Critical Illness; Female; Humans; Ischemia; Kaplan-Meier Estimate; Limb Salvage; Lower Extremity; Male; Pain; Peripheral Arterial Disease; Popliteal Artery; Prospective Studies; Prosthesis Design; Recurrence; Registries; Stents; Time Factors; Treatment Outcome; United States; Vascular Patency; Wound Healing

Several studies showed durable long-term clinical benefit of endovascular therapy with stenting in aorto-iliac occlusive disease. Although in-stent restenosis is easily treated in routine practice, we experienced an uncommon case of failed reconstitution of in-stent total occlusion at the common iliac artery (CIA). The case was treated with nitinol stent implantation outside of the in-stent occlusion site, and good vessel patency was observed at 14 months after the procedure. Nitinol stent implantation outside of an in-stent occlusion in the CIA is a novel reconstitution strategy when the guide wire cannot pass the occlusion site within a previously implanted stent.

Topics: Aged; Alloys; Blood Vessel Prosthesis Implantation; Endovascular Procedures; Humans; Iliac Artery; Male; Peripheral Arterial Disease; Stents; Treatment Outcome; Vascular Patency

To evaluate the clinical efficacy of EverFlex stents (length, 6-20 cm) for the treatment of peripheral artery disease (PAD) in the superficial femoral artery (SFA).. Over a period of 18 months, 56 SFA lesions in 53 patients were treated with an EverFlex stent. The following parameters were documented before the intervention, immediately afterward, and 12 months later: clinical stage, ankle-brachial index, and peak systolic velocity ratio (PSVR). The primary study endpoint was the primary patency rate after 12 months (defined as a PSVR < 2.5).. In 18% of the 56 lesions, complete occlusions were present. Mean lesion length was 9.4 cm ± 5.3, and mean stent length was 12.6 cm ± 5.6. Of the 53 patients enrolled in the study, a 12-month follow-up was performed in 46. The primary patency rate after 12 months was 71.7%. In-stent restenosis or occlusion occurred in 13 patients. Compared with the total study group, the mean stent length in these 13 patients was greater (14.0 cm ± 7.3) and the incidence of de novo lesions was lower. In the patient group with stents less than 10 cm in length (n = 24), six patients (25%) required a repeat intervention, compared with seven patients (32%) in the group with stents longer than 12 cm.. Although the primary patency rate associated with the EverFlex stent is comparable to those in published data, the present results demonstrate a higher percentage of in-stent stenoses in patients in whom longer SFA stents were implanted.

Topics: Aged; Alloys; Ankle Brachial Index; Blood Flow Velocity; Constriction, Pathologic; Endovascular Procedures; Female; Femoral Artery; Humans; Male; Middle Aged; Peripheral Arterial Disease; Prosthesis Design; Recurrence; Regional Blood Flow; Retrospective Studies; Stents; Time Factors; Treatment Outcome; Vascular Patency

Although endovascular stent treatment is increasingly used in infrainguinal atherosclerotic occlusive disease, outcome with focus on gender differences has not been reported in detail.. One hundred and twelve consecutive patients (67 [60%]) women, undergoing endovascular nitinol stent treatment of atherosclerotic lesions in the femoropopliteal segment were analysed concerning improvement in ankle brachial index (ABI), reinterventions, complications, amputation and survival rates up to 12 months after intervention. Risk factors for amputation and death were analyzed with logistic regression.. At presentation, women showed critical limb ischemia (CLI) more often than men (87% vs. 58 %; P = 0.001). After 12 months ABI had improved (from 0.40 ± 0.26 at baseline to 0.86 ± 0.22 after 12 months, P < 0.001), but 16 patients (15%) had been amputated and 27 patients (24 %) had died. After adjustment for age, diabetes mellitus and smoking, female gender was an independent risk factor for amputation (OR 9.0; 95% CI 1.1-76.5; P = 0.045).. Stent treatment of lesions in the femoropopliteal segment had favourable effects on ABI and limb salvage. Treated women more often had CLI and ran a higher risk for amputation within 12 months than men. This might reflect failure of clinicians to adequately appreciate symptoms of atherosclerotic leg artery disease in women.

Topics: Aged; Aged, 80 and over; Alloys; Amputation, Surgical; Angioplasty; Ankle Brachial Index; Female; Femoral Artery; Follow-Up Studies; Humans; Kaplan-Meier Estimate; Limb Salvage; Logistic Models; Male; Middle Aged; Multivariate Analysis; Peripheral Arterial Disease; Popliteal Artery; Postoperative Complications; Reoperation; Risk Factors; Sex Factors; Stents; Survival Rate; Treatment Outcome

We describe a ViaBahn Open Revascularization TEChnique (VORTEC) application in peripheral femoro-popliteal polytetrafluoroethylene (PTFE) graft bypass in 13 patients.

Topics: Alloys; Anastomosis, Surgical; Blood Vessel Prosthesis; Blood Vessel Prosthesis Implantation; Coated Materials, Biocompatible; Endovascular Procedures; Femoral Artery; Hospital Costs; Humans; Israel; Peripheral Arterial Disease; Polytetrafluoroethylene; Popliteal Artery; Prosthesis Design; Severity of Illness Index; Stents; Tomography, X-Ray Computed; Treatment Outcome

To examine the efficacy and integrity of a novel interwoven self-expanding nitinol stent system for the treatment of complex femoropopliteal lesions in a "real world" medical practice.. This retrospective analysis included 107 consecutive patients (77 men; mean age 68.9 years) with atherosclerotic femoropopliteal lesions (occlusions in 31%) who underwent implantation of 137 SUPERA stents. The patients were followed for up to 24 months by Doppler ultrasound examinations, radiography of the stent, and assessments of Rutherford-Becker class and ankle-brachial index (ABI).. The mean implanted stent length was 111±50 mm (range 40-270). Procedure success (residual stenosis <30%) was achieved in 99% of procedures. The 6-, 12-, and 24-month cumulative primary patency rates (± standard error) were 93.1%±2.5%, 84.7%±3.6%, and 76.1%±4.5%, respectively, and the secondary patency rates were 99.0%±0.1%, 94.8%±0.2% and 91.9%±0.3%, respectively. Between baseline and 24 months, mean ABI increased from 0.68±0.14 to 0.87±0.10 and the mean Rutherford-Becker class decreased from 3.3±0.7 to 2.0±1.0 (p<0.0001 for both). Radiographs performed in 91 patients at a mean of 16.8±7.0 months found no stent fractures.. Over a 2-year surveillance period, excellent durability without stent fractures was documented after implantation of the SUPERA stent in complex femoropopliteal lesions. In addition, significant improvements were observed in symptom classification and hemodynamics.

Topics: Adult; Aged; Aged, 80 and over; Alloys; Female; Femoral Artery; Follow-Up Studies; Humans; Male; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Prosthesis Design; Retrospective Studies; Stents; Treatment Outcome

To investigate the long-term outcomes of nitinol stenting in femoropopliteal lesions and to determine the factors associated with restenosis.. Between December 2003 and December 2009, 861 patients (603 men; mean age 72 years) underwent nitinol stenting of the femoropopliteal segment in 1017 limbs. A quarter (26%) of the patients had critical limb ischemia. Mean lesion length was 152±93 mm. Stent patency was assessed by either duplex ultrasound or angiography and analyzed by Kaplan-Meier estimation. The determinants of restenosis were explored with Cox proportional hazard regression analyses; the results are presented as the hazard ratio (HR) and 95% confidence interval (CI). Risk stratification of primary patency was subsequently analyzed using a score based on the significant prognostic factors identified in the multivariate model.. Stent fracture occurred in 10% (104 limbs) of the lesions. At 1, 3, and 6 years, the primary patency rates were 77%, 67%, and 63%; secondary patency rates were 91%, 87%, and 87%; freedom from femoropopliteal bypass grafting was 99%, 97%, and 96%, respectively. Multivariate Cox regression analysis identified female gender (HR 1.899; 95% CI 1.318 to 2.737, p<0.001), ankle-brachial index <0.6 (HR 1.921; 95% CI 1.348 to 2.736, p<0.001), TASC II C/D lesion (HR 2.068; 95% CI 1.346 to 3.177, p = 0.0009), stent fracture (HR 1.937; 95% CI 1.203 to 3.118, p = 0.006), and the absence of cilostazol administration (HR 2.102; 95% CI 1.394 to 3.172, p<0.001) as strong independent factors associated with restenosis. After assigning a risk score based on the outcomes of the multivariate regression analysis (1 each for female gender, ABI <0.6, TASC II C/D, stent fracture, and absence of cilostazol therapy), primary patency was found to be lower in limb groups with a higher cumulative score (12-month primary patency: score 0: 93%, score 1: 80%, score 2: 73%, score 3; 47%, score 4: 0%, respectively; p<0.001).. Endovascular therapy using nitinol stents for FP lesions yielded acceptable outcomes up to 6 years. Risk stratification for patency can play an important role in estimating future occurrence of restenosis after nitinol stent implantation in FP lesions.

Topics: Alloys; Endovascular Procedures; Female; Femoral Artery; Follow-Up Studies; Graft Occlusion, Vascular; Humans; Male; Multivariate Analysis; Peripheral Arterial Disease; Popliteal Artery; Prosthesis Design; Retrospective Studies; Risk Factors; Stents; Treatment Outcome; Vascular Patency

The authors report the case of a patient with acute lower limb ischemia (category IIa) after occlusion of the popliteal artery due to fracture of a long indwelling stent. The patient refused surgical therapy for religious reasons, and an interventional revascularization was performed as acute rescue therapy. After reentry into the distal popliteal artery was achieved, the artery was dilated, and the fragmented stent was crushed, followed by implantation of two helical nitinol stents with high radial force and a third self-expandable nitinol stent. Sufficient primary technical success was achieved, and stent patency was present at midterm follow-up.

Topics: Acute Disease; Alloys; Angiography, Digital Subtraction; Angioplasty, Balloon; Arterial Occlusive Diseases; Constriction, Pathologic; Humans; Ischemia; Lower Extremity; Magnetic Resonance Angiography; Male; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Prosthesis Design; Prosthesis Failure; Stents; Treatment Outcome; Ultrasonography, Doppler, Color; Vascular Patency