nitinol and Intermittent-Claudication

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

Intermittent claudication (IC) is commonly caused by lesions in the superficial femoral artery (SFA), yet invasive treatment is still controversial and longer term patient-reported outcomes are lacking. This prospective randomized trial assessed the 24-month impact of primary stenting with nitinol self-expanding stents compared to best medical treatment (BMT) alone in patients with stable IC due to SFA disease on health-related quality of life (HRQoL).. One hundred patients with stable IC due to SFA disease treated with BMT were randomized to either stent (n = 48) or control (n = 52) group. HRQoL assessed by Short Form 36 Health Survey (SF-36) and EuroQoL 5-dimensions (EQ5D) 24 months after treatment were primary outcome measures. Walking Impairment Questionnaire, ankle-brachial index (ABI), and walking distance were secondary outcomes.. Significantly better SF-36 Physical Component Summary (P = 0.024) and physical domain scores such as Physical Function (P = 0.012), Bodily Pain (P = 0.002), General Health (P = 0.037), and EQ5D (P = 0.010) were reported in intergroup comparison between the stent and the control group. Both ABI (from 0.58 ± 0.11 to 0.85 ± 0.18; P < 0.001 in the stent group and from 0.63 ± 0.17 to 0.69 ± 0.18; P = 0.036 in the control group) and walking distance (from 170 ± 90 m to 616 ± 375 m; P < 0.001 in the stent group and from 209 ± 111 m to 331 ± 304 m; P = 0.006 in the control group) improved significantly in intragroup comparisons.. In patients with IC caused by lesions in the SFA, primary stenting compared to BMT alone was associated with significant improvements in HRQoL, ABI, and walking distance durable up to 24 months of follow-up. Clinical Trial Registration http://www.clinicaltrials.gov . Unique Identifier: NCT01230229.

Topics: Aged; Alloys; Female; Femoral Artery; Follow-Up Studies; Humans; Intermittent Claudication; Male; Prospective Studies; Quality of Life; Stents; Surveys and Questionnaires; Sweden; Time Factors; Treatment Outcome

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 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

To evaluate longer outcomes of primary nitinol stenting for the treatment of femoropopliteal lesions up to 15 cm long after these stents were found to have superior short-term patency vs. balloon angioplasty.. Two hundred and six patients (143 men; mean age 67 years) with intermittent claudication due to superficial femoral and proximal popliteal artery lesions were randomized (2:1) to treatment with nitinol stents or balloon angioplasty at 24 US and European centers and followed for 3 years. In that time, 15 patients died, 20 withdrew consent, and 10 were lost to follow-up, leaving 161 (78.2%) patients for 36-month assessment.. The 12-month freedom from target lesion revascularization (TLR) was 87.3% for the stent group vs. 45.2% for the angioplasty group (p<0.0001). At 3 years, there was no difference in survival (90.0% vs. 91.7%, p=0.71) or major adverse events (75.2% vs. 75.2%, p=0.98) between the stent and angioplasty groups. Duplex ultrasound was not mandated after the first year, so stent patency could not be ascertained beyond 1 year, but freedom from TLR at 3 years was significantly better in the stent group (75.5% vs. 41.8%, p<0.0001), as was clinical success (63.2% vs. 17.9%, p<0.0001). At 18 months, a 4.1% (12/291) stent fracture rate was documented.. In this multicenter trial, primary implantation of a nitinol stent for moderate-length lesions in the femoropopliteal segment of patients with claudication was associated with better long-term results vs. balloon angioplasty alone.

Topics: Aged; Alloys; Angioplasty, Balloon; Arterial Occlusive Diseases; Chi-Square Distribution; Constriction, Pathologic; Europe; Female; Femoral Artery; Humans; Intermittent Claudication; Kaplan-Meier Estimate; Male; Middle Aged; Popliteal Artery; Predictive Value of Tests; Prosthesis Design; Radiography; Risk Assessment; Risk Factors; Stents; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Duplex; United States; Vascular Patency

The purpose of this study is to compare post-dilation strategies of nitinol self-expanding stents implanted in the superficial femoral artery of diabetic patients with peripheral arterial disease.. Endovascular treatment of superficial femoral artery disease with nitinol self-expanding stents is associated with high rates of in-stent restenosis in patients with diabetes mellitus.. We conducted a prospective, multicenter, randomized, controlled clinical trial of diabetic patients to investigate whether post-dilation of superficial femoral artery nitinol self-expanding stents using a cryoplasty balloon reduces restenosis compared to a conventional balloon. Inclusion criteria included diabetes mellitus, symptomatic peripheral arterial disease, and superficial femoral artery lesions requiring implantation of stents>5 mm in diameter and >60 mm in length. Primary endpoint was binary restenosis at 12 months, defined as ≥2.5-fold increase in peak systolic velocity by duplex ultrasonography.. Seventy-four patients, with 90 stented superficial femoral artery lesions, were randomly assigned to post-dilation using cryoplasty (n=45 lesions) or conventional balloons (n=45 lesions). Mean lesion length was 148±98 mm, mean stented length was 190±116 mm, mean stent diameter was 6.1±0.4 mm, and 50% of the lesions were total occlusions. Post-dilation balloon diameters were 5.23±0.51 mm versus 5.51±0.72 mm in the cryoplasty and conventional balloon angioplasty groups, respectively (p=0.02). At 12 months, binary restenosis was significantly lower in the cryoplasty group (29.3% vs. 55.8%, p=0.01; odds ratio: 0.36, 95% confidence interval: 0.15 to 0.89).. Among diabetic patients undergoing implantation of nitinol self-expanding stents in the superficial femoral artery, post-dilation with cryoplasty balloon reduced binary restenosis compared to conventional balloon angioplasty. (Study Comparing Two Methods of Expanding Stents Placed in Legs of Diabetics With Peripheral Vascular Disease [COBRA]; NCT00827853).

Topics: Aged; Alloys; Angioplasty, Balloon; Cryosurgery; Female; Femoral Artery; Follow-Up Studies; Humans; Intermittent Claudication; Male; Middle Aged; Pilot Projects; Plastic Surgery Procedures; Prospective Studies; Prosthesis Design; Stents; Treatment Outcome; Ultrasonography, Doppler, Color

To evaluate mid-term primary patency of the femoral artery stenting in correlation with usCRP level and characteristics of the population, morphological aspect of the lesions and interventional techniques.. Patients were prospectively included in a multicenter study (18 centers in France) after stenting (SMART, Cordis Johnson & Johnson, Issy-les-Moulineaux, France) of the superficial femoral artery (SFA). Inclusion and exclusion criteria were based on recommendations and every day practice of the centers.. Thus 255 patients (183 men; mean age: 69 years; range 44-92) were included. Technical success of the SFA stenting was 100% without any complications and primary angiographic success 97%. usCRP level increased significantly (p < 0.05) between before and 24h after SFA stenting. In the subgroup of patients without initial inflammation (n = 157), usCRP increased significantly (p < 0.05) in the group of patient with initial thrombosis and additional intervention (graft, amputation, angioplasty on other arterial bed) in the same procedure compared to the remaining patients. Restenosis rate was 12.4% (26/209 patients) at 7 ± 2 months. Before stenting, usCRP level was not predictive of a restenosis, whereas after stenting, an increase of the 24h usCRP level was significantly higher in the subgroup of patient with an occlusion at mid-term (8 patients; p < 0.05).. This study demonstrated good patency at 7 months of SFA stenting with nitinol SMART with an increase of the usCRP level 24h after stenting in favour of the presence of an occlusion at mid-term follow-up.

Topics: Adult; Aged; Aged, 80 and over; Alloys; Angiography; Angioplasty; Arterial Occlusive Diseases; C-Reactive Protein; Female; Follow-Up Studies; Humans; Intermittent Claudication; Ischemia; Leg; Magnetic Resonance Angiography; Male; Middle Aged; Prospective Studies; Prosthesis Failure; Recurrence; Risk Factors; Stents; Thrombosis; Tomography, X-Ray Computed; Vascular Patency

Recent randomized trials investigating stent implantation compared with balloon angioplasty for treatment of superficial femoral artery (SFA) disease have given divergent results in short (mean 5 cm) and intermediate (mean 10 cm) lesions. We reinvestigated whether primary nitinol stenting is associated with a morphologic and clinical benefit when compared with percutaneous transluminal angioplasty with optional stenting (PTA) in intermediate-length lesions.. We randomly assigned 73 patients with severe claudication or chronic limb ischemia and average 8 cm long (range 3-20 cm) SFA stenosis or occlusion to primary stent implantation (n = 34) or PTA (n = 39). Restenosis >50% and clinical outcome were assessed at 3, 6, and 12 months postintervention.. Average length of the treated segments was 98 + or - 54 mm and 71 + or - 43 mm in the stent and PTA groups (P = 0.011), respectively. In the PTA group, secondary stenting was performed in 10 of 39 patients (26%) due to a suboptimal result after balloon dilation. Restenosis rates in the stent and PTA groups were 21.9% versus 55.6% (P = 0.005) at 6 months by CT-angiography, and 2.9% versus 18.9% (P = 0.033), 18.2% versus 50.0% (P = 0.006), and 34.4% versus 61.1% (P = 0.028) at 3, 6, and 12 months by sonography, respectively. Clinically, patients in the stent group reported a significantly higher maximum walking capacity compared with the PTA group at 6 and 12 months.. In this randomized multicenter trial, primary stenting with a self-expanding nitinol stent for treatment of intermediate length SFA disease resulted morphologically and clinically superior midterm results compared with balloon angioplasty with optional secondary stenting.

Topics: Aged; Alloys; Angiography, Digital Subtraction; Angioplasty, Balloon; Arterial Occlusive Diseases; Austria; Constriction, Pathologic; Female; Femoral Artery; Humans; Intermittent Claudication; Ischemia; Male; Middle Aged; Prospective Studies; Prosthesis Design; Recovery of Function; Recurrence; Stents; Time Factors; Tomography, X-Ray Computed; Treatment Outcome; Ultrasonography, Doppler, Color; Vascular Patency; Walking

The purpose of this study was to evaluate the long-term results of iliac artery stent placement with use of the symphony stent for the treatment of patients with intermittent claudication. In a prospective study, 31 cases of iliac occlusive arterial disease were treated in 26 patients. Stenoses (n = 27) were treated after failed angioplasty, and occlusions (n = 4) were treated with primary stent placement. Clinical history, clinical stage and the ankle brachial-index (ABI) examination measurement were assessed. The patients were followed up with clinical examination, ABI examination measurement and intravenous angiography. The follow-up period ranged between 9.5 months and 7.5 years (median = 5.9 yr). Data were analyzed using the univariate analysis (Kaplan-Meier method). The mean+/-SD ABI pre-, post-procedure and in the last control was 0.70+/-0.17, 0.97+/-0.15, and 0.96+/-0.20, respectively. Primary patency rates (%) +/- SE were 83+/-7 after 3 years, 75+/-8 after five years, and 67+/-9 after seven years, and secondary patency rates were 93+/-5 after three years, 86+/-7 after five years, and 86+/-7 after seven years. During the first 24 hours, one patient presented occlusion of the treated segment. During follow-up, 9 (29%) patients were admitted to our hospital because of worsening of the symptoms. In this study, the symphony stent has been proven to be a good device to treat lesions in the iliac region but more experience is needed to optimize endovascular treatment in this area. In our experience the treatment of iliac artery occlusive disease with symphony stents can be considered a good option with acceptable patency rates and low morbidity and mortality.

Topics: Adult; Aged; Alloys; Angiography, Digital Subtraction; Angioplasty, Balloon; Arterial Occlusive Diseases; Arteriosclerosis Obliterans; Constriction, Pathologic; Female; Follow-Up Studies; Humans; Iliac Artery; Intermittent Claudication; Kaplan-Meier Estimate; Male; Middle Aged; Prospective Studies; Stents; Vascular Patency

Because stent implantation for disease of the superficial femoral artery has been associated with high rates of late clinical failure, percutaneous transluminal angioplasty is preferred for endovascular treatment, and stenting is recommended only in the event of suboptimal technical results. We evaluated whether primary implantation of a self-expanding nitinol (nickel-titanium) stent yielded anatomical and clinical benefits superior to those afforded by percutaneous transluminal angioplasty with optional secondary stenting.. We randomly assigned 104 patients who had severe claudication or chronic limb ischemia due to stenosis or occlusion of the superficial femoral artery to undergo primary stent implantation (51 patients) or angioplasty (53 patients). Restenosis and clinical outcomes were assessed at 6 and 12 months.. The mean (+/-SD) length of the treated segment was 132+/-71 mm in the stent group and 127+/-55 mm in the angioplasty group. Secondary stenting was performed in 17 of 53 patients (32 percent) in the angioplasty group, in most cases because of a suboptimal result after angioplasty. At 6 months, the rate of restenosis on angiography was 24 percent in the stent group and 43 percent in the angioplasty group (P=0.05); at 12 months the rates on duplex ultrasonography were 37 percent and 63 percent, respectively (P=0.01). Patients in the stent group were able to walk significantly farther on a treadmill at 6 and 12 months than those in the angioplasty group.. In the intermediate term, treatment of superficial-femoral-artery disease by primary implantation of a self-expanding nitinol stent yielded results that were superior to those with the currently recommended approach of balloon angioplasty with optional secondary stenting. (ClinicalTrials.gov number, NCT00281060.).

Topics: Aged; Alloys; Angioplasty, Balloon; Female; Femoral Artery; Follow-Up Studies; Humans; Intermittent Claudication; Ischemia; Leg; Logistic Models; Male; Middle Aged; Peripheral Vascular Diseases; Recurrence; Statistics, Nonparametric; Stents; Ultrasonography

To report our experience in treating severely claudicant patients, employing a "nitinol-constrained" balloon (Chocolate, TriReme Medical Inc., Pleasanton, CA-USA) before drug-coated balloon (DCB) in a standardized protocol.. Eighty-one (84 limbs) consecutive Rutherford category (RC) 3 patients treated between December 2014 and December 2016 for superficial femoral artery (SFA) and popliteal arterial (PA) disease by nitinol-constrained balloon followed by DCB were enrolled. Bailout stenting was performed by Zilver PTX implantation. Intraoperative technical success and bailout-stenting rates were assessed as well as clinical improvement, ankle-brachial index (ABI) modification, primary patency (PP), and secondary patency (SP) rates at follow-up.. Sixty-eight patients (83.9%) were male and 31 (38.2%) diabetics. Fifty-five limbs (65.5%) presented occlusion (CTO); in 18 limbs CTO was longer than 150 mm. Bailout stenting rate was 9.5% (8/84). All patients completed 30-day follow-up: PP 100%, 61 patients completely asymptomatic (RC = 0). Mean follow-up was 12.3 ± 5.6 months; overall PP was 98.8%, and SP was 98.8%. At mid-term analysis, no differences in outcomes were recorded between stenosis and CTOs with a PP of 96.5 and 96%, respectively (p = 0.725). CTO length impacted early results: in cases of CTOs < 150 mm, PP was 100%, while in CTOs > 150 mm, it was 83.3% (p = 0031). ABI at 12-month was significantly higher with respect to preoperative values (p < 0.001).. In this preliminary experience, our protocol seems to be safe and effective in treating SFA and PA lesions in claudicant patients with satisfactory early and 12-month results.

Topics: Aged; Alloys; Angioplasty, Balloon; Ankle Brachial Index; Catheters; Female; Femoral Artery; Humans; Intermittent Claudication; Male; Popliteal Artery; Prospective Studies; Retrospective Studies; Stents; 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 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

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

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

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

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

Deep venous stenting has become the primary treatment option for chronic venous obstructive disease, both for iliac vein compression and post-thrombotic venous lesions. Until recently, only stents aimed at arterial pathology were used, because no dedicated venous stents were available. However, three such stents have now become available. These venous stents are characterized by increased length, diameter, flexibility, and radial force. This study reports an early experience with one of these devices; the sinus Venous stent (OptiMed GmbH, Ettlingen, Germany).. Between March 2012 and July 2014, 75 patients were treated with the sinus Venous stent: 35 cases of iliac vein compression syndrome and 40 cases of unilateral chronic obstruction in post-thrombotic syndrome (PTS). Diagnosis of relevant obstruction was made using clinical evaluation, duplex ultrasound, and magnetic resonance venography. Patency during follow up was assessed with duplex ultrasound. Clinical improvement was assessed by VCSS, Villalta score, rate of ulcer healing, and improvement of venous claudication.. The cumulative patency rates at 3, 6, and 12 months were 99%, 96%, and 92%, respectively. The cumulative assisted primary patency rates were 99% at 3, 6, and 12 months. The cumulative secondary patency rate at 12 months was 100%. Differences exist in patency rate between the subgroups of non-thrombotic and post-thrombotic, with the first showing no re-occlusions. All re-thromboses in the PTS group were treated by ancillary treatment modalities. VCSS and Villalta score decreased significantly after stenting, as did venous claudication. Morbidity was low without clinically relevant pulmonary embolism, and mortality was nil. Although two out of seven ulcers healed temporarily, no ulcer remained healed at 12 months follow up.. Short-term clinical results using the sinus Venous stent are excellent, with significant symptom reduction, low morbidity rates, and no mortality. Loss of stent patency is seen less often compared with arterial stents described in the literature.

Topics: Adolescent; Adult; Aged; Alloys; Angioplasty, Balloon; Chronic Disease; Female; Humans; Iliac Vein; Intermittent Claudication; Kaplan-Meier Estimate; Leg Ulcer; Magnetic Resonance Angiography; Male; May-Thurner Syndrome; Middle Aged; Netherlands; Phlebography; Postthrombotic Syndrome; Prosthesis Design; Recurrence; Stents; Tertiary Care Centers; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Duplex; Vascular Patency; Wound Healing; Young Adult

A 74-year-old woman complained of claudication due to in-stent restenosis of bare-metal stents in the right superficial femoral artery, and two Zilver PTXs were deployed. However, hemarthrosis developed, and aspirin and clopidogrel were discontinued. Thirty-six days later, she suddenly felt rest pain in her right leg. Angiography revealed total occlusion at the Zilver PTX implantation site, demonstrating late stent thrombosis. Aspiration and thrombolysis yielded adequate flow and symptom resolution. Follow-up catheterization was scheduled 6 months later. While the Zilver PTX stents were angiographically patent, angioscopy demonstrated a large red thrombus and uncovered stent struts. Therefore, dual antiplatelet therapy was continued.

Topics: Aged; Alloys; Angiography; Angioscopy; Antineoplastic Agents, Phytogenic; Drug-Eluting Stents; Female; Femoral Artery; Follow-Up Studies; Graft Occlusion, Vascular; Humans; Intermittent Claudication; Paclitaxel; Prosthesis Failure; Thrombosis; Time Factors

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

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

Popliteal artery stenting is not routinely performed due to concerns related to the high mobility of the knee joint and the potential for external stent compression, fractures, and occlusion. Open bypass is traditionally considered the gold standard for popliteal artery atherosclerotic lesions. The Supera stent (IDEV Technologies Inc, Webster, Tex) was developed to provide superior radial strength, fracture resistance, and flexibility compared with laser-cut nitinol stents. This study represents the initial United States experience in the management of popliteal 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 Trans-Atlantic Inter-Society Consensus criteria. Patency and limb loss rates were calculated using Kaplan-Meier analysis.. A total of 39 stents were placed in 34 patients due to isolated popliteal artery occlusive disease. 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, 0-26.8 months). Most patients had critical limb ischemia (CLI), with tissue loss (38.2%) or rest pain (35.3%) as the indication for intervention. In 20 patients (58.8%), the most distal end of the stent(s) landed in the below-the-knee popliteal segment, 12 (35.3%) landed in the above-the-knee segment, and two (5.9%) landed precisely at the knee. Other than angioplasty and stenting, 47% of patients did not receive any adjuvant concomitant therapy in the treated leg. Two patients underwent concomitant atherectomy of the popliteal segment. Primary, primary assisted, and secondary patency rates by duplex ultrasound imaging were 79.2%, 88.1% and 93%, respectively, by Kaplan-Meier estimates, with a mean stented length of 12 cm. Six instances of stent occlusion were noted, and six patients were identified with hemodynamically significant in-stent stenosis. Three patients sustained limb loss (8.8%), two related to uncontrolled infections, and one due to perioperative ischemic complications (both with patent stents at the time of limb loss). The overall mortality was 8.8% during the study period. Knee roentgenography was performed in all but one patient, and no stent fractures were identified.. Stenting of the popliteal artery 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 highly diseased patient population justify a prospective trial in this subject.

Topics: Aged; Aged, 80 and over; Alloys; Amputation, Surgical; Angioplasty; Atherosclerosis; Critical Illness; Female; Hemodynamics; Humans; Intermittent Claudication; Ischemia; Kaplan-Meier Estimate; Male; Middle Aged; Multivariate Analysis; Popliteal Artery; Proportional Hazards Models; Prosthesis Design; Radiography; Retrospective Studies; Risk Factors; Stents; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Duplex; United States; 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

Topics: Alloys; Angioplasty, Balloon; Arterial Occlusive Diseases; Female; Femoral Artery; Humans; Intermittent Claudication; Male; Popliteal Artery; Stents

To evaluate efficacy, safety, and midterm patency of a helical, self-expanding nitinol stent after failed percutaneous transluminal angioplasty (PTA) of popliteal artery segments P1 and P2 in patients with chronic critical limb ischemia (CLI) or lifestyle-limiting claudication.. Between February 2009 and March 2011, 40 patients (23 men; mean age 77±10 years) classified as Rutherford category 3 (n = 10) or 4/5 (n = 30) underwent PTA of the proximal and mid popliteal artery followed by implantation of a SUPERA stent for elastic recoil, residual stenosis, or flow-limiting dissection. All patients had an elevated operative risk. Before and after the procedure and during the 12-month follow-up, a clinical investigation, ankle-brachial-index (ABI) measurement, and color-coded duplex sonography and/or digital subtraction angiography were performed. Primary endpoints were limb salvage and anatomical patency at 12 months.. Stent implantation was successful in all patients. The major complication rate was 7.5% (an access-site pseudoaneurysm, 2 retroperitoneal hematomas, and 1 death from retroperitoneal bleeding). Mean follow-up was 15.9 months (range 0.5-27.9). The mean baseline ABI of 0.37 significantly increased to 0.91 at 12 months (p<0.01). Three (7.5%) patients underwent bypass surgery owing to lack of clinical improvement (<0.10 improvement in ABI). Primary and secondary patency rates at 12 months in the 34 patients eligible for follow-up were 68.4% and 79.8%, respectively. The major amputation rate was 5% at 1 year. Five (12.5%) in-stent stenoses and 1 of 2 (5.0%) in-stent occlusions were successfully recanalized (the second occlusion was asymptomatic).. Implantation of this helical stent into segments of the popliteal artery at the knee joint in CLI patients is a safe and clinically effective bailout method with acceptable intermediate patency.

Topics: Aged; Aged, 80 and over; Alloys; Angiography, Digital Subtraction; Angioplasty, Balloon; Ankle Brachial Index; Arterial Occlusive Diseases; Constriction, Pathologic; Critical Illness; Female; Germany; Humans; Intermittent Claudication; Ischemia; Kaplan-Meier Estimate; Limb Salvage; Lower Extremity; Magnetic Resonance Angiography; Male; Middle Aged; Popliteal Artery; Prosthesis Design; Retrospective Studies; Risk Assessment; Risk Factors; Stents; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Color; Vascular Patency

Topics: Alloys; Angioplasty, Balloon; Cryosurgery; Female; Femoral Artery; Humans; Intermittent Claudication; Male; Plastic Surgery Procedures; Stents

To evaluate the safety and efficacy of the Misago self-expanding rapid-exchange nitinol stent system for the treatment of femoropopliteal occlusive disease in a prospective multicenter observational trial (ClinicalTrials.gov; identifier NCT01118117).. Between April and October 2008, the registry enrolled 744 patients (496 men; 69 ± 10 years) who had symptomatic ≥ 70% stenosis or occlusion of the superficial femoral or popliteal arteries treated with the Misago stent. Mean length of the 750 lesions was 63.9 mm; 282 (37.6%) vessels were completely occluded. Primary study endpoints were the need for target lesion revascularization (TLR) and event-free survival rates for the assessment of efficacy and safety, respectively. At 6 and 12 months post intervention, clinical symptoms of recurrent ischemia and/or claudication, Rutherford category, and ankle-brachial index (ABI) at rest were assessed.. In the study period, 945 stents were successfully deployed in the 750 lesions. The overall TLR rate was 10.1% among 671 (90.3%) patients evaluated at 1 year [3.1% among 709 (95.3%) patients at 6 months]. Event-free survival at 12 months was 84.9%. Mean ABIs improved by ≥ 0.1 in three quarters of the patients (76.0%) over 12 months. The Rutherford grade improved or remained stable in the majority of patients (95.5%) after 1 year. Stent fractures (13 grade 1, 2 grade 2) in 3.1% of stents examined radiographically (n=484) at 1 year were not related to any clinical events. Primary patency was recorded in 574 (87.6%) patients evaluated at 1 year post procedure.. The Misago rapid-exchange nitinol stent showed promising efficacy and safety results, with a low stent fracture rate, in patients with femoropopliteal disease, making it a safe and reliable treatment option.

Topics: Aged; Alloys; Arterial Occlusive Diseases; Chi-Square Distribution; Chile; Constriction, Pathologic; Disease-Free Survival; Endovascular Procedures; Europe; Female; Femoral Artery; Humans; Intermittent Claudication; Ischemia; Israel; Life Tables; Male; Middle Aged; Popliteal Artery; Prospective Studies; Prosthesis Design; Radiography; Recurrence; Registries; Severity of Illness Index; Stents; Time Factors; Treatment Outcome; Vascular Patency

Topics: Alloys; Arterial Occlusive Diseases; Endovascular Procedures; Female; Femoral Artery; Humans; Intermittent Claudication; Ischemia; Male; Popliteal Artery; Stents

A 66-year-old man was treated for disabling right leg calf claudication with angioplasty and stenting of a chronically occluded superficial femoral artery. During attempted subintimal passage, the guidewire tracked extralumenally, which was not recognized, but it was successfully redirected into the true lumen distal to the occlusion with the use of the Outback (Cordis Endovascular, Miami Lakes, Fla) re-entry device. A bare metal nitinol stent was initially deployed extralumenally in the perivascular soft tissue. The patient returned for reintervention 9 days later complaining of pain and discoloration of the popliteal space. Duplex evaluation of the superficial femoral artery revealed a pseudoaneurysm, and Viabahn stent grafts (W. L. Gore & Assoc, Flagstaff, Ariz) were successfully deployed to produce an endovascular percutaneous prosthetic bypass.

Topics: Aged; Alloys; Aneurysm, False; Angioplasty, Balloon; Arterial Occlusive Diseases; Blood Vessel Prosthesis; Blood Vessel Prosthesis Implantation; Chronic Disease; Constriction, Pathologic; Femoral Artery; Humans; Intermittent Claudication; Male; Prosthesis Design; Stents; Treatment Outcome; Ultrasonography, Doppler, Duplex

Over the last decade, the number of endovascular procedures performed on the superficial femoral (SFA) and popliteal arteries (PA) has significantly increased. There is no consensus on the optimal form of intervention used in this arterial segment. While some have advocated balloon angioplasty alone, others have championed either selective or primary stenting of these lesions. It is the purpose of this study to determine the efficacy and durability of primary stenting of the superficial femoral and popliteal artery.. All patients undergoing peripheral angioplasty by a single vascular surgeon were prospectively enrolled in an Institutional Review Board-approved, primary-stenting protocol. During a 44-month period, all patients undergoing percutaneous transluminal angioplasty of the SFA or PA also received primary arterial stenting with bare, self-expanding nitinol stents. Patient demographics and risk factors were identified. TransAtlantic InterSociety Consensus (TASC) classifications were determined for all lesions. Loss of primary patency was said to have occurred when an occlusion or a 50% or greater stenosis in any treated arterial segment was diagnosed by arterial duplex or angiography. Only time to loss of primary patency was recorded. Kaplan-Meier survival curves were plotted and differences between groups tested by log rank method.. Between January 16, 2004 and August 13, 2007, 201 angioplasties with primary stenting were performed on 161 patients. One hundred twenty-three stents were placed for claudication, and 78 for critical limb ischemia. Forty-six segments treated were TASC A, 82 were TASC B, 38 were TASC C, and 35 were TASC D. Patient follow-up ranged from three to 1329 days (mean: 426 days). Primary patency rates for TASC A and B lesions were 79%, 67%, and 57% at 12, 24, and 36 months. For TASC C and D lesions, primary patency rates were 52.7%, 36%, and 19% at the same time intervals. Primary patency rates for TASC A and B lesions were significantly higher than for C and D lesions (P < .001). The limb salvage rate was 88.5% in patients with critical limb ischemia. Distal runoff did not influence patency (P = .827).. Primary stenting of the SFA and PA provides durable results in patients with TASC A and B lesions and may be an effective treatment strategy. This approach is significantly less effective when used in treating those with TASC C and D disease. Based on the results in this series, the use of primary stenting does not extend the anatomic limits of the current treatment recommendations for catheter-based intervention in patients with infrainguinal occlusive disease.

Topics: Adult; Aged; Aged, 80 and over; Alloys; Angioplasty, Balloon; Arterial Occlusive Diseases; Constriction, Pathologic; Female; Femoral Artery; Humans; Intermittent Claudication; Ischemia; Kaplan-Meier Estimate; Male; Middle Aged; Patient Selection; Popliteal Artery; Proportional Hazards Models; Prospective Studies; Prosthesis Design; Radiography; Risk Assessment; Risk Factors; Stents; Time Factors; Treatment Outcome; Ultrasonography; Vascular Patency

Topics: Alloys; Angioplasty, Balloon; Arterial Occlusive Diseases; Constriction, Pathologic; Femoral Artery; Humans; Intermittent Claudication; Ischemia; Popliteal Artery; Prosthesis Design; Risk Assessment; Risk Factors; Stents; Time Factors; Treatment Outcome; Vascular Patency

Topics: Alloys; Angioplasty, Balloon; Arterial Occlusive Diseases; Constriction, Pathologic; Femoral Artery; Humans; Intermittent Claudication; Ischemia; Prosthesis Design; Stents; Treatment Outcome; Vascular Patency

To evaluate our initial experience with hypogastric artery occlusion using a nitinol vascular plug during endovascular aortic aneurysm repair (EVAR).. We reviewed the records and images of 23 consecutive patients who underwent transluminal vessel occlusion of the hypogastric artery with a nitinol plug, as well as a cohort of 19 patients who underwent hypogastric artery embolization with coils in conjunction with EVAR.. There were no demographic differences between the two groups of patients. Hypogastric artery occlusion was successful in all cases when a nitinol vascular plug was used. When coils were used, there was one unsuccessful embolization which required a second procedure. The number of embolic devices used in the coil group was 7.53 (range, three to 13) compared with 1.35 (range, one to six) in the plug group (P < .05). Only one plug was used in 19 of 23 cases. The average cost to embolize per hypogastric artery was $1,496 compared with $470 when a nitinol plug was used. There were two instances of coil migration. No other intraoperative complications occurred. At one month follow up, seven patients (35%) in the coil group complained of buttock claudication compared with two patients (9%) in the nitinol plug group (P = .027).. Our experience demonstrates the safety and effectiveness of the nitinol vascular plug for hypogastric artery occlusion during EVAR. When compared with coils for hypogastric embolization during EVAR, nitinol vascular plugs are less expensive, produce less technical complications, and are associated with a significantly lower incidence of gluteal claudication.

Topics: Aged; Alloys; Aortic Aneurysm; Blood Vessel Prosthesis Implantation; Buttocks; Embolization, Therapeutic; Equipment Design; Female; Hospital Costs; Humans; Iliac Aneurysm; Intermittent Claudication; Ischemia; Male; Medical Records; Time Factors; Tomography, X-Ray Computed; Treatment Outcome

A recent randomized trial suggested nitinol self-expanding stents (SES) were associated with reduced restenosis rates compared with simple percutaneous transluminal angioplasty (PTA). We evaluated our results with superficial femoral artery (SFA) SES to determine whether TransAtlantic InterSociety Consensus (TASC) classification, indication for intervention, patient risk factors, or Society of Vascular Surgery (SVS) runoff score correlated with patency and clinical outcome, and to evaluate if bare nitinol stents or expanded polytetrafluoroethylene (ePTFE) covered stent placement adversely impacts the tibial artery runoff.. A total of 109 consecutive SFA stenting procedures (95 patients) at two university-affiliated hospitals from 2003 to 2006 were identified. Medical records, angiographic, and noninvasive studies were reviewed in detail. Patient demographics and risk factors were recorded. Procedural angiograms were classified according to TASC Criteria (I-2000 and II-2007 versions) and SVS runoff scores were determined in every patient; primary, primary-assisted, secondary patency, and limb salvage rates were calculated. Cox proportional hazard model was used to determine if indication, TASC classification, runoff score, and comorbidities affected outcome.. Seventy-one patients (65%) underwent SES for claudication and 38 patients (35%) for critical limb ischemia (CLI). Average treatment length was 15.7 cm, average runoff score was 4.6. Overall 36-month primary, primary-assisted, and secondary rates were 52%, 64%, and 59%, respectively. Limb salvage was 75% in CLI patients. No limbs were lost following interventions in claudicants (mean follow-up 16 months). In 24 patients with stent occlusion, 15 underwent endovascular revision, only five (33%) ultimately remained patent (15.8 months after reintervention). In contrast, all nine reinterventions for in-stent stenosis remained patent (17.8 months). Of 24 patients who underwent 37 endovascular revisions for either occlusion or stenosis, eight (35%) had worsening of their runoff score (4.1 to 6.4). By Cox proportional hazards analysis, hypertension (hazard ratio [HR] 0.35), TASC D lesions (HR 5.5), and runoff score > 5 (HR 2.6) significantly affected primary patency.. Self-expanding stents produce acceptable outcomes for treatment of SFA disease. Poorer patency rates are associated with TASC D lesions and poor initial runoff score; HTN was associated with improved patency rates. Stent occlusion and in-stent stenosis were not entirely benign; one-third of patients had deterioration of their tibial artery runoff. Future studies of SFA interventions need to stratify TASC classification and runoff score. Further evaluation of the long-term effects of SFA stenting on tibial runoff is needed.

Topics: Alloys; Amputation, Surgical; Angioplasty, Balloon; Arizona; Arterial Occlusive Diseases; Female; Femoral Artery; Humans; Intermittent Claudication; Ischemia; Limb Salvage; Male; Polytetrafluoroethylene; Popliteal Artery; Proportional Hazards Models; Prosthesis Design; Radiography; Regional Blood Flow; Reoperation; Retrospective Studies; Risk Assessment; Severity of Illness Index; Stents; Tibial Arteries; Time Factors; Treatment Failure; Treatment Outcome; Vascular Patency

We describe a case of symptomatic common femoral artery stenosis following use of a vascular clip closure device (StarClose). Operative repair was performed, with removal of the clip device and subsequent vein patch angioplasty.

Topics: Adult; Alloys; Angioplasty; Arterial Occlusive Diseases; Constriction, Pathologic; Coronary Angiography; Device Removal; Equipment Design; Female; Femoral Artery; Hemorrhage; Hemostatic Techniques; Humans; Intermittent Claudication; Punctures

Topics: Alloys; Angioplasty; Arterial Occlusive Diseases; Constriction, Pathologic; Coronary Angiography; Device Removal; Equipment Design; Evidence-Based Medicine; Femoral Artery; Hemorrhage; Hemostatic Techniques; Humans; Intermittent Claudication; Patient Selection; Punctures; Risk Assessment

This analysis proposes safety and performance goals for prospective single-arm trials of bare nitinol stents to treat patients with debilitating claudication associated with femoropopliteal (FP) atherosclerotic lesions.. To date there have been no analyses of clinical trials data to set efficacy and safety benchmarks for new bare nitinol stents in the treatment of claudication from FP disease. Industry has been reluctant to sponsor studies of nitinol stents due to logistical barriers.. VIVA Physician's, Inc. (VPI) analyzed subject-level data from the PTA control arm of three randomized FDA device trials conducted by industry. Subjects with Rutherford category 2-4 claudication and FP lesion lengths 4-15 cm with 12 month duplex ultrasound (DUS) assessment were identified. These data were combined with the results of a survey of the medical literature (1990-2006) for similar subjects.. Analysis of the industry derived control arm PTA data identified 116 patients (mean lesion length 8.7 cm) with a 12 month DUS defined FP patency of 28%. A similar cohort of 191 patients was identified from the medical literature in which the 12-month vessel patency equaled 37%; from these combined patient cohorts, expected vessel patency for PTA was estimated to equal 33%.. Based on the PTA performance efficacy rate of 33% derived from industry clinical trial data and the medical literature, and the requirement that the bare nitinol stent 12-month efficacy performance goal be set to equal twice this rate, the patency efficacy goal equals 66%. Additional information is provided on safety and other reporting standards and stent integrity evaluation for bare metal stents.

Topics: Alloys; Angioplasty, Balloon; Atherosclerosis; Clinical Trials as Topic; Endpoint Determination; Femoral Artery; Guidelines as Topic; Humans; Intermittent Claudication; Peripheral Vascular Diseases; Popliteal Artery; Prospective Studies; Randomized Controlled Trials as Topic; Registries; Research Design; Sample Size; Severity of Illness Index; Stents; Treatment Outcome; Vascular Patency; Vascular Surgical Procedures

To evaluate the primary success and short-term patency associated with a new 4-F sheath-compatible self-expanding nitinol stent after failed conventional angioplasty of distal popliteal and infrapopliteal lesions in severe lifestyle-limiting claudication (LLC) and chronic critical limb ischemia (CLI).. Between May 2003 and July 2005, 35 patients with Rutherford category 3-5 disease (16 patients with CLI, 19 patients with LLC) underwent percutaneous transluminal angioplasty (PTA) and stent implantation. Indications for stent placement were residual stenosis, flow-limiting dissections, or elastic recoil after PTA. Before and after the intervention and during the 6-month follow-up, clinical investigation, color-flow and duplex Doppler ultrasonography, and digital subtraction angiography were performed. Technical success, primary patency at 6 months, clinical improvement as defined by Rutherford with clinical and hemodynamic measures, and complications were evaluated.. A total of 22 patients underwent distal popliteal artery stent placement and 13 underwent tibioperoneal artery stent placement. Stent implantation was successfully performed in all patients. After stent placement, the primary cumulative patency rate for the study group at 6 months was 82%. The mean resting ankle-brachial index at baseline was 0.50 +/- 0.16 and significantly increased to 0.90 +/- 0.17 at 12-24 hours after intervention and 0.82 +/- 0.24 at latest follow-up (P < .001 for both). The sustained clinical improvement rate was 80% at the 6-month follow-up. The 6-month limb salvage rate regarding major amputation was 100%. The rate of major complications was 17%.. Infrapopliteal application of the new nitinol stent is a safe, feasible, and effective method with good short-term patency rate in the treatment of severe LLC and chronic CLI.

Topics: Aged; Aged, 80 and over; Alloys; Angiography, Digital Subtraction; Angioplasty; Angioplasty, Balloon; Critical Illness; Feasibility Studies; Female; Follow-Up Studies; Humans; Intermittent Claudication; Ischemia; Kaplan-Meier Estimate; Laser-Doppler Flowmetry; Limb Salvage; Lower Extremity; Male; Middle Aged; Peripheral Vascular Diseases; Popliteal Artery; Prosthesis Design; Retrospective Studies; Severity of Illness Index; Stents; Tibial Arteries; Time Factors; Treatment Failure; Treatment Outcome; Ultrasonography, Doppler, Color; Vascular Patency

Endovascular treatments are becoming more beneficial in the treatment of complex peripheral arterial disease. We report a novel case of using a y-stenting technique at 2 bifurcation sites in the femoropopliteal region, to revascularize a long native SFA occlusion after failed femoropopliteal bypass grafting.

Topics: Alloys; Anastomosis, Surgical; Angioplasty, Balloon; Arterial Occlusive Diseases; Blood Vessel Prosthesis Implantation; Combined Modality Therapy; Female; Femoral Artery; Fibrinolytic Agents; Humans; Intermittent Claudication; Middle Aged; Popliteal Artery; Prosthesis Design; Recurrence; Stents; Thrombectomy; Thrombolytic Therapy; Tomography, X-Ray Computed; Treatment Failure; Ultrasonography, Doppler, Color; Urokinase-Type Plasminogen Activator

Topics: Alloys; Angioplasty, Balloon; Confounding Factors, Epidemiologic; Femoral Artery; Humans; Intermittent Claudication; Ischemia; Leg; Peripheral Vascular Diseases; Research Design; Stents

Subintimal angioplasty is a simple and safe alternative to conventional intraluminal angioplasty for the recanalization of diffuse long femoropopliteal occlusions. However, long-term patency rates are unsatisfactory despite the high initial technical success rates. Two cases of occluded left superficial femoral arteries are presented in which subintimal angioplasty with proximal stent implantation was successfully performed. Self-expanding nitinol stents were placed at the proximal part of subintimal plane to maintain good inflow. In both cases, follow-up angiogram at 6 months demonstrated patent stents with good antegrade flow.

Topics: Aged; Alloys; Angioplasty, Balloon; Arterial Occlusive Diseases; Blood Vessel Prosthesis Implantation; Coated Materials, Biocompatible; Coronary Stenosis; Femoral Artery; Humans; Intermittent Claudication; Male; Middle Aged; Popliteal Artery; Radiography; Stents; Tunica Intima

Topics: Alloys; Angioplasty, Balloon; Arterial Occlusive Diseases; Blood Vessel Prosthesis Implantation; Coated Materials, Biocompatible; Coronary Stenosis; Femoral Artery; Humans; Intermittent Claudication; Popliteal Artery; Radiography; Stents; Tunica Intima

To document a preliminary study to assess the deployment and outcomes of endoluminal stent grafting in the superficial femoral artery (SFA) with use of a prototype device.. Twenty patients with lifestyle-limiting intermittent claudication were selected for treatment with a balloon-mounted expansive polytetrafluoroethylene graft. All patients had angiographically proven SFA disease (median length, 17 cm) with normal arterial inflow and at least two calf vessels patent to the ankle. Follow-up was by means of ankle brachial pressure index (ABPI), duplex ultrasound, and angiography.. Fourteen patients were successfully treated. Six patients were excluded: five by the study protocol and one because the procedure was a technical failure. ABPI rose from 0.6 before treatment to 1.0. The treated limbs became asymptomatic. Twelve-month primary, primary assisted, and secondary patency rates of treated patients were 29%, 50%, and 64%.. Endovascular stent grafting of SFA lesions is technically feasible, but the patency rates obtained with this design are inferior to those obtained with conventional surgical bypass.

Topics: Aged; Alloys; Angiography, Digital Subtraction; Biocompatible Materials; Blood Vessel Prosthesis Implantation; Female; Femoral Artery; Follow-Up Studies; Humans; Intermittent Claudication; Male; Middle Aged; Polytetrafluoroethylene; Postoperative Complications; Prosthesis Design; Secondary Prevention; Stents; Treatment Outcome; Ultrasonography, Interventional

Our objective was to compare intravascular sonography with digital subtraction angiography (DSA) in the assessment of luminal dimension and morphologic features of endovascular stents and stent grafts.. Thirty-seven pelvic and 24 femoral stents (12 Wall-stents; 27 covered and 22 uncovered nitinol stents) in 50 patients were evaluated 15 +/- 10 months after implantation by DSA and intravascular sonography. The degree of maximum instent restenosis as revealed by DSA and intravascular sonography was compared for each location. Morphologic features of the stents and stenoses were also assessed.. Intravascular sonography and DSA correlated well (R2 = .96) in determining in-stent restenosis. In-stent restenosis was underestimated by 13% +/- 6% by DSA compared with intravascular sonography. Differences in determining in-stent restenosis with intravascular sonography and DSA were not associated with severity of stenosis or type of stent. Intravascular sonography revealed incomplete expansion of stents in 21 cases, whereas DSA revealed incomplete expansion of stents in seven cases. The intra- and interobserver variabilities in our study were 4% and 5%, respectively.. In-stent restenoses are underestimated with DSA. Intravascular sonography is superior to DSA for detection of incomplete stent expansion.

Topics: Alloys; Angiography, Digital Subtraction; Ankle; Arterial Occlusive Diseases; Arteriosclerosis; Blood Pressure; Blood Vessel Prosthesis; Blood Vessel Prosthesis Implantation; Brachial Artery; Evaluation Studies as Topic; Female; Femoral Artery; Graft Occlusion, Vascular; Humans; Intermittent Claudication; Male; Middle Aged; Observer Variation; Pelvis; Peripheral Vascular Diseases; Prosthesis Design; Recurrence; Regression Analysis; Sensitivity and Specificity; Stents; Surface Properties; Ultrasonography, Interventional