nitinol and Arterial-Occlusive-Diseases

Treatment of superficial femoral artery (SFA) lesions remains challenging. We conducted a network meta-analysis of randomized controlled trials aiming to explore the efficacy of treatment modalities for SFA "de novo" lesions.. Eleven treatments for SFA occlusive disease were recognized. We used primary patency and binary restenosis at 12-month follow-up as proxies of efficacy for the treatment of SFA lesions.. A total of 33 studies (66 study arms; 4659 patients) were deemed eligible. In terms of primary patency, odds ratios (ORs) with 95% confidence intervals (CIs) were statistically significantly higher in drug-eluting stent (DES; OR, 10.05; 95% CI, 3.22-31.39), femoropopliteal bypass surgery (BPS; OR, 7.15; 95% CI, 2.27-22.51), covered stent (CS; OR, 3.56; 95% CI, 1.33-9.53), and nitinol stent (NS; OR, 2.83; 95% CI, 1.42-5.51) compared with balloon angioplasty (BA). The rank order from higher to lower primary patency in the multidimensional scaling was DES, BPS, NS, CS, drug-coated balloon, percutaneous transluminal angioplasty with brachytherapy, stainless steel stent, cryoplasty (CR), and BA. Combination therapy of NS with CR and drug-coated balloon were the two most effective treatments, followed by NS, CS, percutaneous transluminal angioplasty with brachytherapy, cutting balloon, stainless steel stent, BA, and CR in terms of multidimensional scaling values for binary restenosis.. DES has shown encouraging results in terms of primary patency for SFA lesions, whereas BPS still maintains its role as a principal intervention. On the contrary, BA and CR appear to be less effective treatment options.

Topics: Alloys; Angioplasty, Balloon; Arterial Occlusive Diseases; Brachytherapy; Cardiovascular Agents; Coated Materials, Biocompatible; Constriction, Pathologic; Cryotherapy; Drug-Eluting Stents; Endovascular Procedures; Femoral Artery; Humans; Network Meta-Analysis; Odds Ratio; Prosthesis Design; Randomized Controlled Trials as Topic; Recurrence; Risk Factors; Stents; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency; Vascular Surgical Procedures

In this article we wanted to present an overview of the latest study results, in vitro and in vivo, of the Covered Endovascular Reconstruction of the Aortic Bifurcation or CERAB technique and the C-CERAB or Chimney CERAB for the endovascular treatment of either extensive occlusive aortoiliac or iuxtarenal disease with preservation of visceral arteries; in combination with tips and tricks to facilitate recanalization and revascularization. A review was performed of the literature of the last 5 years regarding the endovascular treatment of aortoiliac and iuxtarenal TASC II C& D lesions with covered balloon expandable stents. Furthermore we did a retrospective analysis of our most special techniques to achieve a successful interventional recanalization of these challenging lesions. Both the in vitro and the in vivo studies pointed out that there exists an important benefit of the CERAB configuration with excellent patency rates at one and two years in combination with very low mortality and morbidity, when compared to other techniques. Also the C-CERAB variant seems to be a feasible and safe option; 100% technical success; to deal with iuxtarenal or extensive aortic occlusive disease together with the safeguarding of visceral arteries. The CERAB and C-CERAB techniques may change the treatment algorithm of extensive aortoiliac occlusive disease in the near future and appears to be a safe and feasible alternative with promising results, together with a more anatomical and physiological reconstruction of the aortic bifurcation, being a valid alternative for surgery and/or kissing stents. A few critical issues still need to be solved, such as cost-effectiveness, patient selection, fine-tuning of the technique and defining the optimal medical support.

Topics: Alloys; Aorta, Abdominal; Aortic Diseases; Arterial Occlusive Diseases; Blood Vessel Prosthesis Implantation; Cost-Benefit Analysis; Endovascular Procedures; Equipment Design; Humans; Iliac Artery; In Vitro Techniques; Patient Selection; Stents; Vascular Patency

A significant subset of patients with peripheral artery disease (PAD) has iliac artery involvement that requires treatment. The development of bare metal stents has improved the short- and long-term outcomes of endovascular repair and has become first line therapy. Open surgical bypass has been reserved for extremely complex anatomic morphologies or endovascular failures. It is unclear whether primary stenting is superior to angioplasty with provisional stenting but if angioplasty is used alone, it is likely only appropriate for the most focal lesions. Self-expanding and balloon-expandable stents have unique characteristics that are suitable to different lesion morphologies. Both stent-types have demonstrated similar outcomes. Herein, we review the practice and results of bare metal stents in the iliac arteries.

Topics: Alloys; Angioplasty; Arterial Occlusive Diseases; Blood Vessel Prosthesis Implantation; Endovascular Procedures; Humans; Iliac Aneurysm; Metals; Peripheral Vascular Diseases; Stents

This article reviews current knowledge and applications of drug-eluting devices in the treatment of peripheral arterial disease. The authors briefly report on the performance of plain old balloon angioplasty and bare metal stents in femoro-popliteal and below-the-knee lesions. This article explains the rationale behind the development of drug-eluting devices and describes the main technical features of currently available drug-eluting stents and drug-coated balloons. Dedicated sections discuss the results of trials investigating the potential benefits of these devices used in femoro-popliteal and infra-popliteal arterial vascular beds. Finally, ongoing studies and potential novel applications of drug-eluting technologies in other vascular beds are mentioned.

Topics: Alloys; Angioplasty, Balloon; Arterial Occlusive Diseases; Drug-Eluting Stents; Evidence-Based Medicine; Femoral Artery; Humans; Ischemia; Leg; Metals; Popliteal Artery; Stents; Treatment Outcome

To evaluate the effectiveness of the Viabahn stent-graft in the treatment of superficial femoral artery (SFA) occlusive disease.. A systematic review and meta-analysis of published studies was performed to evaluate the efficacy of the Viabahn for SFA lesions. Studies were stratified according to controlled vs uncontrolled design and analyzed using random-effects models. Outcomes are reported as the risk ratio (RR) and 95% confidence interval (CI). Four prospective randomized controlled trials, one retrospective controlled study, and 9 uncontrolled studies were identified.. In controlled studies, primary patency with the Viabahn was superior to other interventions at 1 year (RR 0.63, 95% CI 0.49 to 0.82, p<0.001) and ankle-brachial index (ABI) improvement was greater at 6 months (mean difference 0.05, 95% CI 0.01 to 0.09, p=0.01) compared with other interventions. Subgroup analysis demonstrated a lower incidence of stent fracture in lesions with >15-cm stented lengths. In uncontrolled studies, ABI improvement was consistently superior at all measurement points during follow-up.. Current evidence suggests that the Viabahn stent-graft is a safe and effective option for symptomatic SFA lesions. Prospective multicenter randomized controlled trials with long-term follow-up are needed to confirm the sustained efficacy of the Viabahn device.

Topics: Alloys; Arterial Occlusive Diseases; Blood Vessel Prosthesis; Femoral Artery; Humans; Polytetrafluoroethylene; Prosthesis Design; Stents; Vascular Patency

Significant advances have been made in femoropopliteal stent design and clinical outcomes during the past decade. Initial randomized studies demonstrated superiority of nitinol self-expanding stents to balloon angioplasty for treatment of moderate-length superficial femoral artery stenoses. During longer-term follow-up, first generation nitinol stents were hampered by high rates of stent fracture. A number of newer nitinol stent designs have been developed with improved conformability, greater radial strength and lower rates of long-term stent fracture. These newer stent designs have demonstrated superior primary patency and decreased restenosis for the treatment of moderate-length femoropopliteal lesions relative to historical benchmarks. Recent advances in drug-eluting nitinol stents have also offered treatment options for challenging lesion subsets including very long femoropopliteal lesions and for the treatment of in-stent restenosis. This article reviews recent advances and upcoming research in nitinol self-expanding stent technology for the treatment of superficial femoral and popliteal artery stenosis.

Topics: Alloys; Arterial Occlusive Diseases; Equipment Design; Femoral Artery; Humans; Popliteal Artery; Prosthesis Design; Randomized Controlled Trials as Topic; Stents; Treatment Outcome

The aim of this paper was to evaluate the efficacy of a novel 4-F compatible self-expanding Nitinol stent for the treatment of long femoro-popliteal obstructions.. This retrospective analysis includes patients with femoro-popliteal obstructions ≥ 120 mm in length, treated with a novel Nitinol stent (Pulsar-18) between February 2010 and December 2011. Patients were categorized as either intermittent claudication (IC) or critical limb ischemia (CLI). Primary endpoint was primary patency, secondary endpoints were target lesion revascularization (TLR).. A total of 31 patients (IC: N=18 and CLI: N=13) were included in the present series. Mean age was 73.3 ± 10.1 years and 71% (22/31) of the patients were male. Primary intervention was performed in 77.4% (24/31) of the patients and re-do revascularization in the remaining. Mean lesion length of femoro-popliteal obstructions was 163.5 ± 32.5 mm. Technical success was obtained in all patients. Mean follow-up duration was 316 ± 198 days. Primary patency rates were 83.3% in IC and 80.0% in CLI patients at 6 months and 64.1% and 54.9% at 12 months, respectively (P=0.84). Target lesion revascularization occurred in 5.6% of IC and 20.0% of CLI patients at 6 months and in 14.1% and 36.0% at 12 months, respectively (P=0.43).. Endovascular stenting of long femoro-popliteal lesions using the Pulsar-18 stent provides acceptable results with patency and restenosis rates comparable with data from literature for stenting of long femoro-popliteal obstructions.

Topics: Aged; Aged, 80 and over; Alloys; Angioplasty, Balloon; Arterial Occlusive Diseases; Catheters; Constriction, Pathologic; Equipment Design; Female; Femoral Artery; Humans; Male; Middle Aged; Popliteal Artery; Prosthesis Design; Recurrence; Retrospective Studies; Stents; Time Factors; Treatment Outcome; Vascular Patency

To determine the efficacy and safety of balloon angioplasty (BA) with optional stenting vs. routine stenting with current open cell nitinol stents for femoropopliteal occlusive disease by analyzing the overall results from all available randomized controlled trials.. A bibliographic search of electronic medical databases (MEDLINE, Embase, ISI Web of Knowledge, and the Cochrane Central Register of Controlled Trials) was conducted to identify relevant articles from 1960 to July 2011. Of the 701 published articles retrieved, 17 clinical trials randomized patients with symptomatic femoropopliteal occlusive disease to either primary BA or primary stenting. Of these, 4 RCTs involved the use of currently employed high flexibility nitinol stents. Thirteen other trials that employed obsolete, steel, or coated stents were excluded. The technical success rate, the target lesion revascularization (TLR) rate, and the binary restenosis rate at 12 months were primary efficacy endpoints; mortality was the primary safety endpoint. The results are reported as the odds ratio (OR) with 2-tailed 95% confidence intervals (95% CI).. The study population was made up of 627 patients (416 men; mean age 67±10 years) and 665 lesions (361 assigned to the primary stenting and 304 to BA). The mean length of the treated lesion was similar in both groups (74.6±45.7 mm in the stenting group vs. 66.7±41.3 mm in the BA group). Technical success was significantly higher in the stenting group compared to BA (95.8% vs. 64.2%; OR 0.31, 95% CI 0.09 to 0.92, p<0.001). Follow-up ranged from 12 to 24 months. Based on 3 studies, the TLR at 12 months favored the stent group (OR 2.47, 95% CI 0.72 to 8.49, p=0.065), but the difference did not reach statistical significance. However, the 12-month binary restenosis rate was significantly lower in the primary stenting group (OR 3.02, 95% CI 1.3 to 6.71, p<0.001). With respect to the safety endpoint, mortality was similar in both groups (OR 0.83, 95% CI 0.39 to 1.77, p<0.001).. This meta-analysis supports the use of the primary stenting, mainly for long lesions, as a first-line endovascular treatment for symptomatic disease in the femoropopliteal segment, contrary to indications for use in current clinical guidelines.

Topics: Aged; Alloys; Angioplasty, Balloon; Arterial Occlusive Diseases; Constriction, Pathologic; Evidence-Based Medicine; Female; Femoral Artery; Humans; Male; Middle Aged; Odds Ratio; Popliteal Artery; Prosthesis Design; Randomized Controlled Trials as Topic; Recurrence; Risk Factors; Stents; Time Factors; Treatment Outcome

Infrainguinal peripheral occlusive disease is increasingly being treated by endovascular techniques. Bare metal stainless steel, self-expanding nitinol stents, drug-eluting and covered stents (stent grafts) are becoming increasingly more important adjuncts to percutaneous translumninal angioplasty in the treatment of peripheral artery disease. In this article the available evidence supporting the use of stents in the femoropopliteal and tibial arteries will be described as well as their limitations. Future stent developments will also be discussed.

Topics: Alloys; Angiography; Angioplasty, Balloon; Arterial Occlusive Diseases; Coated Materials, Biocompatible; Drug-Eluting Stents; Equipment Design; Equipment Failure; Humans; Ischemia; Recurrence; Stainless Steel; Stents

The 1- to 2-year primary patency rates associated with self-expanding nitinol stents for the treatment of symptomatic femoropopliteal disease are superior to those for percutaneous transluminal angioplasty (PTA) and the first-generation stainless steel balloon-expandable stents. The advantages of nitinol stents include improved radial strength and flexibility, the ability to recover from being crushed, reduced foreshortening, and (importantly) deployability without balloon dilation of the stent edge (which may decrease the incidence of the edge stenosis, or "candy-wrap" effect, often observed with balloon-expandable stents). The technical success rate associated with primary deployment of nitinol stents is very high, and acute to 6-month patency results are predictably excellent. Prior to the introduction of nitinol stents, the original guidelines (2000) of the multidisciplinary TransAtlantic Inter-Society Consensus (TASC I) recommended only an adjunctive role for femoropopliteal stents following suboptimal PTA. The abbreviated 2007 TASC II report essentially extended this recommendation to nitinol stents. Here, current trials of nitinol stenting in the femoropopliteal segment are discussed, with emphasis on the advantages of primary (and often direct) deployment in selected circumstances dependent on factors including lesion length, lesion location, indication for treatment (critical limb ischemia or claudication, in-stent restenosis, stent-graft restenosis), and the relative appropriateness of other modalities (e.g., covered stents). Technical considerations in primary nitinol stenting are briefly reviewed. Open questions regarding the factors involved in nitinol stent fracture and the possible association of fracture and restenosis are examined in the context of current clinical trials. A new generation of femoropopliteal nitinol stents combining superior durability and flexibility is expected soon. Development and implementation of uniform reporting and surveillance standards is important for optimizing current and future research.

Topics: Alloys; Angioplasty, Balloon; Arterial Occlusive Diseases; Constriction, Pathologic; Femoral Artery; Humans; Popliteal Artery; Practice Guidelines as Topic; Prosthesis Design; Prosthesis Failure; Radiography; Recurrence; Risk Assessment; Stents; Time Factors; Treatment Outcome; Vascular Patency

Despite technical advances in balloon design and technique, there has been little improvement of primary patency rates after balloon-based endovascular interventions for all but focal femoropopliteal lesions. Improving on stainless steel models, nitinol stents have been associated with favorable short- and midterm primary patency rates; studies with longer-term follow-up will be required to learn whether restenosis is ongoing, with continued loss of primary patency. Studies in recent years have shown varying incidences of mechanical fatigue leading to nitinol stent fracture. Covered stents are designed to prevent the tissue infiltration and intimal hyperplasia that can lead to bare metal in-stent restenosis. Several clinical studies, mainly single-center registries, have demonstrated a general effectiveness of the Hemobahn/Viabahn polytetrafluoroethylene-covered stent-grafts, approved for femoral arterial occlusive disease, and have helped to distinguish indications for use and to delineate possible failure modes. A multicenter randomized trial, which has completed enrollment, will compare the Viabahn with self-expanding bare nitinol stents. The primary use of drug-eluting stents (DES) has become routine clinical practice for coronary artery disease. The 2-phase multicenter randomized double-blind SIROCCO trials have been completed, with results published through 24 months. Follow-up demonstrated the feasibility and safety of deploying sirolimus-eluting stents in the femoropopliteal segment but failed to show superior efficacy for DES versus bare nitinol stents. However, the restenosis rates with bare metal stents were unexpectedly low. A paclitaxel-eluting stent without a polymer coating is currently being evaluated in the recently enrolled Zilver PTX randomized trial and international registry. A polymer-based everolimus-eluting stent is being evaluated for femoropopliteal use in the nonrandomized European STRIDES trial. Balloons coated with paclitaxel have recently been evaluated for simple femoropopliteal disease with encouraging results through 2 years of follow-up. The bioabsorbable stent concept emerged in response to the potential issues with metal stents, but to date no investigational device has successfully overcome issues such as relatively low radial force and variable degradation rates.

Topics: Alloys; Angioplasty, Balloon; Arterial Occlusive Diseases; Blood Vessel Prosthesis; Blood Vessel Prosthesis Implantation; Constriction, Pathologic; Drug-Eluting Stents; Femoral Artery; Humans; Metals; Multicenter Studies as Topic; Polytetrafluoroethylene; Popliteal Artery; Prosthesis Design; Prosthesis Failure; Randomized Controlled Trials as Topic; Recurrence; Stents; Time Factors; Treatment Outcome; Vascular Patency

Endovascular stent implantation was introduced to femoropopliteal procedures almost two decades ago. Initial results with balloon-expandable stainless steel stents and self expanding Elgiloy stents, however, were disappointing. In particular, recurrence rates after long-segment femoropopliteal stenting were rather high, in the range of 60% to 80% at 1 year. After years of stagnation, recent developments in femoropopliteal stent technology have been promising. Self-expanding nitinol stents have been evaluated in several prospective studies. Initial problems with stent fractures seem to be resolved using second-generation devices. The second generation of Nitinol stents have an enhanced flexibility particularly also in axial direction due to a reduction of cell interconnections and a more spiral orientation of the interconnections. However, until now there is no proof of any impact of the stent design on restenosis rate. Otherwise, stenting has been shown to be beneficial compared to balloon angioplasty especially in longer femoropopliteal lesions. The superior fracture resistance of the latest stent generation in combination with the production of long nitinol stents of up to 20 cm in length allow that more difficult and complex lesions can be treated endovascularly. The main unresolved problem with femoropopliteal stenting is the treatment of instent restenosis. Future concepts to further improve long-term patency after femoropopliteal stenting are therefore under investigation, including drug-eluting stents (DES), biodegradable stents, and coated stent-grafts. Stent grafts appear to be a viable option for the treatment of complex superficial femoral artery lesions, with comparable outcomes to prosthetic above-knee femoropopliteal bypass surgery. Concerning DES, we have to wait for the results of the ongoing studies.

Topics: Aged; Alloys; Angioplasty, Balloon; Arterial Occlusive Diseases; Blood Vessel Prosthesis; Blood Vessel Prosthesis Implantation; Coated Materials, Biocompatible; Constriction, Pathologic; Drug-Eluting Stents; Femoral Artery; Humans; Male; Popliteal Artery; Prosthesis Design; Prosthesis Failure; Radiography; Recurrence; Stents; Treatment Outcome

Infrainguinal occlusive disease is a complex problem necessitating the cooperation of both medical and surgical therapies to aid limb salvage and alleviate symptoms. Endovascular therapies are varied, with no treatment clearly outweighing the other in terms of efficacy and durability. Angioplasty for focal stenosis has gained ground as the treatment of choice when indicated. There has also been a rapid evolution in stent technology, from early stainless steel wall stents to today's drug eluting nitinol stents. In this article, we examine the literature on these new technologies and treatment options and make recommendations based on the best data available.

Topics: Alloys; Angioplasty, Balloon; Arterial Occlusive Diseases; Drug-Eluting Stents; Humans; Immunosuppressive Agents; Inguinal Canal; Sirolimus; Stents; Treatment Outcome; Vascular Patency

The superficial femoral artery (SFA) is a unique vessel in terms of its anatomy, its function and its interventional requirements; it has no comparison in any other arterial vascular bed. It is a long conduction vessel with a high flow resistance underlying several different hemodynamic conditions. In the past 15 years the unique characteristics of the SFA have resulted in poor interventional outcomes, with mid-term restenosis rates in the order of 50%--outcomes that are worse than in any other arterial vascular bed. In view of the clinical importance of SFA treatment, which comprises about 50% of all interventions at peripheral arterial lesions, considerable efforts have been made with a variety of interventional techniques to achieve progress. Only the use of self-expanding nitinol stents appears to improve the mid-term results of catheter-based interventional SFA treatment.

Topics: Alloys; Angiography; Anti-Bacterial Agents; Arterial Occlusive Diseases; Catheterization; Femoral Artery; Follow-Up Studies; Humans; Immunosuppressive Agents; Multicenter Studies as Topic; Randomized Controlled Trials as Topic; Retrospective Studies; Sirolimus; Stents; Time Factors; Tomography, X-Ray Computed; Treatment Outcome

Restenosis after percutaneous transluminal angioplasty (PTA) of the superficial femoral artery (SFA) may occur in 45% of patients at 2 years follow-up. Paclitaxel-coated balloons have been found to reduce neointimal hyperplasia, and thus reduce restenosis. Recently, the Legflow(®) paclitaxel-coated balloon (Cardionovum Sp.z.o.o., Warsaw, Poland) (LPEB) has been introduced. This balloon is covered with shellac, a Food and Drug Administration (FDA) approved natural resin, to obtain an equally distributed tissue concentration of paclitaxel. The RAPID trial is designed to assess restenosis after PTA using the Legflow balloon combined with nitinol stenting versus uncoated balloons with nitinol stenting in SFA lesions >5 cm.. A total of 176 adult patients with Rutherford class 2 to class 6 symptoms due to intermediate (5-15 cm) or long (>15 cm) atherosclerotic lesions in the SFA will be randomly allocated for treatment with LPEB with nitinol stenting or uncoated balloon angioplasty with stenting. Stenting will be performed using the Supera(®) stent in both groups (IDEV Technologies Inc., Webster, TX). The primary endpoint is the absence of binary restenosis of the treated SFA segment. Secondary outcomes are target lesion revascularization (TLR), clinical and hemodynamic outcome, amputation rate, mortality rate, adverse events, and device-specific adverse events. Follow up consists of four visits in which ankle-brachial indices (ABI), toe pressure measurements, and duplex ultrasound (DUS) will be performed. Furthermore, a peripheral artery questionnaire (PAQ) will be completed by the patients at each follow-up. In the event that DUS reveals a symptomatic >50% restenosis, or a >75% asymptomatic restenosis, additional digital subtraction angiography will be performed with any necessary re-intervention.. The RAPID trial is a multicenter randomized controlled patient blind trial that will provide evidence concerning whether the use of the Legflow paclitaxel/shellac coated balloons with nitinol stenting significantly reduces the frequency of restenosis in intermediate and long SFA lesions compared to standard PTA and stenting.. ISRCTN47846578.

Topics: Alloys; Amputation, Surgical; Angiography, Digital Subtraction; Angioplasty, Balloon; Ankle Brachial Index; Arterial Occlusive Diseases; Cardiovascular Agents; Clinical Protocols; Coated Materials, Biocompatible; Constriction, Pathologic; Equipment Design; Equipment Failure; Femoral Artery; Hemodynamics; Humans; Hyperplasia; Limb Salvage; Neointima; Netherlands; Paclitaxel; Predictive Value of Tests; Prosthesis Design; Prosthesis Failure; Recurrence; Research Design; Resins, Plant; Single-Blind Method; Stents; Surveys and Questionnaires; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Duplex; Vascular Access Devices

The predominant mode of bare nitinol stent failure is diffuse in-stent restenosis, and failure rates correlate to the length and complexity of the treated lesion. Addition of an expanded polytetrafluoroethylene lining to a nitinol stent frame, as found in the VIABAHN endoprosthesis, mitigates the ingrowth of intimal hyperplasia. We compared the long-term outcomes of complex superficial femoral artery disease intervention using the VIABAHN endoprosthesis to those obtained with bare nitinol stent implantation.. One hundred forty-eight patients with symptomatic complex superficial femoral artery disease (TransAtlantic Inter-Society Consensus I class C and D lesions, accompanied by intermittent claudication or ischemic rest pain) were randomized to endovascular intervention using either bare nitinol stent implantation (76 patients) or nonheparin-bonded VIABAHN endoprosthesis deployment (72 patients). Patency, limb hemodynamics, and quality of life were evaluated at 1, 6, 12, 24, and 36 months following intervention.. The average treated lesion measured 18 ± 8 cm in length, and 58.8% of lesions displayed segmental or complete occlusion. At 3 years, primary patency rates (defined by peak systolic velocity ratio ≤ 2.0 and no target lesion revascularization) did not significantly differ between patients treated with the VIABAHN stent graft and those who received a bare nitinol stent (24.2% vs 25.9%; P = .392). Stent fractures were significantly more common in bare nitinol stents (50.0%) than in the VIABAHN endoprostheses (2.6%). Primary-assisted patency rates were higher in those receiving bare nitinol stents than the VIABAHN stent graft (88.8% vs 69.8%; P = .04), although secondary patency rates did not differ between bare nitinol stent and stent graft recipients (89.3% vs 79.5%; P = .304). There were no instances of procedure-related mortality or amputation. The hemodynamic improvement and quality measures improved equally in both groups.. The long-term outcomes of complex superficial femoral artery disease intervention using the VIABAHN endograft and bare nitinol stents are similar. Although primary patency rates are low in both study arms, excellent primary-assisted and secondary patency rates were achieved, with sustained augmentation of limb perfusion and quality-of-life measures. Patency rates diminish most rapidly in the first year after device implantation.

Topics: Adult; Aged; Aged, 80 and over; Alloys; Arterial Occlusive Diseases; Blood Vessel Prosthesis; Blood Vessel Prosthesis Implantation; Constriction, Pathologic; Endovascular Procedures; Female; Femoral Artery; Graft Occlusion, Vascular; Hemodynamics; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Polytetrafluoroethylene; Prosthesis Design; Prosthesis Failure; Quality of Life; Stents; Time Factors; Treatment Outcome; United States; Vascular Patency

Stenting has been shown to improve patency after femoral artery revascularization compared with balloon angioplasty. Limited data are available evaluating endovascular treatment for obstructive lesions of the popliteal artery.. This prospective, randomized, multicenter trial compared primary nitinol stent placement to percutaneous transluminal balloon angioplasty in patients with peripheral artery disease Rutherford-Becker class 2 to 5 who had a de novo lesion in the popliteal artery. The primary study end point was 1-year primary patency, defined as freedom from target-lesion restenosis (luminal narrowing of ≥50%) as detected by duplex ultrasound. Secondary end points included target-lesion revascularization rate and changes in Rutherford-Becker class. Provisional stent placement was considered target-lesion revascularization and loss of primary patency. Two hundred forty-six patients were included in this trial. The mean target-lesion length was 42.3 mm. One hundred ninety-seven patients were available for the1-year follow-up. The 1-year primary patency rate was significantly higher in the group with primary nitinol stent placement (67.4%) than in the percutaneous transluminal balloon angioplasty group (44.9%, P=0.002). Target-lesion revascularization rates were 14.7% and 44.1%, respectively (P=0.0001); however, when provisional nitinol stent placement was not considered target-lesion revascularization and loss in patency, no significant differences prevailed between the study groups (67.4% versus 65.7%, P=0.92 for primary patency). Approximately 73% of patients in the percutaneous transluminal balloon angioplasty group and 77% in the nitinol stent group showed an improvement of ≥1 Rutherford-Becker class (P=0.31).. Primary nitinol stent placement for obstructive lesions of the popliteal artery achieves superior acute technical success and higher 1-year primary patency only if provisional stenting is considered target-lesion revascularization. Provisional stenting as part of a percutaneous transluminal balloon angioplasty strategy has equivalent 1-year patency and should be preferred over primary stenting.. http://www.clinicaltrials.gov. Unique identifier: NCT00712309.

Topics: Adult; Aged; Aged, 80 and over; Alloys; Angioplasty, Balloon; Arterial Occlusive Diseases; Endovascular Procedures; Female; Follow-Up Studies; Humans; Male; Middle Aged; Popliteal Artery; Prospective Studies; Stents; Survival Rate; Treatment Outcome; 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

This study investigated the results with primary stenting using the Protégé EverFlex 200-mm-long self-expanding nitinol stent (ev3 Endovascular Inc, Plymouth, Minn) in femoropopliteal TransAtlantic Inter-Society Consensus (TASC) C and D lesions of at least 150 mm in length.. Between March 2008 and June 2009, 100 patients (66 men) presenting with 100 symptomatic TASC C and D femoropopliteal lesions were treated with at least one 200-mm-long Protégé EverFlex stent. The intention of this study was to treat all lesions with as few stents as possible. The primary study end point was primary patency at 12 months, defined as the absence of hemodynamically significant stenosis on duplex ultrasound imaging (systolic velocity ratio <2.4) at the target lesion and without target lesion revascularization (TLR) ≤12 months. Stent fracture occurrence was assessed at the 12-month follow-up by conventional x-ray imaging.. Average patient age was 70 years. Preoperative symptom assessment reported 71 patients (71%) had claudication vs 29 (29%) with critical limb ischemia. Average lesion length was 242 mm (range, 160-450 mm), and 27 patients (27%) presented with popliteal involvement. A total of 158 Protégé EverFlex stents were used to treat 100 lesions. Kaplan-Meier estimation reported a 12-month freedom from target lesion revascularization of 68.2% and a primary patency rate of 64.8%. Stent fractures occurred in six patients (6.0%) when x-ray images taken immediately after the procedure were compared with those taken after 1 year.. The results of our Durability-200 study show an acceptable primary patency rate after 1 year was obtained in this patient cohort with TASC C and D femoropopliteal lesions.

Topics: Aged; Aged, 80 and over; Alloys; Angioplasty, Balloon; Ankle Brachial Index; Arterial Occlusive Diseases; Belgium; Constriction, Pathologic; Female; Femoral Artery; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Popliteal Artery; Prospective Studies; Prosthesis Design; Severity of Illness Index; Stents; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Duplex; Vascular Patency

To evaluate a newly developed self-expanding Misago (Terumo Corp., Tokyo, Japan) nitinol stent with rapid exchange delivery catheter for the treatment of stenotic or occluded superficial femoral (SF) or popliteal arteries.. MISAGO 1 clinical trial enrolled 55 patients undergoing percutaneous intervention of totally occluded or stenotic lesions in SF or popliteal arteries treated with the implantation of 81 stents in five centres across Europe. Primary endpoint was restenosis rate at six months assessed by duplex sonography. Patients (67% male) were 68+/-9 years old, 60% were smokers and 31% had diabetes. Clinical symptoms of ischaemia were present in all patients. Average lesion length was 85+/-50 mm, 64% were totally occluded and 38% classified as TASC C or D. The technical success rate was 100% while the procedural success rate was 98.2% without death, MI, stroke, or major bleeding. At six months follow-up the restenosis rate was 8.5%. One patient (1.8%) died of bronchial carcinoma and two (3.6%) underwent target vessel revascularisation. Mean ankle brachial index improved from 0.70 at baseline to 0.95 at six months while walking capacity on treadmill test improved with an average of 147 m. Rutherford index at six months demonstrated improvement of 72%, without any patients having symptom deterioration. One case of stent fracture was observed.. The results from this first-in-man study indicate good safety and short to medium term efficacy profile of the Misago nitinol stent.

Topics: Aged; Alloys; Arterial Occlusive Diseases; Blood Vessel Prosthesis; Europe; Female; Femoral Artery; Follow-Up Studies; Graft Occlusion, Vascular; Humans; Incidence; Male; Popliteal Artery; Retrospective Studies; Stents; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Duplex

Controversy still exists regarding the best endovascular treatment strategy for patients with symptomatic disease of the superficial femoral artery. There are conflicting data regarding the benefits of superficial femoral artery stenting and the role of primary stenting compared with balloon angioplasty with provisional stent implantation.. A total of 206 patients from 24 centers in the United States and Europe with obstructive lesions of the superficial femoral artery and proximal popliteal artery and intermittent claudication were randomized to implantation of nitinol stents or percutaneous transluminal angioplasty. The mean total lesion length was 71 mm for the stent group and 64 mm for the angioplasty group. Acute lesion success (<30%residual stenosis) was superior for the stent group compared with the angioplasty group (95.8% versus 83.9%; P<0.01). Twenty-nine (40.3%) patients in the angioplasty group underwent bailout stenting because of a suboptimal angiographic result or flow-limiting dissection. Bailout stenting was treated as a target lesion revascularization and loss of primary patency in the final analysis. At 12 months, freedom from target lesion revascularization was 87.3% for the stent group compared with 45.1% for the angioplasty group (P<0.0001). Duplex ultrasound-derived primary patency at 12 months was better for the stent group (81.3% versus 36.7%; P<0.0001). Through 12 months, fractures occurred in 3.1% of stents implanted. No stent fractures resulted in loss of patency or target lesion revascularization.. In this multicenter trial, primary implantation of a self-expanding nitinol stent for moderate-length lesions in the superficial femoral artery and proximal popliteal artery was associated with better acute angiographic results and improved patency compared with balloon angioplasty alone.. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00673985.

Topics: Aged; Alloys; Angiography; Angioplasty, Balloon; Arterial Occlusive Diseases; Drug-Eluting Stents; Europe; Female; Femoral Artery; Follow-Up Studies; Humans; Male; Middle Aged; Popliteal Artery; Prosthesis Implantation; Treatment Outcome; Ultrasonography, Doppler, Duplex; United States

This is a randomized prospective study comparing the treatment of superficial femoral artery occlusive disease percutaneously with an expanded polytetrafluoroethylene (ePTFE)/nitinol self-expanding stent graft (stent graft) versus surgical femoral to above-knee popliteal artery bypass with synthetic graft material.. One hundred limbs in 86 patients with superficial femoral artery occlusive disease were evaluated from March 2004 to May 2005. Patient symptoms included both claudication and limb threatening ischemia with or without tissue loss. Trans-Atlantic InterSociety Consensus (TASC II) A (n = 18), B (n = 56), C (n = 11), and D (n = 15) lesions were included. Patients were randomized prospectively into one of two treatment groups; a percutaneous treatment group (group A; n = 50) with angioplasty and placement of one or more stent grafts, or a surgical treatment group (group B; n = 50) with a femoral to above-knee popliteal artery bypass using synthetic conduit (Dacron or ePTFE). Patients were followed for 48 months. Follow-up evaluation included clinical assessment, physical examination, ankle-brachial indices, and color flow duplex sonography at 3, 6, 9, 12, 18, 24, 36, and 48 months.. Mean total lesion length of the treated arterial segment in the stent graft group was 25.6 cm (SD = 15 cm). The stent graft group demonstrated a primary patency of 72%, 63%, 63%, and 59% with a secondary patency of 83%, 74%, 74%, and 74% at 12, 24, 36, and 48 months, respectively. The surgical femoral-popliteal group demonstrated a primary patency of 76%, 63%, 63%, and 58% with a secondary patency of 86%, 76%, 76%, and 71% at 12, 24, 36, and 48 months, respectively. No statistical difference was found between the two groups with respect to primary (P = .807) or secondary (P = .891) patency.. Management of superficial femoral artery occlusive disease with percutaneous stent grafts exhibits similar primary patency at 4-year (48 month) follow up when compared with conventional femoral-popliteal artery bypass grafting with synthetic conduit. This treatment method may offer an alternative to treatment of the superficial femoral artery segment for revascularization when prosthetic bypass is being considered or when autologous conduit is unavailable.

Topics: Adult; Aged; Aged, 80 and over; Alloys; Angioplasty; Ankle Brachial Index; Arterial Occlusive Diseases; Blood Vessel Prosthesis; Blood Vessel Prosthesis Implantation; Constriction, Pathologic; Female; Femoral Artery; Graft Occlusion, Vascular; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Polyethylene Terephthalates; Polytetrafluoroethylene; Popliteal Artery; Prospective Studies; Prosthesis Design; Reoperation; Severity of Illness Index; Stents; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Color; United States; Vascular Patency

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

A randomized prospective study comparing the treatment of superficial femoral artery occlusive disease percutaneously with an expanded polytetrafluoroethylene (ePTFE)/nitinol self-expanding stent graft (stent-graft) vs surgical femoral to above knee popliteal artery bypass with synthetic graft material.. One hundred limbs in 86 patients with superficial femoral artery occlusive disease were evaluated from March 2004 to May 2005. Patient symptoms included both claudication and limb threatening ischemia with or without tissue loss. The TransAtlantic InterSociety Consensus (TASC) II A (N = 18), B (N = 56), C (N = 11), and D (N = 15) lesions were included. Patients were randomized prospectively into one of two treatment groups; a percutaneous treatment group (group A; N = 50) with angioplasty and placement of one or more stent-grafts or a surgical treatment group (group B; N = 50) with a femoral to above knee popliteal artery bypass using synthetic conduit (Dacron graft or ePTFE). Patients were followed for a total of 24 months. Follow-up evaluation included clinical assessment and physical examination, ankle-brachial indices (ABI), and color flow duplex sonography at 3, 6, 9, 12, 18, and 24 months.. The mean total lesion length of the treated arterial segment in the stent-graft group was 25.6 cm (SD +/- 15 cm). The stent-graft group demonstrated a primary patency of 81%, 72%, and 63% with a secondary patency of 86%, 83%, and 74% at 6, 12, and 24 months, respectively. The surgical femoral-popliteal group demonstrated a primary patency of 84%, 77%, and 64% with a secondary patency of 89%, 86%, and 76% at 6, 12, and 24 months, respectively. No statistical difference was found between the two groups with respect to primary (P = .716) or secondary patency (P = .695). Grouping of less severe (TASC II A/B) vs more severe (TASC II C/D) lesions demonstrated patency at 24 months for the femoral-popliteal arm of 63% and 67%, respectively while that of the stent-graft arm was 64% and 47%, respectively. Secondary patency was 76% in both TASC classifications for the femoral-popliteal arm with 78% and 47% patency found respectively in the stent-graft group. These resulted in no significant difference for primary (P = .978) or secondary (P = .653) patency overall, although there is a trend for decreased patency with higher TASC II lesions.. Management of superficial femoral artery occlusive disease with percutaneous stent-grafts exhibits similar primary patency at 24-month follow-up when compared with conventional femoral-popliteal artery bypass grafting with synthetic conduit. This treatment method may offer an alternative to treatment of the superficial femoral artery segment for revascularization when prosthetic bypass is being considered or when autologous conduit is unavailable.

Topics: Adult; Aged; Aged, 80 and over; Alloys; Angioplasty; Ankle; Arterial Occlusive Diseases; Blood Pressure; Blood Vessel Prosthesis; Blood Vessel Prosthesis Implantation; Brachial Artery; Femoral Artery; Humans; Middle Aged; Polyethylene Terephthalates; Polytetrafluoroethylene; Popliteal Artery; Prospective Studies; Prosthesis Design; Stents; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Color; 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

To compare the safety and effectiveness of the Viabahn endoprosthesis with that of percutaneous transluminal angioplasty (PTA) alone in the treatment of symptomatic peripheral arterial disease (PAD) affecting the superficial femoral artery (SFA).. From 1998 to 1999, patients with symptomatic SFA PAD were enrolled in a prospective, multicenter randomized study and underwent either PTA alone (n = 100) or PTA followed by stent-graft placement (expanded polytetrafluoroethylene/nitinol self-expanding stent-graft) (n = 97) for stenoses or occlusions of the SFA that were 13 cm long or shorter. At baseline, there were no significant differences between the PTA and stent-graft treatment groups, including chronic limb ischemia status and treated lesion length.. The stent-graft group had a significantly higher technical success rate (95% vs 66%, P < .0001) and 1-year primary vessel patency rate at duplex ultrasonography (65% vs 40%, P = .0003). A patency benefit was seen for lesions at least 3 cm long. At 12 months, chronic limb ischemia status was 15% further improved for the stent-graft group (P = .003). There were no significant differences between treatment groups with regard to the occurrence of early or late major adverse events.. In this multicenter study, the patency, technical success, and clinical status results obtained with stent-grafts were superior to those obtained with PTA alone.

Topics: Adult; Aged; Aged, 80 and over; Alloys; Angioplasty, Balloon; Arterial Occlusive Diseases; Blood Vessel Prosthesis; Coated Materials, Biocompatible; Female; Femoral Artery; Humans; Male; Middle Aged; Polytetrafluoroethylene; Prospective Studies; Prosthesis Design; Stents; Treatment Outcome; Vascular Patency

Primary stenting with self-expanding nitinol stents of the superficial femoral artery yielded improved morphological and clinical results compared with balloon angioplasty with optional stenting until 12 months in a randomized controlled trial. We now report 2-year data on restenosis and clinical outcomes of these patients.. Of 104 patients with chronic limb ischemia and superficial femoral artery obstructions, 98 (94%) could be followed up until 2 years after intervention for occurrence of restenosis (>50%) by duplex ultrasound and for clinical and hemodynamic outcome by treadmill walking distance and ankle brachial index. Restenosis rates at 2 years were 45.7% (21 of 46) versus 69.2% (36 of 52) in favor of primary stenting compared with balloon angioplasty with optional secondary stenting by an intention-to-treat analysis (P=0.031). Consistently, stenting (whether primary or secondary; n=63) was superior to plain balloon angioplasty (n=35) with respect to the occurrence of restenosis (49.2% versus 74.3%; P=0.028) by a treatment-received analysis. Clinically, patients in the primary stent group showed a trend toward better treadmill walking capacity (average, 302 versus 196 m; P=0.12) and better ankle brachial index values (average, 0.88 versus 0.78; P=0.09) at 2 years, respectively. Reintervention rates tended to be lower after primary stenting (17 of 46 [37.0%] versus 28 of 52 [53.8%]; P=0.14).. At 2 years, primary stenting with self-expanding nitinol stents for the treatment of superficial femoral artery obstructions yields a sustained morphological benefit and a trend toward clinical benefit compared with balloon angioplasty with optional stenting.

Topics: Aged; Alloys; Angioplasty, Balloon; Arterial Occlusive Diseases; Exercise Test; Female; Femoral Artery; Follow-Up Studies; Graft Occlusion, Vascular; Humans; Male; Middle Aged; Peripheral Vascular Diseases; Popliteal Artery; Stents; Treatment Outcome; Ultrasonography

To investigate whether primary nitinol stenting in the superficial femoral artery (SFA) is beneficial to patients' quality of life (QoL).. One hundred four patients (55 men; mean age 66+/-19 years) with chronic limb ischemia and SFA disease were randomly assigned to primary stent implantation (n=51) or balloon angioplasty (n=53) with optional stenting for a suboptimal angioplasty result (17 of 53). QoL was measured by the SF-36 questionnaire at baseline and at 3, 6, and 12 months post intervention.. QoL was significantly improved post intervention and up to 12 months in both treatment groups. Significant inverse associations were observed between QoL parameters and restenosis. Comparing primary stenting (n=51) versus balloon angioplasty with optional stenting (n=53) by the intention to treat, no significant differences in QoL were observed. Analyses of stented patients (n=68) versus balloon angioplasty (n=36) patients, however, demonstrated significantly improved measures of QoL after stenting.. Endovascular revascularization of SFA disease improves QoL, and restenosis negatively affects QoL outcomes. After stent implantation, whether primary or secondary, QoL was significantly ameliorated compared to balloon angioplasty alone. However, it remains to be proven in larger cohorts whether primary stenting yields a QoL benefit compared to balloon angioplasty with optional secondary stenting.

Topics: Aged; Alloys; Angioplasty, Balloon; Arterial Occlusive Diseases; Chronic Disease; Female; Femoral Artery; Health Status Indicators; Humans; Ischemia; Male; Middle Aged; Prospective Studies; Prosthesis Design; Quality of Life; Recovery of Function; Recurrence; Stents; Surveys and Questionnaires; Time Factors; Treatment Outcome; Vascular Surgical Procedures; Walking

To evaluate the effect of glycoprotein IIb/IIIa inhibition during nitinol stenting, of superficial femoral occlusive disease.. Stent implantation in the superficial femoral artery has been associated with suboptimal results while Glycoprotein IIb/IIIa inhibitors have shown improved procedural results during coronary intervention. We evaluated abciximab infusion during (Smart Stent) implantation in superficial femoral obstructions.. We conducted a randomized placebo controlled trial. The two primary end points include: (1) 9-month restenosis defined as a decrease in ankle brachial index and in-stent duplex ultrasound restenosis: (2) adverse events defined as death (30 days) or repeat revascularization within 9 months.. Twenty-seven patients were randomized to abciximab and 24 patients to control (placebo). The primary end point of cumulative restenosis occurred in 15.4% of patients administered abciximab and in 12% administered placebo (P = 0.873). The primary restenosis endpoint in diabetics and total occlusions were similar at 14.3% and 15.4% respectively. The composite end point of 30-day mortality and 9-month revascularization occurred in 5.8% abciximab and 0% (P = 0.274) placebo with no 30-day deaths. Graded treadmill time and Rutherford class were all significantly improved in both groups, but the abciximab group did not appear to demonstrate any identifiable effect.. (Smart Stent) nitinol stenting of the superficial femoral artery was associated with favorable functional outcomes at 9 months. Adjunctive abciximab did not appear to demonstrate any identifiable effect.

Topics: Abciximab; Aged; Aged, 80 and over; Alloys; Angiography; Angioplasty, Balloon; Antibodies, Monoclonal; Arterial Occlusive Diseases; Chi-Square Distribution; Female; Femoral Artery; Humans; Immunoglobulin Fab Fragments; Male; Middle Aged; Peripheral Vascular Diseases; Platelet Glycoprotein GPIIb-IIIa Complex; Stents; Treatment Outcome; Ultrasonography, Doppler, Duplex

To report a novel technique for safely closing antegrade common femoral artery (CFA) punctures using the StarClose device after proximal superficial femoral artery (SFA) angioplasty.. The vessel locator of the StarClose device should not be deployed within a recently dilated vessel, so after proximal SFA angioplasty, the sheath is withdrawn into the CFA. A second guidewire is inserted into the profunda femoris artery followed by insertion of the StarClose sheath. The vessel locator is deployed in the profunda main stem and withdrawn into the CFA until resistance is felt, indicating apposition to the luminal aspect of the vessel wall. The device is subsequently deployed according to the manufacturer's instructions.. Use of profunda femoris artery allows safe closure of the CFA using the StarClose device following antegrade puncture for proximal SFA angioplasty.

Topics: Alloys; Angiography; Angioplasty, Balloon; Arterial Occlusive Diseases; Femoral Artery; Hemorrhage; Hemostatic Techniques; Humans; Punctures

The StarClose Vascular Closure System (Abbott Vascular, Redwood City, CA) features a nitinol clip that is designed to achieve closure of the femoral arteriotomy access site. The CLIP Study was performed to assess the safety and efficacy of StarClose when compared with standard manual compression following 5-6 French diagnostic or interventional percutaneous procedures. A substudy of this trial was designed to assess the utility of duplex ultrasonography to assess patency of the femoral artery and to determine access site complications (pseudoaneurysm, arteriovenous fistula, hematoma, deep vein thrombosis) in a multicenter prospective trial. This is the report of the duplex ultrasound (DUS) substudy of the CLIP trial.. A total of 17 U.S. sites enrolled 596 subjects with 483 subjects randomized at a 2:1 ratio to receive StarClose or manual compression of the arteriotomy after a percutaneous procedure. The study included roll-in (n = 113), diagnostic (n = 208), and interventional (n = 275) arms with a primary safety endpoint of major vascular complications through 30 days and a primary efficacy endpoint of postprocedure time to hemostasis. A substudy of the CLIP interventional arm evaluated DUS images of the closure site at five study sites, targeting 100 subjects at day 30 following hemostasis. The DUS protocol was devised and implemented by an independent vascular ultrasound core laboratory with extensive experience in vascular device trials. DUS inguinal region from 6 cm proximal to 6 cm distal to the arteriotomy puncture was performed. A qualitative examination was performed to determine the presence of iatrogenic vascular injuries: hematoma, pseudoaneurysm (PSA), arteriovenous fistula (AVF), and arterial/venous thrombosis or stenosis using 2-dimensional gray scale, color, and focused Doppler images.. DUS of 96 subjects randomized to StarClose (n = 71) and compression (n = 25) were performed and evaluated. There was no evidence of hematoma, PSA, or AVF observed in the StarClose group. No StarClose subjects in the substudy had a PSA or AVF. All patients in the substudy demonstrated patency of the access site artery and vein without thrombosis or stenosis. Finally, in the entire study cohort, no clinically-driven DUS studies demonstrated iatrogenic vascular injury or vessel thrombosis in the StarClose treated patients.. DUS, a safe and reliable method for determining the safety and efficacy of access site closure devices, is a reliable, safe, inexpensive and accurate method of assessing vascular access site complications in multicenter trials. In this substudy of the CLIP study, DUS found no statistical difference in access site complications between the StarClose and manual compression groups. Both groups maintained vessel patency without stenosis, thrombosis, hematoma, pseudoaneurysm, or AV fistula.

Topics: Adult; Aged; Alloys; Aneurysm, False; Arterial Occlusive Diseases; Arteriovenous Fistula; Cardiac Catheterization; Collateral Circulation; Equipment Design; Equipment Safety; Female; Femoral Artery; Femoral Vein; Follow-Up Studies; Hematoma; Hemostasis; Hemostatic Techniques; Humans; Male; Middle Aged; Postoperative Complications; Prospective Studies; Reproducibility of Results; Saphenous Vein; Surgical Instruments; Treatment Outcome; Ultrasonography, Doppler, Duplex; Ultrasonography, Interventional; Vascular Patency; Venous Thrombosis

To investigate further the safety and efficacy of the sirolimus-eluting S. M.A.R.T. Nitinol Self-expanding Stent by comparison with a bare stent in superficial femoral artery (SFA) obstructions.. This randomized, double-blind study involved 57 patients (29 in the sirolimus-eluting stent group and 28 in the bare stent group) with chronic limb ischemia and SFA occlusions (66.7%) or stenoses (average lesion length, 81.5 mm +/- 41.2). Stent implantation followed standard interventional techniques and a maximum of two stents could be implanted. The primary endpoint was the in-stent mean lumen diameter at 6 months as determined by quantitative angiography.. Both stent types were effective in revascularizing the diseased SFA and allowing sustained patency for at least 6 months. There was no statistically significant difference between treatment groups in the in-stent mean lumen diameter at 6 months (4.94 mm +/- 0.69 and 4.76 mm +/- 0.54 mm for sirolimus-eluting and bare stent groups, respectively; P = .31). Although the diameter of the target lesion tended to be larger and percent stenosis tended to be lower with the sirolimus-eluting stent, there were no statistically significant differences between treatments in terms of any of the variables. The mean late loss values were 0.38 mm +/- 0.64 and 0.68 mm +/- 0.97 for the sirolimus-eluting stent group and the bare stent group, respectively (P = .20). The binary restenosis rates, with a cutoff of 50% at 6 months, were zero in the sirolimus-eluting stent group and 7.7% in the bare stent group (P = .49). Clinical outcomes matched angiographic outcomes with improvements in ankle-brachial index and symptoms of claudication. There was no significant difference between treatments in terms of adverse events.. Although there is a trend for greater efficacy in the sirolimus-eluting stent group, there were no statistically significant differences in any of the variables.

Topics: Aged; Alloys; Angiography; Arterial Occlusive Diseases; Double-Blind Method; Female; Femoral Artery; Graft Occlusion, Vascular; Humans; Immunosuppressive Agents; Leg; Male; Recurrence; Sirolimus; Statistics, Nonparametric; Stents; Treatment Outcome

To evaluate the technical performance, safety, and 1-year clinical efficacy of polytetrafluoroethylene (PTFE)-covered nitinol stents in the treatment of atherosclerotic iliac and superficial femoral artery (SFA) disease.. The multicenter, prospective, nonrandomized COVENT study involved 98 patients (70 men; mean age 64+/-10 years) who received PTFE-covered nitinol stents in 107 arteries (60 iliac and 47 SFAs) after predilation. The average lesion length was 50 mm in the SFA and 45 mm in the iliac arteries. Postdilation was performed when necessary. Duplex ultrasound and ankle-brachial index (ABI) were performed at discharge and at 1, 6, and 12 months in follow-up.. In total, 130 stents were placed successfully in 97 (99%) of 98 patients. One stent was misplaced during deployment and required subsequent surgical removal. The average stenosis grade was reduced from 98% to 6% in the SFAs and from 96% to 4% in the iliac arteries after covered stent placement. There was a significant rise of the mean ABI from 0.64 at baseline to 0.97 and 0.95 at 1 and 12 months, respectively (p<0.001). There were 7 primary covered stent occlusions (6.5% of 107 stented lesions: 3 not treated, 2 bypassed, 2 dilated or stented) and 5 (4.7%) recurrent in-stent occlusions (1 bypassed, 2 dilated, 2 untreated) during the 1-year follow-up. Primary patency rates were 92% at 6 months and 89.8% at 12 months for the entire cohort. Secondary patency rates were 98% and 95.6%, respectively. No statistically significant differences were observed in the primary patency rates for the SFAs (89.3% at both 6 and 12 months) versus the iliac arteries (94.3% at 6 months and 90.7% at 12 months).. Primary implantation of PTFE-covered nitinol stents in the iliac and superficial femoral arteries is technically feasible, safe, and effective, with excellent 1-year patency.

Topics: Aged; Alloys; Angioplasty, Balloon; Arterial Occlusive Diseases; Feasibility Studies; Female; Femoral Artery; Follow-Up Studies; Humans; Iliac Artery; Male; Middle Aged; Polytetrafluoroethylene; Prospective Studies; Severity of Illness Index; Stents; Time Factors; Treatment Outcome; Vascular Patency

The Cordis Randomized Iliac Stent Project-US (CRISP-US) trial evaluated, with an equivalence design, the performance of the shape memory alloy recoverable technology (SMART) nitinol self-expanding stent and the stainless steel Wallstent for treating iliac artery disease after suboptimal percutaneous transluminal angioplasty (PTA).. This multicenter, prospective, randomized trial comprised 203 patients with chronic limb ischemia who received either the SMART stent (n = 102) or the Wallstent (n = 101) after suboptimal PTA. The primary equivalence end point was a composite of 9-month restenosis, 30-day death, and 9-month target vessel revascularization. Functional, clinical, and hemodynamic assessments were made at hospital discharge and at 1, 6, 9, and 12 months.. The 9-month composite end point rate was equivalent for the SMART stent and Wallstent (6.9% vs 5.9%), with low rates of restenosis (3.5% vs 2.7%), death (2.0% vs 0.0%), and revascularization (2.0% vs 4.0%) in the two groups. Primary patency at 12 months was 94.7% and 91.1% with the SMART stent and Wallstent, respectively. Functional and hemodynamic improvement was also comparable between the groups. The acute procedural success rate was higher in the SMART stent group (98.2% vs 87.5%; P =.002). The frequency of major adverse events was similar at 1 year (4.9% vs 5.9%).. The performance of the SMART stent was equivalent to that of the Wallstent for treating iliac artery stenosis. The design characteristics of the SMART stent may contribute to greater procedural success and more accurate stent deployment.

Topics: Aged; Alloys; Angiography; Angioplasty; Arterial Occlusive Diseases; Female; Humans; Iliac Artery; Male; Safety; Stents

To evaluate the effectiveness, safety, and short-term patency rates of a self-expandable nitinol stent (JostentSelfX; Abbott Laboratories, Chicago, IL) for treatment of iliac artery stenoses.. In a prospective study, 34 chronic iliac artery stenoses were primarily treated in 27 patients (mean age, 61.7 years +/- 9.4) by placement of a JostentSelfX. Handling and visibility of the stent was scored on a 4-point scale. Before stent placement, within 3 days after stent placement and at 6 months follow-up, the clinical history, clinical stage according to the Rutherford classification, and the ankle-brachial index (ABI) were assessed. Intra-arterial digital subtraction angiography including measurement of the mean pressure gradient was performed at the time of stent placement and at 6 months follow-up or in case of recurrence of symptoms. The Wilcoxon signed rank test and Kaplan-Meier method were applied for statistical analysis.. The immediate technical success rate was 94%. The clinical success rate immediately after the procedure was 96% and 85% at 6 months follow-up. Stent placement significantly decreased the severity of stenoses as well as the mean pressure gradients and significantly increased the ABI. Handling of the stent was judged good. No misplacement occurred. Foreshortening during deployment was negligible and no stent migration was seen. However, visibility of the stent during fluoroscopy was ranked as moderate to bad. Follow-up at 6 months revealed the cumulative angiographic primary patency rate (<50% restenosis and <10 mm Hg mean pressure gradient) to be 0.96.. The evaluated self-expandable nitinol stent is an effective tool in treating iliac artery stenoses. Apart from poor visibility, handling was good. The angiographic patency rate is comparable with data reported in other stent trials.

Topics: Alloys; Angiography, Digital Subtraction; Angioplasty, Balloon; Arterial Occlusive Diseases; Equipment Design; Female; Follow-Up Studies; Humans; Iliac Artery; Male; Middle Aged; Prospective Studies; Severity of Illness Index; Statistics, Nonparametric; Stents; Treatment Outcome; Vascular Patency

We tested the value of hemobahn-endoprosthesis in a prospective, nonrandomized, clinical trial in PAD-patients with femoral artery occlusive disease. During 4 years we placed in 52 patients (55 extremities) a total of 78 hemobahn-endoprostheses for treatment of stenoses (15%) or occlusions (85%) of femoral artery. The average length of the treated lesions was 11.6 cm, the mean length of the hemobahn-endoprosthesis was 15.9 cm, the average device diameter 6.1 mm. In 45% of the patients we used cross-over and in 55% ipsilateral antegrade technique. Fontaine's clinical stages were II b (89%), III (2%) and IV (9%); there were 15 diabetics. The average period of follow-up was 33 months (1-52 months). The primary/secondary patency rates after the first year (n = 50) were 64% vs. 78%, after 2 years (n = 46) 61% vs. 76%, after 3 years (n = 32) 53% vs. 66% and after 4 years (n = 14) 29% vs. 50%. After the first experiences in 1998 with 10 stent-occlusions in 14 treated extremities, indications were checked and thereafter hemobahn was only used in "ideal indications" as segments with a length of > or = 1 cm proximal and distal without any obstruction, no lesions in the popliteal artery, at least one open lower leg vessel and no severe calcifications. The primary/secondary patency rates were significantly better after exclusion of nonideal patients treated during the first year: Thus, primary/secondary patency rates were 76 % vs. 90% after first year (n = 32), 74 % vs. 89% after second year (n = 38) and 71% vs. 83% after third year (n = 24); after 4 years of 8 treated arteries 4 were primary and 7 were secondary open. Hemobahn-endoprostheses are suitable for treatment of long femoral artery occlusions. The medium patency rate in "ideal indications" is higher than that obtained by angioplasty with or without uncovered stents.

Topics: Aged; Alloys; Angioplasty, Balloon; Arterial Occlusive Diseases; Blood Vessel Prosthesis Implantation; Constriction, Pathologic; Female; Femoral Artery; Follow-Up Studies; Humans; Male; Middle Aged; Prospective Studies; Stents; Time Factors; Vascular Patency

Stent implantation for obstructive femoropopliteal artery disease has been associated with poor long-term outcomes. This study evaluated the effectiveness of shape memory alloy recoverable technology (SMART) nitinol self-expanding stents coated with a polymer impregnated with sirolimus (rapamycin) versus uncoated SMART stents in superficial femoral artery obstructions.. Thirty-six patients were recruited for this double-blind, randomized, prospective trial. All patients had chronic limb ischemia and femoral artery occlusions (57%) or stenoses (average lesion length, 85+/-57 mm). Patients were eligible for randomization after successful guidewire passage across the lesion. Eighteen patients received sirolimus-eluting SMART stents and 18 patients received uncoated SMART stents. The primary end point of the study was the in-stent mean percent diameter stenosis, as measured by quantitative angiography at 6 months. The in-stent mean percent diameter stenosis was 22.6% in the sirolimus-eluting stent group versus 30.9% in the uncoated stent group (P=0.294). The in-stent mean lumen diameter was significantly larger in the sirolimus-eluting stent group (4.95 mm versus 4.31 mm in the uncoated stent group; P=0.047). No serious adverse events (death or prolonged hospitalization) were reported.. The use of sirolimus-eluting SMART stents for superficial femoral artery occlusion is feasible, with a trend toward reducing late loss compared with uncoated stents. The coated stent also proved to be safe and was not associated with any serious adverse events.

Topics: Aged; Alloys; Arterial Occlusive Diseases; Double-Blind Method; Female; Femoral Artery; Graft Occlusion, Vascular; Humans; Immunosuppressive Agents; Male; Radiography; Sirolimus; Stents; Treatment Outcome

Because first-generation stent-grafts did not meet initial expectations, a recently designed nitinol-expanded polytetrafluoroethylene (ePTFE) stent-graft was tested for treatment of abdominal aortic aneurysms (AAAs) in a prospective clinical study. The primary study endpoints were technical success and safety.. A nitinol-ePTFE self-expandable stent-graft (Excluder) was used to treat 72 patients with AAAs. The median follow-up period was 21.5 months +/- 13 (range, 1-46 mo).. Primary technical success in accurate placement of the device was achieved in 70 of 72 patients (97%). Complete exclusion of the aneurysm from arterial flow was achieved in 57 of 72 patients (79.2%). Three type I leaks were observed during implantation and were immediately corrected with a proximal cuff prosthesis in two patients. Fourteen of 72 patients (19.4%) had a type II leak. Major complications were observed in three patients (4.1%), including one death in the early postinterventional period (one of 72, 1.4%). At 3 months, aneurysms were excluded in 70 of 71 patients (98.6%), and at 12 months, aneurysms were occluded in 29 of 30 patients (96.7%). The maximum diameter of the aneurysm decreased from 55 mm +/- 11 (median +/- SD) before intervention to 53 mm +/- 13 at 6 and 12 months. None of the patients showed aneurysm growth.. This newly designed stent-graft proved to be effective and safe for treatment of AAAs.

Topics: Aged; Aged, 80 and over; Alloys; Aortic Aneurysm, Abdominal; Arterial Occlusive Diseases; Blood Vessel Prosthesis Implantation; C-Reactive Protein; Coated Materials, Biocompatible; Combined Modality Therapy; Endpoint Determination; Equipment Safety; Female; Follow-Up Studies; Humans; Iliac Artery; Inflammation; Length of Stay; Leukocyte Count; Male; Middle Aged; Polytetrafluoroethylene; Postoperative Complications; Prospective Studies; Prosthesis Design; Radiography, Interventional; Stents; Survival Analysis; Time Factors; Treatment Outcome; Vascular Resistance

To evaluate the safety and efficacy of an endoluminal prosthesis for treatment of peripheral arterial occlusive disease (PAOD).. A self-expanding endoprosthesis with an expanded polytetrafluoroethylene tube inside a nitinol support structure was implanted in 127 patients with symptomatic PAOD in the iliac (61 limbs) and femoral arteries (80 limbs). Clinical category status, ankle-brachial index, and color duplex flow imaging results were recorded before treatment, at discharge, and at 1, 3, 6, and 12 months after treatment. Aspirin was administered throughout the study, and heparin was administered during and for 2 days after the procedure.. Endoprosthesis deployment was technically successful in all patients. Complications occurred in 24 of 141 procedures and included three major complications. Early thrombosis (within 30 days) occurred in one iliac and three femoral arteries. Late restenosis or reocclusion was observed in five iliac and 14 femoral arteries within the 1st year. Primary patency rates in iliac arteries were 98% +/- 3% (standard error) and 91% +/- 4%, respectively, at 6 and 12 months after treatment. Primary patency rates in femoral arteries were 90% +/- 3% and 79% +/- 5%, respectively, at 6 and 12 months. Secondary patency rates were 95% and 93% for iliac and femoral arteries, respectively, at 12 months after treatment.. The device used in this study can be implanted without additional risks to the patient and provided encouraging patency rates up to 1 year.

Topics: Adult; Aged; Aged, 80 and over; Alloys; Angiography, Digital Subtraction; Arterial Occlusive Diseases; Equipment Design; Evaluation Studies as Topic; Female; Femoral Artery; Humans; Iliac Artery; Life Tables; Male; Middle Aged; Peripheral Vascular Diseases; Polytetrafluoroethylene; Prospective Studies; Risk Factors; Stents; Treatment Outcome; 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

Introduction-patients: Takayasu arteritis may involve various parts of the aorta and its major branches. It leads to occlusive or aneurysmal disease of the vessel. It can be treated either with surgery or percutaneous intervention. We report a successful endovascular treatment of stenosis of the descending thoracic and abdominal aorta in a 19-year-old female. Methods-results-conclusions: Self-expandable nitinol stent was deployed and adequate opening of the aorta was obtained in this patient. Long-term durability of endovascular approach is a matter of debate. We also reviewed the sufficiency of endovascular treatment versus surgery.

Topics: Alloys; Aorta, Abdominal; Aorta, Thoracic; Aortography; Arterial Occlusive Diseases; Endovascular Procedures; Female; Humans; Prosthesis Design; Self Expandable Metallic Stents; Syndrome; Takayasu Arteritis; Tomography, X-Ray Computed; Young Adult

Topics: Adult; Alloys; Arterial Occlusive Diseases; Brachiocephalic Trunk; Cardiovascular Abnormalities; Constriction, Pathologic; Endovascular Procedures; Female; Humans; Ischemia; Osteotomy; Risk Factors; Self Expandable Metallic Stents; Subclavian Artery; Thoracic Outlet Syndrome; Treatment Outcome

Objective This study aimed to evaluate the safety and the efficacy of primary stenting to treat Trans-Atlantic Inter-Society Consensus II (TASC) D femoropopliteal lesions. Background Advances in wire, balloon and stent design have been reported to improve the durability of stenting of longer femoropopliteal lesions. Methods A total of 57 limbs of 53 patients with Rutherford stage 3 to 6 due to TASC D femoropopliteal lesions were treated with a self-expanding nitinol stent in a prospective, single-centre, observational study. End points of interest included primary and secondary patency, target lesion revascularization, in-stent restenosis, major adverse cardiovascular events, Rutherford class improvement and change in walking capacity at 1 year. Results A total of 53 patients (57 lesions) were treated with a self-expanding nitinol stent and final procedural success was 91.2%. The median length of the treated segment was 330 ± 96 mm. The median stented segment was 366 ± 71 mm and the mean number of the stents was 2.1 ± 0.9. At 1 year, primary and secondary patency rates were 63.9% and 82.1%, respectively. Major adverse cardiovascular events occurred in 11 patients (22.9%), and[[strike_start]] [[strike_end]]significant benefits were observed in Rutherford class and walking distance (both P < 0.001). Conclusions Primary implantation of self-expanding nitinol stents for the treatment of TASC D femoropopliteal lesions appears to be safe and effective, especially in patients who have multiple co-morbidities and a high risk for surgical bypass. The risk of restenosis was higher when long stenting was extended to the popliteal artery.

Topics: Aged; Alloys; Angioplasty; Arterial Occlusive Diseases; Chronic Disease; Female; Femoral Artery; Follow-Up Studies; Humans; Male; Popliteal Artery; Prospective Studies; Prosthesis Design; Self Expandable Metallic Stents; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Duplex

Lower extremity ischemia following deployment of a vascular closure device for access site closure after a transfemoral endovascular procedure rarely occurs. A 68-year-old woman diagnosed with subarachnoid hemorrhage due to a ruptured anterior communicating aneurysm was treated by endovascular coil embolization. The StarClose SE device was deployed for right femoral arteriotomy closure. After 2 days, critical ischemia occurred on her right lower leg due to total occlusion of the popliteo-tibial artery. Emergent surgical embolectomy was performed and the nitinol clip of the StarClose device was captured in the lumen of the tibioperoneal trunk. Although StarClose is an extravascular closure system, intravascular deployment, distal migration, and resultant critical limb ischemia can occur.

Topics: Aged; Alloys; Arterial Occlusive Diseases; Embolectomy; Embolization, Therapeutic; Female; Femoral Artery; Foreign-Body Migration; Hemostatic Techniques; Humans; Ischemia; Lower Extremity; Popliteal Artery; Surgical Instruments; Tibial Arteries; Treatment Outcome

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

The purpose of this study was to characterize the hemodynamics of peripheral artery stent grafts to guide intelligent stent redesign.. Two surgically explanted porcine arteries were mounted in an ex vivo system with subsequent deployment of an Xpert self-expanding nitinol stent or Viabahn stent graft. The arteries were casted with radiopaque resin, and the cast then scanned using micro-computed tomography at 8μm isotropic voxel resolution. The arterial lumen was segmented and a computational mesh grid surface generated. Computational fluid dynamics (CFD) analysis was subsequently performed using COMSOL Multiphysics 5.1.. CFD analysis demonstrated low endothelial shear stress (ESS) involving 9.4 and 63.6% surface area of the central stent graft and bare metal stent, respectively. Recirculation zones were identified adjacent to the bare metal stent struts, while none were identified in the central stent graft. However, the stent graft demonstrated malapposition of the proximal stent graft edge with low velocity flow between the PTFE lining and arterial wall, which was associated with longitudinally and radially oriented recirculation zones and low ESS.. Computational hemodynamic analysis demonstrates that peripheral artery stent grafts have a superior central hemodynamic profile compared to bare metal stents. Stents grafts, however, suffer from malapposition at the proximal stent edge which is likely a major contributor to edge stenosis.

Topics: Alloys; Animals; Arterial Occlusive Diseases; Coated Materials, Biocompatible; Hemodynamics; Models, Animal; Polytetrafluoroethylene; Self Expandable Metallic Stents; Stents; Swine; X-Ray Microtomography

Although intravascular ultrasound (IVUS) predictors of stent patency for the coronary artery lesion have been established, little is known about IVUS predictors of stent patency for the aorto-iliac artery lesion. We analyzed 154 lesions of 122 patients who underwent stent implantation for iliac artery lesions. Quantitative and qualitative IVUS analyses were performed for pre- and post-procedural IVUS imaging in all lesions. Target lesion revascularization (TLR) was defined as clinically driven revascularization with >50 % angiographic stenosis of the target lesion. The mean follow-up period was 39 ± 16 months. TLRs were performed in 13 lesions (8.4 %). Post-procedural minimum stent area (MSA) was significantly smaller in the TLR group compared to the no-TLR group (16.0 ± 5.8 vs. 25.6 ± 8.5 mm(2), p < 0.001). Stent edge dissection was frequently observed in the TLR group compared to the no-TLR group (53.8 vs. 24.1 %, p = 0.04). Multivariate analysis revealed that post-procedural MSA (OR = 0.76, p < 0.01) and stent edge dissection (OR = 10.4, p < 0.01) were independent IVUS predictors of TLR. Receiver-operating characteristic analysis identified post-procedural MSA <17.8 mm(2) as the optimal cut-point for the prediction of TLR (AUC = 0.846). Post-procedural MSA and stent edge dissection could predict long-term stent patency in the iliac artery lesion. Our results propose that adequate stent enlargement without edge dissection might be important to reduce TLR in the iliac artery lesion.

Topics: Aged; Alloys; Angiography; Arterial Occlusive Diseases; Endovascular Procedures; Female; Follow-Up Studies; Humans; Iliac Artery; Male; Prospective Studies; Reproducibility of Results; Self Expandable Metallic Stents; Time Factors; Ultrasonography, Interventional; Vascular Patency

Mechanical tests assessing Nitinol stents used for the superficial femoral artery (SFA) are designed without taking into account their deployment environments. The objectives of this study were (1) to create normal and pathologic femoral artery models, (2) to run mechanical tests reproducing the stresses of the SFA, and (3) to study and compare Nitinol stents in those conditions.. Femoral artery models with identical mechanical properties to the SFA were created using the 3-dimensional printing technology. Those models were designed with and without an asymmetric focal 50% stenosis. Three mechanical tests (bending-compression, bending-compression-torsion, and multiple bending tests) were created and 1 flexible stent was tested, of 6 and 7-mm diameter. Three samples of the stent, LifeStent (Bard(®)), were deployed and tested in the models. Stents alone were evaluated in the same conditions. The analysis focused on the comparison of rheologic curves, level of kink, and the energy deployed for each stent to kink.. In the 3 tests, all stents deployed in the models presented a kink during their evaluation. When tested alone, during the compression-bending and bending-compression-torsion tests, no plicature was observed. During the multiple bending test, the energy deployed to plicature for the stent tested alone was of 1.4 ± 0.10 and 2.84 ± 0.1 J compared with 9.7 ± 0.6 and 8.25 ± 0.6 J when deployed in the model for the Lifestent 6 × 80 and 7 × 80 mm, respectively. For all of these 3 tests, 6-mm diameter stents exhibited a level of kink and energy of kink higher than 7 mm stents. The behavior of the stents changed in the stenosed model whatever diameter is taken into account. Analysis of the rheologic curves showed a decrease in the inflection of the curve related to the plication. In the bending-compression test, the presence of a stenosis lead to an early plication of the model, with less deployed kinking energy whereas in the bending, compression, and torsion test, this earliness was absent.. This study permitted the creation of a mechanical test platform evaluating Nitinol stents in bending situations. It tends to confirm the mechanical deleterious effect of excessive oversizing. This study confirms the necessity to evaluate Nitinol stents in their deployment environments.

Topics: Alloys; Arterial Occlusive Diseases; Compressive Strength; Constriction, Pathologic; Elastic Modulus; Endovascular Procedures; Equipment Failure Analysis; Femoral Artery; Hemodynamics; Humans; Materials Testing; Models, Anatomic; Models, Statistical; Printing, Three-Dimensional; Prosthesis Design; Prosthesis Failure; Regional Blood Flow; Rheology; Stents; Stress, Mechanical; Tensile Strength; Torsion, Mechanical

The mechanical properties of the self-expanding nitinol stents (SENS) and chronic biological stimulation on the wall from the SENS have not been fully investigated. This study evaluated the mechanical vascular response to SENS implantation in superficial femoral artery (SFA) lesions using serial volumetric intravascular ultrasound (IVUS). Twenty-five symptomatic patients due to de novo SFA lesions scheduled for SENS placement were prospectively enrolled. Serial IVUS studies were performed immediately after crossing with a guidewire, immediately after the procedure, and at a 8-month follow-up. Serial IVUS volumetric analysis was conducted after stent deployment and at follow-up. Mean stent, lumen and neointimal areas were calculated as the volume divided by the stent length, and the calcium arc was measured. At follow-up, SENS had increased 40.6 % in overall volume. The chronic stent expansion tended to be larger, and the mean neointimal area at the 8-month follow-up was significantly larger in less calcified lesions compared to heavily calcified lesions. As a result, the mean late lumen area loss was significantly larger in lesions with calcium arcs of 0° and in the first and second quadrants than in those with calcium arcs in the third and fourth quadrants (2.8 ± 7.2, 1.3 ± 5.6, 0.6 ± 5.9, 1.2 ± 5.4, -0.8 ± 5.2 mm(2), respectively; p < 0.001). SENSs continued to enlarge with intimal proliferation over 8 months in all lesions. Although arterial calcium affected the degree of chronic stent expansion during the follow-up period, neointimal proliferation was smaller in heavily calcified lesion compared to less calcified lesion following SENS implantation.

Topics: Aged; Aged, 80 and over; Alloys; Arterial Occlusive Diseases; Coronary Vessels; Endovascular Procedures; Female; Femoral Artery; Follow-Up Studies; Humans; Male; Prospective Studies; Self Expandable Metallic Stents; Ultrasonography, Interventional; Vascular Resistance

To evaluate the long-term outcomes of self-expandable nitinol stent implantation with intraluminal angioplasty for chronic total occlusion (CTO) in the superficial femoral artery (SFA) of patients with TransAtlantic Inter-Society Consensus (TASC) D lesions.. From 2004 to 2011, self-expandable nitinol stent implantation in SFA was performed successfully in 72 consecutive limbs of 68 patients with TASC D lesions. These patients were assessed for an average of 38.8 ± 25.6 months. The procedure was performed using a 0.014" or 0.018" guidewire and intraluminal angioplasty.. Patients with hemodialysis constituted 20.6% of cases. The mean occlusion length was 244.6 ± 34.1 mm. A bidirectional approach was performed in 69.4% of cases. Primary patency rates were 77.9%, 71.9%, 67.2%, and 51.5% at 1 year, 2 years, 3 years, and 5 years, respectively. Secondary patency rates were 88.6%, 78.7%, 71.1%, and 56.0% at 1 year, 2 years, 3 years, and 5 years, respectively. Cox regression multivariate analysis for hemodialysis pertaining to loss of primary and secondary patency resulted in hazard ratio = 2.555 (95% confidence interval, 1.108-5.891; P=.03) for loss of primary patency and hazard ratio = 3.615 (95% confidence interval, 1.380-9.471; P=.01) for loss of secondary patency.. Long-term patency of self-expandable nitinol intraluminal stent implantation with intraluminal angioplasty to treat CTO (TASC D) in SFA is promising. Hemodialysis was the only independent predictor for loss of primary and secondary patency.

Topics: Aged; Alloys; Angiography; Angioplasty, Balloon; Arterial Occlusive Diseases; Chronic Disease; Consensus; Endovascular Procedures; Female; Femoral Artery; Follow-Up Studies; Humans; Leg; Male; Prosthesis Design; Retrospective Studies; Self Expandable Metallic Stents; Time Factors

Critical limb ischemia may be the consequence of chronic occlusion of an aneurysm of popliteal artery. Endovascular repairs have the potential to be less invasive than open surgery and to allow the treatment, during the same procedure, of occlusive infrapopliteal diseases achieving a better distal outflow. Eleven patients with occluded popliteal artery aneurysm (PAA) underwent an endovascular repair of PAA using a new technique, by positioning of a Viabahn graft inside a bare nitinol stent, deployed at the level of aneurysm with the intent to avoid distal embolization and to assure an external scaffold for the Viabahn graft. Immediate success rate was 100%. A peroneal artery embolization occurred in 1 patient (9%) and was successfully treated by stent implantation. Four (36.4%) patients needed a below-the-knee revascularization to achieve at least 1 vessel line to the foot. Mean postoperative hospital stay was 2.6 days. At 24-month follow-up, primary patency, target lesion revascularization, and major amputation rates were 82%, 9%, and 0%, respectively. All patients are still alive at last follow-up visit. The endovascular repair with the combined use of a bare metal stent and Viabahn graft resulted in a low incidence of distal embolization and major amputation rate, with an excellent 24-month patency rate, and may offer a safe alternative to open surgery for the treatment of occluded PAAs.

Topics: Aged; Aged, 80 and over; Alloys; Amputation, Surgical; Arterial Occlusive Diseases; Blood Vessel Prosthesis; Blood Vessel Prosthesis Implantation; Chronic Disease; Constriction, Pathologic; Endovascular Procedures; Female; Humans; Limb Salvage; Male; Popliteal Artery; Prosthesis Design; Risk Factors; Stents; Time Factors; Treatment Outcome; Vascular Patency

Topics: Alloys; Aorta, Abdominal; Arterial Occlusive Diseases; Blood Vessel Prosthesis Implantation; Endovascular Procedures; Humans; Iliac Artery; Metals; Peripheral Vascular Diseases; Stents

Although patients receiving hemodialysis (HD+) have significantly different backgrounds, including a history of progressive atherosclerotic disease, compared with those not receiving hemodialysis (HD-), there are no studies evaluating the risks for loss of primary patency (PP) and need for target lesion revascularization (TLR) in HD+ patients following bare self-expandable nitinol stent (BSNS) implantation to femoropopliteal (FP) artery occlusive lesions, after adjusting for differences using propensity score (PS) analysis in observed characteristics between groups.. We studied 531 limbs of 432 Japanese patients (HD+, n=107; HD-, n=325) who received BSNS implantation to FP lesions between 2004 and 2014. Patients were followed-up for an average of 44.3±33.6months. We compared the long-term results between HD+ and HD- patients using the Cox-proportional hazard model with adjustment for inverse probability treatment weight (IPTW) of PS, which was calculated for covariates with HD as a dependent variable.. PP rate in HD+ vs. HD- patients at 9years after the procedure was 19.1% vs. 47.9%, with a freedom from TLR rate of 47.6% vs. 62.9%, respectively. Adjusted HRs in HD+ patients with 95% confidence intervals (CIs) were as follows: loss of PP: HR 1.64, 95% CI 1.052-2.557, P=0.03; TLR: HR 1.862, 95% CI 1.104-3.139, P=0.02.. The present study suggests that HD+ patients have an increased risk for loss of PP and need for TLR after BSNS implantation to FP lesions.

Topics: Aged; Aged, 80 and over; Alloys; Arterial Occlusive Diseases; Female; Femoral Artery; Follow-Up Studies; Humans; Male; Metals; Middle Aged; Popliteal Artery; Renal Dialysis; Retrospective Studies; Risk Factors; Self Expandable Metallic Stents; Time Factors; Vascular Patency

Endovascular therapy for aortoiliac (AI) lesions using stents is widely accepted. However, the long-term outcome of 2 different types of nitinol stents for AI lesions is unknown. The aim of this study was to examine the long-term outcome of the SMART and Luminexx nitinol stents for the treatment of de novo AI lesions.. This study was a multicenter retrospective analysis of a prospectively maintained database. The study enrolled consecutive patients undergoing primary stenting for de novo AI artery stenosis between January 2005 and December 2009. A total of 1503 lesions in 1229 patients treated with SMART or Luminexx primary stenting were enrolled. The primary end point was primary patency, secondary end points were the primary assisted patency, secondary patency, and major adverse limb events (MALEs), which included major amputation and major reintervention. To minimize the differences between the groups, a propensity score matching analysis was performed, and 284 lesions per group were analyzed to identify outcomes.. After the propensity score matching analysis, the lesion length was 60 ± 37 and 57 ± 31 mm (P = .275), and the reference vessel diameter was 8.2 ± 1.5 and 8.3 ± 1.5 mm (P = .482) in the SMART and Luminexx groups, respectively. The primary patency at 3 years was not significantly different between the groups (83.5% vs 82.2%, P = .842, respectively). The assisted primary patency and secondary patency rates were also not significantly different (91.7% vs 93.2%, P = .340, 99.2% vs 98.8%, P = .922). In addition, the MALE rate was not significantly different between the groups (98.3% vs 97.3%, P = .821).. The current data suggest that the use of nitinol stents for the AI artery provided good long-term patency and freedom from MALE for 3 years of follow-up, regardless of whether SMART or Luminexx stents were used.

Topics: Aged; Aged, 80 and over; Alloys; Amputation, Surgical; Aortic Diseases; Arterial Occlusive Diseases; Constriction, Pathologic; Databases, Factual; Endovascular Procedures; Female; Humans; Iliac Artery; Japan; Kaplan-Meier Estimate; Limb Salvage; Logistic Models; Male; Middle Aged; Propensity Score; Prosthesis Design; Recurrence; Retrospective Studies; Risk Factors; Stents; Time Factors; Treatment Outcome; Vascular Patency

To report the immediate and mid-term clinical and anatomical outcomes of a novel, hybrid, heparin-bonded, nitinol ring stent (TIGRIS; Gore Medical) when used for the treatment of lesions located in the popliteal artery.. This was a prospective single-centre registry. Patients eligible for inclusion were individuals suffering from symptomatic popliteal arterial occlusive disease (Rutherford-Becker stage 3-6; P1-P3 segments) and treated with placement of the TIGRIS stent(s). Patients were prospectively scheduled for clinical review and duplex ultrasound follow-up after 6 and 12 months. Outcome measures included immediate technical success, primary vessel patency, in-stent binary restenosis (evaluable by Duplex at 50 % threshold; PSVR > 2.0), freedom from target lesion revascularization (TLR) and amputation-free survival (AFS) estimated by Kaplan-Meier (K-M) survival analysis. Cox proportional-hazards regression analysis was also performed to adjust for confounders and search for independent predictors of outcomes.. From August 2012 to March 2014, a total of 54 popliteal TIGRIS stents were implanted in 50 limbs of 48 patients (27 men and 21 women; mean age 76.0 ± 1.7 years). Median Rutherford-Becker stage was five at baseline and 37/50 (74.0%) were chronic total occlusions. Technical success was achieved in all cases (100%). Stented lesion length was 114.2 ± 36.9 mm (range 6-20 cm). Median follow-up was 11.8 ± 0.8 months. After 12 months, primary patency of the TIGRIS stent was 69.5 ± 10.2% with an 86.1 ± 5.9% freedom from TLR and 87 ± 5.0% AFS (K-M estimates).. The TIGRIS hybrid heparin-bonded nitinol ring stent is a safe and effective endovascular option for complex occlusive disease of the popliteal artery.

Topics: Aged; Alloys; Anticoagulants; Arterial Occlusive Diseases; Female; Follow-Up Studies; Heparin; Humans; Kaplan-Meier Estimate; Male; Popliteal Artery; Proportional Hazards Models; Prospective Studies; Prosthesis Design; Radiography, Interventional; Stents; Treatment Outcome; Vascular Patency

Advances in endovascular technology led to an alternative treatment option for TASC II D (TransAtlantic Inter-Society Consensus II class D) lesions. This study was aimed to evaluate the outcomes of endovascular treatment for TASC II D femoropopliteal lesions.. Endovascular intervention with bare nitinol stent implantation was performed on 58 limbs (53 patients) with TASC II D femoropopliteal lesions from January 2011 to March 2013. Kaplan-Meier curves of primary patency, assisted patency and second patency were performed. Predictive factors of re-stenosis/occlusion were evaluated by univariate methods.. Total 53 patients with mean age of 74.2 ± 8.2 (range, 58.0-91.0 years) and mean lesion length of 314.8 ± 64.3 mm (188.2-400.4 mm) were enrolled. The mean follow-up time was 12.2 ± 6.1 months (5-38 months). Revascularization was successfully on 95% lesions by bare nitinol stent implantation. Primary patency rates at 1, 2 and 3 years were 63%, 12% and 12%, respectively. Assisted primary patency rates at 1, 2 and 3 years were 77%, 31% and 31%, respectively. Secondary patency rates at 1, 2 and 3 years were 96%, 63% and 63%. During one-year follow-up, no major amputation was occurred. Univariate analysis revealed that number of run-off vessels was a potential predictor of re-stenosis/occlusion.. Endovascular treatment of TASC II D femoropopliteal artery occlusion has a high technical success rate with acceptable one-year patency rate. The long-term outcomes are poor, but endovascular intervention could be a good alternative for patients unsuitable for surgical bypass.

Topics: Aged; Aged, 80 and over; Alloys; Arterial Occlusive Diseases; Endovascular Procedures; Female; Femoral Artery; Humans; Male; Middle Aged; Recurrence; Retrospective Studies; Risk Factors; Stents; Treatment Outcome; 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 report a novel indication for the use of chimney grafts to preserve flow to the inferior mesenteric artery (IMA) in patients undergoing endovascular aneurysm repair (EVAR) for aortobi-iliac aneurysms with coexistent bilateral occlusion of the internal iliac arteries (IIA).. Via a cutdown over the left axillary artery, a 5-F vertebral catheter was delivered over a conventional 0.035-inch hydrophilic guidewire to selectively catheterize the IMA via a 7-F shuttle sheath, which was then advanced at least 2 cm into the target vessel. The first chimney graft was advanced into the sheath, and a standard EVAR procedure followed. The chimney graft was deployed at least 2 cm in the IMA; a second chimney graft was advanced and deployed with at least 2 cm overlapping with the first chimney stent parallel and outside of the main abdominal endograft and below the lowest renal artery. The chimney grafts were lined with additional bare nitinol stents. The technique is demonstrated in two male patients who suffered from symptomatic aortobi-iliac aneurysm with patent IMAs and bilateral IIA occlusion. The procedure was completed successfully in both cases without bowel ischemia. At 12 and 6 months, respectively, the chimney grafts remained patent without endoleak. The patients are asymptomatic.. The IMA chimney endovascular technique can be considered in EVAR cases with coexistent bilateral IIA occlusion to minimize the risk for bowel ischemia.

Topics: Aged; Alloys; Aortic Aneurysm, Abdominal; Aortography; Arterial Occlusive Diseases; Blood Vessel Prosthesis; Blood Vessel Prosthesis Implantation; Constriction, Pathologic; Endovascular Procedures; Humans; Iliac Artery; Male; Mesenteric Artery, Inferior; Prosthesis Design; Regional Blood Flow; Stents; Time Factors; Treatment Outcome; Vascular Patency

Primary patency (PP) in trials assessing superficial femoral artery (SFA) stenting is defined as a combination of vessel patency assessed by duplex ultrasound (DUS) at the 12-month follow-up exam and freedom from revascularization of the index vessel through 12 months of follow-up. Loss of PP is thus more likely to be identified during the mandated DUS assessment. Moreover, DUS is performed within a prespecified allowed window of time for the visit that exceeds 12 months (typically by 30 days). Therefore, the time frame for detecting patency with DUS exceeds the time frame in which revascularization is captured. Survival analyses are often applied to present estimates of freedom from loss of PP, but there are no clear guidelines as to the correct method for presenting these analyses in reports from clinical trials. We aimed to analyze the implications of applying different methods in assessing freedom from loss of PP in studies assessing stenting for diseased SFA.. Data were simulated based on existing available results from SFA bare-metal nitinol stent trials published between 2009 and 2013 and summarized in a previous analysis (STROLL, SUPERB, RESILIENT, DURABILITY I, DURABILTY II, COMPLETE SFA). Six different approaches to Kaplan Meier (KM) analyses were applied based on entry criteria into and time frame of the KM model.. Six KM estimates of PP were generated for each of the 10,000 simulated datasets. The average exact PP rate was 70.6%, while the average estimated KM rates using the six different methods ranged between 68.0% and 81.9%.. KM estimates of PP vary substantially according to the methods employed. These may lead to misrepresentation of results from clinical trials. The development of a unified approach is advocated.

Topics: Alloys; Arterial Occlusive Diseases; Bias; Clinical Trials as Topic; Equipment Failure; Femoral Artery; Follow-Up Studies; Humans; Postoperative Complications; Recurrence; Stents; Survival Analysis; Treatment Failure; Vascular Patency

To investigate the 5-year patency rates and predictors of restenosis after self-expanding nitinol stent implantation for chronic total occlusion (CTO) in superficial femoral and proximal popliteal artery (SFPA) lesions.. Outcomes and long-term patency rates after self-expanding nitinol stent for CTO in the SFPA lesions have not been clarified.. From January 2004 to December 2009, 861 serial arteriosclerosis obliterans patients, 1,017 limbs, underwent endovascular therapy with implantation of a self-expanding nitinol stent for SFPA lesions at four institutions in Japan. Of the cohort, 352 patients, 383 limbs, had self-expanding nitinol stents implanted for CTOs in the SFPA and were followed for 5 years. We retrospectively investigated patency rate and multivariate predictors associated with restenosis.. Mean age was 72 ± 9 years and 31% were female patients. In total, 58% of the patients had diabetes mellitus and 25% were patients with critical limb ischemia. Occluded length was 194 ± 89 mm, mean total stent length was 198 ± 7 mm, and mean stent diameter was 7.1 ± 0.9 mm. Five-year primary and secondary patency rates were 51.8 and 79.5%, respectively, and the rates of freedom from bypass surgery, major or minor amputation, and all-cause death were 96.1, 96.2, and 78.4%, respectively. Female gender (odds ratio, 1.95; P = 0.0051) and mean stent diameter (odds ratio, 0.77; P = 0.0324) were factors strongly associated with restenosis.. Women and patients requiring small stents failed to maintain primary patency when treated with self-expanding nitinol stents for CTO lesions in the SFPA. Although primary patency was low, the secondary patency rate was acceptable.

Topics: Aged; Aged, 80 and over; Alloys; Amputation, Surgical; Angioplasty, Balloon; Arterial Occlusive Diseases; Chronic Disease; Constriction, Pathologic; Female; Femoral Artery; Humans; Japan; Kaplan-Meier Estimate; Limb Salvage; Logistic Models; Male; Middle Aged; Multivariate Analysis; Odds Ratio; Popliteal Artery; Prosthesis Design; Recurrence; Retrospective Studies; Risk Factors; Sex Factors; Stents; Time Factors; Treatment Outcome; Vascular Patency

Topics: Alloys; Arterial Occlusive Diseases; Blood Vessel Prosthesis; Blood Vessel Prosthesis Implantation; Endovascular Procedures; Female; Femoral Artery; Humans; Male; Stents

Intraluminal femoropopliteal stenting enables favorable dilation and good immediate results; however, whether this contributes to long-term patency is unclear. We compared patency after femoropopliteal stenting for a long occlusion using either an intraluminal or subintimal approach.. Between January 2004 and December 2011, 902 endovascular procedures using either an intraluminal approach (651 procedures) or a subintimal approach (251 procedures) for long femoropopliteal occlusion were analyzed retrospectively. The outcomes of this study were periprocedural complication; primary, assisted-primary, and secondary patency; and overall survival.. The mean follow-up period of survivors was 29 ± 16 months. Between the intraluminal and subintimal approach, technical success (91% vs 90%; P = .71) and periprocedural complications (11% vs 13%; P = .34) were similar. However, procedure time was significantly longer for the intraluminal approach (126 ± 63 minutes vs 98 ± 49 minutes; P = .003). The improvement of ankle-brachial index was also similar. A quarter of cases started with the intraluminal approach were switched to a subintimal approach. There was no significant difference in primary, assisted-primary and secondary patency at 3 years between the two groups (55% vs 53%; P = .30; 65% vs 74%; P = .11; and 80% vs 85%; P = .37). The 3-year overall survival also did not differ significantly between groups (84% vs 86%; P = .55). After adjusting for baseline differences, the subintimal approach was found to be similar to the intraluminal approach for primary patency (hazard ratio, 1.21; 95% confidence interval, 0.94-1.56; adjusted P = .14).. Initial result and 3-year patency was similar in both approaches. Given the longer procedure time and high crossover rate, we suggest that a subintimal approach may be preferred in the treatment of long femoropopliteal occlusions with stenting.

Topics: Aged; Aged, 80 and over; Alloys; Arterial Occlusive Diseases; Endovascular Procedures; Female; Femoral Artery; Follow-Up Studies; Humans; Japan; Male; Popliteal Artery; Prosthesis Design; Retrospective Studies; Stents; Survival Rate; Time Factors; Treatment Outcome; Vascular Patency

A case of femoral artery obstruction following application of a StarClose type arterial puncture closing device (APCD) is presented. Ultrasonographic and angiographic imaging of this complication was obtained. The posterior wall of the vessel was accidentally caught in the anchoring element of the nitinol clip. This complication was successfully resolved by endovascular treatment and the implantation of a stent.

Topics: Alloys; Arterial Occlusive Diseases; Constriction, Pathologic; Equipment Design; Femoral Artery; Hemostatic Techniques; Humans; Male; Middle Aged; Punctures; Radiography; Stents; Treatment Outcome; Ultrasonography; Vascular Surgical Procedures

Uncoated self-expanding nitinol stents (NS) are commonly oversized in peripheral arteries. In current practice, 1-mm oversizing is recommended. Yet, oversizing of NS may be associated with increased restenosis. To provide further evidence, NS were implanted in porcine iliofemoral arteries with a stent-to-artery-ratio between 1.0 and 2.3. Besides conventional uncoated NS, a novel self-expanding NS with an antiproliferative titanium-nitride-oxide (TiNOX) coating was tested for safety and efficacy.. Ten uncoated NS and six TiNOX-coated NS (5-6 mm) were implanted randomly in the iliofemoral artery of six mini-pigs. After implantation, quantitative angiography (QA) was performed for calculation of artery and minimal luminal diameter. Follow-up was performed by QA and histomorphometry after 5 months.. Stent migration, stent fracture, or thrombus formation were not observed. All stents were patent at follow-up. Based on the location of the stent (iliac/femoral) and the stent-to-artery-ratio, stent segments were divided into "normal-sized" (stent-to-artery-ratio < 1.4, n = 12) and "oversized" (stent-to-artery-ratio ≥ 1.4, n = 9). All stent segments expanded to their near nominal diameter during follow-up. Normal-sized stent segments increased their diameter by 6% and oversized segments by 29%. A significant correlation between oversizing and restenosis by both angiography and histomorphometry was observed. Restenosis rates were similar for uncoated NS and TiNOX-coated NS.. TiNOX-coated NS are as safe and effective as uncoated NS in the porcine iliofemoral artery. All stents further expand to near their nominal diameter during follow-up. Oversizing is linearly and positively correlated with neointimal proliferation and restenosis, which may not be reduced by TiNOX-coating.

Topics: Alloys; Angiography; Animals; Arterial Occlusive Diseases; Femoral Artery; Iliac Artery; Linear Models; Random Allocation; Statistics, Nonparametric; Stents; Swine; Swine, Miniature

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; Arterial Occlusive Diseases; Female; Femoral Artery; Humans; Male; Popliteal Artery; Stents

We demonstrate feasibility of implantation of a self-expanding interwoven nitinol stent in a claudicant, where recanalization attempt of a heavily calcified, occluded superficial femoral artery (TASC D lesion) was complicated by a previously implanted, fractured standard stent. Wire passage through the occlusion and beyond the fractured stent could only be achieved through the subintimal space. A dedicated reentry device was used to allow distal wire entry into the true lumen at the level of the popliteal artery. Despite crushing of the fractured stent with a series of increasingly sized standard balloons, a significant recoil remainded in the area of the crushed stent. To secure patency of the femoro-popliteal artery we therefore decided to implant the novel self-expanding interwoven nitinol stent (Supera Veritas (TM), IDEV), whose unique feature is an exceptional high radial strength. Patient presented asymptomatic without any impairment of his walking capacity at three month follow up and duplex ultrasound confirmed patency of the stent. Subintimal recanalizations can be complicated by previously implanted stents, in particular in the presence of stent fracture, where intraluminal wire passage often can not be achieved. Considering the high radial strength and fracture resistance, interwoven nitinol stents represent a good treatment option in those challenging cases and they can be used to crush standard nitinol and ballonexpandable stents.

Topics: Aged; Alloys; Angioplasty, Balloon; Arterial Occlusive Diseases; Femoral Artery; Humans; Male; Prosthesis Design; Prosthesis Failure; Radiography; Retreatment; Stents; Time Factors; Ultrasonography, Doppler, Duplex; Vascular Patency

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

Topics: Aged, 80 and over; Alloys; Angiography, Digital Subtraction; Angioplasty, Balloon; Arterial Occlusive Diseases; Equipment Failure; Female; Femoral Artery; Follow-Up Studies; Humans; Magnetic Resonance Angiography; Stents; Ultrasonography, Doppler, Color; Varicose Ulcer; Venous Insufficiency

Topics: Aged; Alloys; Aneurysm, False; Angiography, Digital Subtraction; Arterial Occlusive Diseases; Constriction, Pathologic; Endovascular Procedures; Femoral Artery; Humans; Male; Prosthesis Design; Stents; Treatment Outcome

The nitinol stent has proven superior primary patency than balloon angioplasty in superficial femoral artery (SFA) lesions, but a systematic comparison of the patency of 2 different nitinol stents (S.M.A.R.T. and Luminexx) in patients with SFA lesions has not been done.. A multicenter, prospective database that included 511 consecutive patients who had undergone endovascular therapy with nitinol stenting for 638 limbs (S.M.A.R.T.: n=503; Luminexx: n=135) was retrospectively analyzed. Patency was assessed by duplex ultrasound. Outcomes were compared between the groups by the Kaplan-Meier and log-rank methods. To minimize the differences between each group, propensity-matched analysis was also performed. Stent fracture occurred in 11% (57/503) of the S.M.A.R.T. and 23% (31/135) of the Luminexx stents (P=0.0005). Despite a higher prevalence of chronic total occlusion (55% vs. 40%, P=0.002) and longer lesions (154±93mm vs. 135±71mm, P=0.03) in the S.M.A.R.T. group, there was no significant difference in patency for up to 5 years (P=0.50). When 119 lesions per group were assessed after propensity-matched analysis, the 5-year patency rate was 74% for the S.M.A.R.T. and 65% for the Luninexx stent (P=0.10).. Despite a different stent fracture rate, there was no significant difference in terms of patency between the S.M.A.R.T. and Luninexx stents for up to 5 years.

Topics: Alloys; Angioplasty, Balloon; Arterial Occlusive Diseases; Equipment Failure; Femoral Artery; Humans; Limb Salvage; Prevalence; Prosthesis Design; Radiography; Recurrence; Registries; Retrospective Studies; Stents; Ultrasonography, Doppler, Duplex; Vascular Patency

The aim of the present study was to assess the mid-term patency rate of nitinol stent implantation in patients with long superficial femoral artery (SFA) stenosis or occlusion. This is a retrospective, single-center study.. The data of 138 patients were retrospectively assessed in our center to determine the patency rate after nitinol stenting of the SFA.. Data for 165 limbs from 138 patients were collected. Each limb showed a long lesion with a total occlusion of >10 cm and mean lesion length of 20.35 ± 9.46 cm (range, 10-32 cm). Nitinol self-expanding stent implantations were performed in each limb. A total of 258 stents were implanted into 165 limbs (average, 1.56 stents/limb). Each patient received clinical and ultrasound/computerized tomographic angiography/magnetic resonance angiography evaluations before the procedure and underwent clinical status evaluation and an ankle-brachial index test at discharge and at 12, 24, and 36 months thereafter.. The initial technical success rate of revascularization was 91.51% (151/163). During follow-up, nine patients died because of myocardial infarction, cerebral infarction, and pneumonia, and 14 patients were lost to follow-up. The mean follow-up period for 150 limbs from 124 patients was 25.46 months (range, 6-51). During follow-up, 19 in-stent restenoses and 15 occlusions were diagnosed. In all, 30 re-interventions were performed, including six balloon angioplasties, three secondary cutting balloon angioplasties, 10 restenting procedures, four bypass surgeries, two bone marrow stem cell transplantations, and five limb amputations. Analysis showed the primary patency rates at 12, 24, and 36 months were 92.4%, 78.3%, and 62.1%, respectively, and the overall assisted-primary patency rates were 94.4%, 84.6%, and 75.8%, respectively.. Nitinol self-expanding stent implantation seems to be a good choice for older patients with long SFA occlusions. Although the short- and mid-term patency results were good, more observations are needed to assess its long-term efficiency.

Topics: Aged; Aged, 80 and over; Alloys; Amputation, Surgical; Angioplasty, Balloon; Ankle Brachial Index; Arterial Occlusive Diseases; China; Constriction, Pathologic; Critical Illness; Female; Femoral Artery; Humans; Ischemia; Kaplan-Meier Estimate; Limb Salvage; Magnetic Resonance Angiography; Male; Middle Aged; Prosthesis Design; Recurrence; Retrospective Studies; Stem Cell Transplantation; Stents; Time Factors; Tomography, X-Ray Computed; Treatment Outcome; Ultrasonography, Doppler, Color; Vascular Patency; Vascular Surgical Procedures

To assess outcomes in an elderly and diseased population after stenting in the femoropopliteal segment and evaluate risk factors for poor prognosis.. Retrospective study of femoropopliteal stents placed between March 2006 and January 2008. Patency was verified by duplex scanning. Risk factors associated with amputation or death and patency were analyzed using Cox regression.. A total of 117 limbs in 112 patients were observed for a median of 18 months. Median age of the patients was 79 years; 68% were treated for critical limb ischemia and 85% had occlusive lesions. Mean lesion length was 15.4 cm (SD: 9.2) and mean stented length was 19.7 cm (standard deviation: 9.8). At 1 year, primary patency was 63%, primary-assisted patency was 67%, and secondary patency was 69%. Stent diameter ≤6 versus 7 mm was a risk factor for loss of patency with a hazard ratio (HR) of 2.9 (95% CI: 1.1-7.7). Significant risk factors for death or amputation were as follows: HR for rest pain versus claudication was 5.9 (1.1-32.8), HR for tissue loss versus claudication was 5.8 (1.1-29.6), HR for stent diameter ≤6 versus 7 mm was 3.6 (1.0-12.3), and HR for 3-4 stents versus 1-2 was 2.6 (1.1-6.1).. Rutherford status is associated with death or amputation after stenting in the femoropopliteal segment. In addition, a smaller stent diameter and number of stents depict poorer prognosis independent of gender and anatomic level.

Topics: Age Factors; Aged; Aged, 80 and over; Alloys; Angioplasty; Arterial Occlusive Diseases; Chi-Square Distribution; Female; Femoral Artery; Humans; Ischemia; Kaplan-Meier Estimate; Limb Salvage; Male; Popliteal Artery; Proportional Hazards Models; Prosthesis Design; Recurrence; Registries; Retrospective Studies; Risk Assessment; Risk Factors; Stents; Sweden; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Duplex; Vascular Patency

Stent fracture with pseudoaneurysm formation in the femoropopliteal artery has uncommonly been reported. We present the case of a 72-year-old man with a fracture of self-expanding nitinol stent and a pseudoaneurysm formation in the suprageniculate popliteal artery. The popliteal artery was successfully reconstructed with a small saphenous vein graft interposition.

Topics: Aged; Alloys; Aneurysm, False; Angioplasty; Arterial Occlusive Diseases; Humans; Male; Popliteal Artery; Prosthesis Design; Prosthesis Failure; Saphenous Vein; Stents; Tomography, X-Ray Computed; Treatment Outcome; Vascular System Injuries

To evaluate performance characteristics of currently available superficial femoral artery (SFA) stents and stent delivery systems (SDS).. Six 7 mm/ 80 mm stent systems were included: BIOTRONIK Astron Pulsar (4F), EDWARDS LifeStent Flexstar, ev3 PROTÉGÉ Everflex, CORDIS Smart Control, BARD E-Luminexx, GUIDANT Absolute (all 6F). The SDS were evaluated for profile, flexibility in the stent region, trackability and pushability through a tortuous vessel model and release force during deployment. The stents were evaluated for flexibility, radial force during expansion and compression, and shortening.. The 4F system had a profile of 1.45 mm, and the 6F stent systems had a profile of 1.96 - 2.10 mm. The Astron Pulsar was most flexible (195 Nmm (2)) compared to 334 - 972 Nmm (2) for the 6F systems. The track force of the stiffest system (Flexstar, 0.314N) was higher than that of the Astron Pulsar (0.273N) but lower than that of the other systems (0.387 - 0.579N). The release force was 1.69N (Absolute), 2.05N (Astron Pulsar) up to 13.00N (Flexstar). The radial force for a 6 mm stent diameter during expansion ranged from 3.95N (Absolute) and 3.99N (Astron Pulsar) up to 7.22N (FlexStar) but was higher when compressed.. The 4F system had the best flexibility and trackability. The release force was high in most systems with release handles. The radial force of all tested stents covers a broad range. These results could be helpful to find the best stent for different lesions.

Topics: Alloys; Angioplasty; Arterial Occlusive Diseases; Biomechanical Phenomena; Compressive Strength; Femoral Artery; Humans; In Vitro Techniques; Models, Cardiovascular; Pliability; Prosthesis Design; Stents

We sought to investigate the timing of restenosis and the restenosis factors following nitinol stenting in the superficial femoral artery (SFA).. Restenosis following nitinol stenting in the SFA remains unsolved.. We analyzed 742 limbs in consecutive 585 patients who underwent successful endovascular therapy for de novo SFA lesions. Patency was assessed by duplex ultrasonography. Primary patency was defined as treated vessels without restenosis and secondary patency was defined as target vessels reopened by repeat revascularization. Receiver-operating characteristic (ROC) analysis was performed to delineate the timing of restenosis. Patients were subsequently classified into three groups: no restenosis, early restenosis, and late restenosis. Cox proportional hazard regression analyses were performed to explore the determinants of restenosis in each restenosis group.. Primary and secondary patency was 67 and 86% at 6 years, respectively. ROC curves indicated the 369th day was the best cutoff point distinguishing the early (144 limbs) and the late (42 limbs) restenoses. Sustained patency was observed in 556 limbs. After multivariate analysis, cilostazol (P = 0.0007) was negatively associated; female gender (P = 0.0071), diabetes mellitus (P = 0.0428), critical limb ischemia (P = 0.0435), and stent fracture (P = 0.0004) were positively associated with the early restenosis. Trans Atlantic Inter-Society Consensus II C/D was positively associated with both the early (P = 0.0017) and the late (P = 0.0359) restenoses.. Restenosis predominantly occurred within a year following nitinol stenting in the SFA, and the factors associated with the early restenosis were different from those with the late restenosis.

Topics: Aged; Aged, 80 and over; Alloys; Arterial Occlusive Diseases; Chi-Square Distribution; Constriction, Pathologic; Endovascular Procedures; Female; Femoral Artery; Humans; Japan; Kaplan-Meier Estimate; Male; Middle Aged; Proportional Hazards Models; Prosthesis Design; Recurrence; Retrospective Studies; Risk Assessment; Risk Factors; Stents; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Duplex; Vascular Patency

The aim of this study was to investigate the predictive value of clinical classification schemes that assess primary patency after self-expandable nitinol stent in the superficial femoral artery (SFA).. This study was a multicenter retrospective study of prospective databases. From April 2004 to December 2009, 1001 limbs (807 patients) that underwent successful nitinol stent implantation for de novo SFA lesions were identified and analyzed. Primary patency was defined as treated vessel without restenosis (defined as >2.4 of peak systolic velocity ratio by duplex) and repeat revascularization. Six items were included in the classification: female, diabetes, dialysis, critical limb ischemia (CLI), lesion length > 150 mm, and poor runoff; the FeDCLIP score. A lesion length >150 mm was scored as 2 points. The others were assigned 1 point each. The scores of 0 to 2, 3 to 4, and ≥5 points were classified as low-, moderate-, and high-risk patients, respectively. Outcome measures were primary and secondary patency and all-cause mortality up to 6 years in each risk group.. The mean follow-up interval was 26.8 ± 14.6 months. Primary patencies were 85.7%, 77.3%, and 74.2% in the low-risk group; 71.5%, 54.7%, and 51.9% in the moderate-risk group; and 53.0%, 24.3%, and 20.8% in the high-risk group at 1, 3, and 5 years, respectively. The secondary patencies were 94.6%, 92.3%, and 90.8% in the low-risk group; 89.5%, 83.1%, and 83.1% in the moderate-risk group; and 82.7%, 73.1%, and 73.1% in the high-risk group at 1, 3, and 5 years, respectively. There were significant differences in primary and secondary patency among the three risk groups (P < .0001 and P < .0001, respectively). Overall survival rates were 96.8%, 89.5%, and 81.8% in the low-risk group; 91.5%, 74.4%, and 68.7% in the moderate-risk group; and 78.2%, 63.2%, and 48.7% in the high-risk group at 1, 3, and 5 years, respectively. There were also significant differences in mortality (P < .0001).. New classification schemes based on FeDCLIP score were useful for risk stratification in vessel patency and mortality after self-expandable nitinol stenting for SFA disease.

Topics: Aged; Aged, 80 and over; Alloys; Angioplasty; Arterial Occlusive Diseases; Chi-Square Distribution; Constriction, Pathologic; Diabetes Complications; Female; Femoral Artery; Health Status Indicators; Humans; Ischemia; Japan; Kaplan-Meier Estimate; Male; Middle Aged; Predictive Value of Tests; Prosthesis Design; Registries; Renal Dialysis; Retrospective Studies; Risk Assessment; Risk Factors; Severity of Illness Index; Sex Factors; Stents; Time Factors; Treatment Outcome; Vascular Patency

Topics: Alloys; Arterial Occlusive Diseases; Endovascular Procedures; Female; Femoral Artery; Humans; Male; Stents

To report a prospective, single-arm, multicenter clinical study evaluating the Zilver PTX drug-eluting stent for treating the above-the-knee femoropopliteal segment (NCT01094678; http://www.clinicaltrials.gov ).. The Zilver PTX drug-eluting stent is a self-expanding nitinol stent with a polymer-free paclitaxel coating. Patients with symptomatic (Rutherford category 2-6) de novo or restenotic lesions (including in-stent stenosis) of the above-the-knee femoropopliteal segment were eligible for enrollment. Between April 2006 and June 2008, 787 patients (578 men; mean age 66.6±9.5 years) were enrolled at 30 international sites.. Nine hundred lesions (24.3% restenotic lesions of which 59.4% were in-stent stenoses) were treated with 1722 Zilver PTX stents; the mean lesion length was 99.5±82.1 mm. The 12-month Kaplan-Meier estimates included an 89.0% event-free survival rate, an 86.2% primary patency rate, and a 90.5% rate of freedom from target lesion revascularization. There were no paclitaxel-related adverse events reported. The 12-month stent fracture rate was 1.5%. The ankle-brachial index, Rutherford score, and walking distance/speed scores significantly improved (p<0.001) from baseline to 12 months.. These results indicate that the Zilver PTX drug-eluting stent is safe for treatment of patients with de novo and restenotic lesions of the above-the-knee femoropopliteal segment. At 1 year, the overall anatomical and clinical effectiveness results suggest that this stent is a promising endovascular therapy.

Topics: Aged; Alloys; Arterial Occlusive Diseases; Canada; Cardiovascular Agents; Constriction, Pathologic; Disease-Free Survival; Drug-Eluting Stents; Endovascular Procedures; Europe; Female; Femoral Artery; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Paclitaxel; Popliteal Artery; Prospective Studies; Prosthesis Design; Recovery of Function; Recurrence; Republic of Korea; Severity of Illness Index; Time Factors; Treatment Outcome; Vascular Patency

To evaluate safety and results of the Freepac drug-eluting balloon (DEB) technology for the treatment of chronic femoropopliteal steno-occlusions.. In a multicentre registry we enrolled 66 patients with symptomatic femoropopliteal stenosis and/or occlusion <15 cm (Rutherford stages 2 to 4). Patients were treated first with an undersized uncoated balloon and then with an appropriate sized DEB. In case of unsatisfactory results, nitinol stents were implanted. Clinical evaluations and echo-duplex were performed at baseline, at discharge, and at three months after intervention. Procedural success was 100%. Stents were implanted in 10.8% of the patients. At three months follow-up, the mean ankle-brachial index (ABI) significantly improved from 0.58 ± 0.13 to 0.82 ± 0.25, thus resulting in a Rutherford class improvement (p <0.01) and amelioration of the claudication distance (102 ± 87 vs. 403 ± 160 meters) (p<0.001). No serious adverse events occurred during the follow-up.. The results of this registry demonstrate the safety of mediated paclitaxel elution for the prevention of restenosis in the superficial femoral and popliteal arteries after angioplasty. This technique was associated with encouraging results in terms of clinical improvement as well as a lack of adverse events, including target lesion revascularisation, at three months.

Topics: Adult; Aged; Aged, 80 and over; Alloys; Angioplasty, Balloon; Ankle Brachial Index; Arterial Occlusive Diseases; Cardiovascular Agents; Coated Materials, Biocompatible; Constriction, Pathologic; Drug Delivery Systems; Equipment Design; Female; Femoral Artery; Humans; Italy; Male; Middle Aged; Paclitaxel; Popliteal Artery; Prospective Studies; Prosthesis Design; Recurrence; Registries; Stents; Time Factors; Treatment Outcome

The aim of the study was to investigate long-term incidence of stent fractures and patency after femoropopliteal stenting.. Sixty consecutive patients (mean age 70 + or - 7 years) were treated with implantation of single (31 patients) or multiple (29 patients) self-expandable nitinol SMART stents (Cordis, Miami, Florida, USA; mean stent length 108.8 + or - 73 mm) between year 2000 and 2005. At a mean follow-up of 66 + or - 20 months, 37 patients (85% men, mean age 71 + or - 7 years) were alive and underwent plain radiograph and color-coded duplex sonography. A peak systolic velocity was measured proximally, intrastent and distally.. Stent fractures were detected by radiograph in three of the 39 (7.7%) legs (mean stented segment 207 + or - 64 mm). In one case, a moderate strut fracture was associated with in-stent occlusive restenosis confirmed by angiography. Color-coded duplex sonography revealed a mean in-lesion peak systolic velocity of 73 + or - 35 cm/s, six (15%) in-stent restenoses and four (11%) total occlusions. Primary patency rate 5 years after nitinol SMART stent implantation was 74.6%. Patients symptomatic for claudication or presenting with diagnosis of in-stent restenosis underwent angiography.. Long-term femoral SMART stenting showed minimal incidence of fractures compared with previously published data with different stent types. In-stent restenosis and occlusive restenosis seem to be correlated with stented segment length.

Topics: Aged; Aged, 80 and over; Alloys; Angioplasty; Arterial Occlusive Diseases; Blood Flow Velocity; Constriction, Pathologic; Equipment Failure Analysis; Female; Femoral Artery; Humans; Italy; Male; Popliteal Artery; Prosthesis Design; Prosthesis Failure; Radiography; Recurrence; Regional Blood Flow; Stents; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Color; Vascular Patency

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

Long-term clinical outcomes after femoropopliteal (FP) stenting with nitinol stents have not yet been clear. We investigated the mid-term efficacy of FP stenting with nitinol stents.. This study was a multicenter retrospective study. From April 2004 to December 2008, 511 consecutive patients (639 limbs; mean age 71 +/- 7 years; 71% male) who underwent successful FP stenting with nitinol stents for de novo lesions were retrospectively selected and analyzed in this multicenter study. All patients had a minimum follow-up of 6 months. Restenosis was defined as >2.4 of peak systolic velocity ratio by duplex or >50% stenosis by angiogram. Primary patency was defined as treated vessels without restenosis and repeat revascularization. Secondary patency was defined as target vessels that become totally occluded and are reopened by repeat revascularization.. Sixty-one percent of the patients had diabetes, 76% were claudicant, and 20% were on hemodialysis. Mean lesion length was 151 +/- 75 mm. Mean follow-up period was 22 +/- 11 months. Primary patency was 79.8%, 66.7%, and 63.1%, and secondary patency was 90.4%, 87.3%, and 86.2% at 1, 3, and 5 years, respectively. During the follow-up period, 53 patients (10%) died. Of them, cardiovascular death was 38% and stent fracture had occurred in 14%. On multivariate analysis by Cox proportional hazard ratio, cilostazol administration (hazard ratio [HR], 0.52;P < .0001), stent fracture (HR, 1.6; P = .03), hemodialysis (HR, 1.7; P = .01), and Trans Atlantic Inter-Society Consensus (TASC) II class C/D (HR, 2.4; P < .0001) were the independent predictors of primary patency after successful FP stenting.. Clinical efficacy of nitinol stent implantation for FP disease was favorable for up to 5 years.

Topics: Adult; Aged; Aged, 80 and over; Alloys; Angioplasty, Balloon; Arterial Occlusive Diseases; Chi-Square Distribution; Constriction, Pathologic; Female; Femoral Artery; Humans; Japan; Kaplan-Meier Estimate; Male; Middle Aged; Popliteal Artery; Proportional Hazards Models; Prosthesis Design; Radiography; Recurrence; Retrospective Studies; Risk Assessment; Risk Factors; Stents; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Duplex; 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

Topics: Alloys; Angioplasty, Balloon; Arterial Occlusive Diseases; Cost Control; Drug-Eluting Stents; Femoral Artery; Humans; Popliteal Artery; Prosthesis Implantation; Randomized Controlled Trials as Topic; Selection Bias

Percutaneous revascularization of superficial femoral artery (SFA) is increasingly carried out to treat patients with peripheral vascular disease and either intermittent claudication or critical limb ischemia. Transradial vascular access is increasingly adopted for invasive procedures due to reduced access-site complications and improved patient's comfort, compared with transfemoral. However, compared with coronary interventions, the adoption of transradial access in peripheral procedures is limited. Concerning SFA interventions, transradial access is usually prevented by the distance between the vascular access and the target lesion, which extends over the length of the currently available devices. Thanks to technical improvements, resulting in specifically dedicated low-profile equipment with adequate shaft length availability, transradial access is now feasible for the treatment of selected SFA lesions. We report the first two cases of SFA stenting performed by transradial access with a new specifically developed self-expanding nitinol stent with extended delivery system length. This report suggests that, with proper technique and specifically dedicated equipment, transradial SFA stenting is feasible. Treatment of SFA disease by transradial route, allowing for immediate post-procedure walking and simultaneous bilateral interventions, may represent an alternative for effective treatment of selected patients with SFA lesions.

Topics: Alloys; Angioplasty, Balloon; Arterial Occlusive Diseases; Catheters; Constriction, Pathologic; Equipment Design; Femoral Artery; Humans; Male; Middle Aged; Prosthesis Design; Radial Artery; Radiography; Stents; Treatment Outcome

Topics: Alloys; Angioplasty, Balloon; Arterial Occlusive Diseases; Catheters; Constriction, Pathologic; Equipment Design; Femoral Artery; Humans; Prosthesis Design; Radial Artery; Radiography; Stents; Treatment Outcome

To evaluate the prevalence, factors, and clinical impact of self-expanding stent fracture following iliac artery stenting.. A review of the endovascular registry database for our department showed 353 patients with occlusive diseases of the iliac artery who underwent stenting between 1997 and 2007. While clinical data and images were retrospectively reviewed for all patients, 165 patients who underwent self-expanding stenting and plain radiograph with >or=6-months follow-up were analyzed. Mean follow-up was 43 months for 305 stents (elgiloy, n = 83; nitinol, n = 222) implanted in 216 iliac arteries. The mean duration until the last imaging study was 38 months. Items concerning prevalence of stent fracture, factors associated with fracture, and outcomes for patients with stent fracture were analyzed.. Stent fracture was detected in 11 of 216 iliac arteries (5.1%). In stent-based analysis, 11 of 305 stents (3.6%) showed stent fracture, classified as type I in 2 stents, type II in 3 stents, type III in 4 stents, type IV in 1 stent, and type V in 1 stent. Stent fracture was detected in 11 of 222 nitinol stents (5.0%), but no Elgiloy stents. Cox proportional hazards regression model indicated stenting for chronic occlusion as a risk factor associated with nitinol stent fracture (hazard ratio [HR] = 6.09, P = 0.008, 95% confidence interval [CI] 1.59-23.3). Cumulative primary patency rates in iliac arteries with and without fractured stents were 90% and 91% at 8 years (P = .80), respectively.. Fracture of self-expanding stents is rare in iliac arteries, but stenting for chronic occlusion represents a risk factor for fracture. Fractures of stents placed in iliac arteries rarely affect patency.

Topics: Aged; Alloys; Angioplasty, Balloon; Arterial Occlusive Diseases; Chronic Disease; Equipment Failure Analysis; Female; Humans; Iliac Artery; Male; Middle Aged; Proportional Hazards Models; Prosthesis Design; Prosthesis Failure; Radiography; Registries; Retrospective Studies; Risk Assessment; Risk Factors; Stents; Time Factors; Treatment Failure; Vascular Patency

To evaluate the effectiveness of nitinol stent placement in long infrapopliteal lesions in patients with critical limb ischaemia.. Between January 2005 and January 2008, 34 high-risk patients (18 female; mean age: 73.8+/-6.1 years) with critical limb ischaemia underwent infragenicular stenting. They had serious cardiovascular co-morbidities (>3, such as chronic obstructive pulmonary disease (COPD), congestive heart failure and coronary artery occlusive disease), American Society of Anaesthesiologists score of 3 or more, previous myocardial infarction, coronary stent or bypass. The mean stenosis length was 6.5+/-0.9 cm (range: 2.2-8 cm), and the mean occlusion length was 7.5+/-2.9 cm (range: 3-9.6 cm). Primary stent implantation was performed for long stenosis or occlusion based on the TransAtlantic InterSociety Consensus (TASC) C and D classification, secondary stenting for flow-limiting dissections or elastic recoil after balloon dilatation. All patients who returned to the outpatient clinic were assessed for claudication by clinical examination, ankle-brachial index (ABI) measurements, colour flow and duplex Doppler ultrasound (US). Digital subtraction angiography was performed if restenosis or re-occlusion was identified by Doppler US or transcutaneous measurement of partial oxygen pressure (TcpO(2)) measurements, when appropriate.. The technical success rate was 97.1% (33 of 34 cases). The crude rate of primary patency rate was 91.1% during a follow-up period of 10.4+/-7.3 months. The mean ankle-brachial index increased significantly following intervention (0.45+/-0.25-0.92+/-0.13, p<0.001). Two patients underwent successful redo angioplasty after tibioperoneal interventions due to in-stent restenosis (>70%) with relevant limitation of pain-free walking distance. In another patient, bypass surgery to the anterior tibial artery 6 months after primary intervention was necessary due to rest pain. Two patients required surgical revision of the femoral artery after antegrade access. No procedure-related death was recorded in the entire follow-up period.. The mid-term outcome underscores infrapopliteal stent placement as a reliable treatment option in patients with critical limb ischaemia. In patients at high risk for crural bypass, with no flow-limiting supragenicular lesions, below-knee stent-supported angioplasty should be considered as a first choice of treatment.

Topics: Aged; Alloys; Angiography, Digital Subtraction; Angioplasty, Balloon; Ankle; Arterial Occlusive Diseases; Blood Gas Monitoring, Transcutaneous; Blood Pressure; Brachial Artery; Constriction, Pathologic; Critical Illness; Feasibility Studies; Female; Humans; Ischemia; Lower Extremity; Male; Patient Selection; Popliteal Artery; Prosthesis Design; Recurrence; Regional Blood Flow; Retrospective Studies; Risk Assessment; Stents; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Color; Vascular Patency

Topics: Alloys; Angioplasty, Balloon; Arterial Occlusive Diseases; Constriction, Pathologic; Critical Illness; Hemodynamics; Humans; Ischemia; Lower Extremity; Patient Selection; Popliteal Artery; Prosthesis Design; Recurrence; Risk Assessment; Stents; Time Factors; Treatment Outcome; Vascular Patency

It has been reported that nitinol stents provide higher patency in chronic phase than stainless steel stents after intervention to superficial femoral artery (SFA). However, there are few reports about stent patency for chronic total occlusion of SFA (SFA CTO).. To compare clinical outcomes of self-expanding nitinol stents and stainless steel stents after percutaneous peripheral intervention (PPI) for SFA CTO.. Between April 2004 and August 2007, a total of 25 SFA CTO lesions (nitinol stent group, 13; stainless steel stent group, 12) in 21 patients were treated with PPI, all patients were followed clinically, and 21 lesions (nitinol, 9; stainless steel, 12) received follow-up angiography. There was no significant difference in baseline characteristics, mean stent diameter (7.3+/-0.7 mm vs. 6.9+/-1.2 mm, p=0.32), pre-ankle-brachial index (ABI), and Fontaine stage between groups. Mean occlusion length and stent length were significantly longer (129.5+/-54.9 mm vs. 39.0+/-20.6 mm, 250.8+/-90.0 mm vs. 145.2+/-64.6 mm, respectively, p<0.01) and number of stents was significantly larger (2.8+/-0.9 vs. 1.6+/-0.5, p<0.01) in the nitinol stent group. At follow-up, ABI was significantly lower (0.73+/-0.20 vs. 0.95+/-0.13, p=0.04), restenosis rate and target lesion revascularization was significantly higher (58.3% vs. 15.4%, p=0.03; 50.0% vs. 7.7%, p=0.02, respectively) in the stainless steel stent group.. Our study demonstrates the superiority of nitinol stent implantation compared with stainless steel stent implantation for SFA CTO.

Topics: Aged; Aged, 80 and over; Alloys; Angioplasty; Arterial Occlusive Diseases; Chronic Disease; Drug-Eluting Stents; Female; Femoral Artery; Follow-Up Studies; Humans; Male; Middle Aged; Radiography; Stainless Steel; Treatment Outcome

An increasing spectrum of complex peripheral arterial disease may be successfully treated using percutaneous revascularization techniques. A pair of challenging peripheral revascularization procedures in patients with critical limb ischemia is presented, where an array of interventional tools and techniques were required, and the off-label use of the Boomerang catalyst system closure device was important in managing a variety of complex arterial access issues and ultimately allowing procedural success.

Topics: Aged; Alloys; Amputation, Surgical; Angiography, Digital Subtraction; Angioplasty, Balloon; Anticoagulants; Arterial Occlusive Diseases; Coated Materials, Biocompatible; Constriction, Pathologic; Critical Illness; Equipment Design; Female; Hemostatic Techniques; Hemostatics; Humans; Ischemia; Leg; Male; Middle Aged; Stents; Treatment Outcome

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

We investigated the time course of stent patency in the femoro-popliteal artery for as long as 4 years.. Stent fracture has been related to poor 2-year patency in the femoro-popliteal artery.. We studied 239 consecutive patients who underwent provisional de novo stenting with nitinol stents for 333 limbs (Luminexx stent [C. R. Bard, Inc., Murray Hill, New Jersey] in 91 limbs; Smart stent [Cordis Corp., Miami Lakes, Florida] in 242 limbs) from April 2004 to December 2007. Stent fracture was determined by X-ray with multiple projections. Patency was assessed by duplex ultrasonography as peak systolic velocity ratio <2.4 or by angiography (% diameter stenosis <50%). Primary patency in those with and without stent fracture at follow-up was assessed along with factors influencing stent fracture.. Primary patency was 81%, 74%, 68%, and 65% at 1, 2, 3, and 4 years, respectively. Stent fracture occurred in 14% (78 of 544) per stent and 17% (55 of 333) per limbs. Stent fracture was significantly associated with multiple stent deployments (with fracture = 2.3 +/- 0.9 stents vs. without fracture = 1.5 +/- 0.7 stents, p < 0.001) and long lesions (with fracture = 208 +/- 84 mm vs. without fracture = 121 +/- 79 mm, p < 0.001). Primary patency was 68% with fracture versus 83% without fracture at 1 year, p = 0.03; 65% versus 75% at 2 years, p = 0.05; 61% versus 69% at 3 years, p = 0.06; and 61% versus 65% at 4 years, p = 0.07. Neither type 1 nor type 3 fracture affected patency, although type 2 showed the worst patency.. Stent fracture worsened the patency during the first 2 years, but it did not apparently affect patency beyond 2 years. In particular, complete stent separation did not affect patency.

Topics: Aged; Aged, 80 and over; Alloys; Angioplasty, Balloon; Arterial Occlusive Diseases; Constriction, Pathologic; Female; Femoral Artery; Humans; Kaplan-Meier Estimate; Male; Popliteal Artery; Prosthesis Design; Prosthesis Failure; Radiography; Retrospective Studies; Severity of Illness Index; Stents; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Duplex; Vascular Patency

In the endovascular therapy for the superficial femoral artery (SFA) a variety of stent devices can be used. Indications for endovascular intervention are increasing, since the 2007 TASC II consensus changed. Several, also multicentric -trials, evaluated the use and effectiveness of stent devices.. The present trial studied efficacy of long ev3 Protégé Everflex stents used in the treatment of long and complex occlusive lesions of the -superficial femoral artery (SFA) and the popliteal artery.. The ev3 Protégé Everflex device (ev3 Inc., Plymouth, MN, USA) is a self-expandable nitinol stent consisting of a helical structure with spiral cell interconnections, making high flexibility and low fragility possible. Using a prospective follow-up programme, 103 consecutive patients who received 128 stents (150 mm average length) were included in this study. Pre- and postinterventional parameters were walk-ing distance, ABI, Rutherford categorisation and duplex ultrasound examination. In addition, stent fracture was excluded by radiograms. The mean follow-up period was 6 months.. 128 stents were implanted in 103 patients. The average age was 71.1 years (range: 52-90 years). 44 % of the collective suffered from TASC II C and D lesions. The technical success was 100 %. Restenosis was found in 11.8 % of the cases (n = 16) and recanalised (n = 9). 4 bypass implantations and 2 major amputations were performed. A total of 6 stent fractures was found (4.7 %).. The Protégé stent is a safe device with favourable short-term results. Restenosis and fracture rates are low, but long-term results still have to be evaluated in the future.

Topics: Aged; Aged, 80 and over; Alloys; Angioplasty, Balloon; Arterial Occlusive Diseases; Equipment Failure Analysis; Exercise Test; Female; Femoral Artery; Follow-Up Studies; Humans; Male; Middle Aged; Pliability; Prosthesis Design; Recurrence; Reoperation; Stents; Treatment Outcome; Ultrasonography, Doppler, Duplex

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

Although in clinical practice endovascular therapy (EVT) with a nitinol stent for femoro-popliteal artery (FPA) lesions has been widely applied for TASC II A/B lesions, primary patency beyond 2 years remains unknown, as do the factors associated with restenosis.. A prospectively maintained database that included 189 limbs treated with nitinol stents for de novo TASC II A/B FPA lesions was retrospectively analyzed. The outcomes were overall primary and secondary patency during the follow-up period and predictors associated with restenosis. Primary patency overall with nitinol stents was 84%, 82%, 80%, 80% and secondary patency was 96%, 93%, 90%, 90% at 12, 24, 36, 48 months, respectively. Primary patency was not statistically different between the 2 types of nitinol stents (Luminexx vs S.M.A.R.T. Control. stent, P=0.37) during follow-up period. From the multivariate analysis, administration of cilostazol was the strongest independent factor associated with restenosis (P=0.0012).. Nitinol stent implantation for TASC II A/B FPA lesions is suitable and durable in sustaining freedom from restenosis through 4 years of follow-up.

Topics: Aged; Aged, 80 and over; Alloys; Angioplasty, Balloon; Arterial Occlusive Diseases; Female; Femoral Artery; Humans; Male; Middle Aged; Popliteal Artery; Retrospective Studies; Stents; Time Factors; Treatment Outcome; Vascular Patency

Although percutaneous transluminal angioplasty (PTA) has become a common therapeutic standard for peripheral artery disease (PAD), high restenosis rates in the superficial femoral artery (SFA) remain a major problem. Nitinol stent implantation is reported to reduce restenosis in SFA after PTA in the general population; however, little is known about whether the nitinol stent improves primary patency after PTA in hemodialysis patients who are at higher risk of revascularization failure. The aim of this study was to clarify the effects of nitinol stent implantation for primary patency in SFA after PTA in hemodialysis patients with PAD.. Eighty consecutive hemodialysis patients (167 SFA lesions) who underwent PTA with nitinol stents from January 2006 to January 2008 were compared with 64 hemodialysis patients (128 SFA lesions) who received stainless steel stents in the preceding 2 years. In the follow-up study to 2 years, incidence of restenosis, amputation, and all-cause mortality were analyzed. End points between the groups were examined with the Kaplan-Meier and log-rank methods. Prognostic values for end points were calculated by a Cox univariate analysis and Cox multivariable regression models. To statistically minimize the differences in each stent group, a propensity-matched analysis was also performed using the model including male gender, age, diabetes, hypertension, hyperlipidemia, smoking, incidence of ulcer/gangrene, and TransAtlantic Inter-Society Consensus (TASC) type C+D.. The 2-year primary patency rate was 58% in the nitinol group vs 42% in the stainless steel group (hazard ratio [HR], 0.58; 95% confidence interval [CI], 0.39-0.84; P = .0045), despite a higher prevalence of TASC C+D lesion in the nitinol group (68% vs 49%, P = .0014). In 108 lesions matched after propensity score analysis, the primary patency for 2 years was 64% in the nitinol group vs 42% in the stainless steel group (HR, 0.39; 95% CI, 0.24-0.65; P = .0003). Cox multivariate models showed nitinol stent (HR, 0.42; 95% CI, 0.25-0.73; P = .002), age (HR, 1.04; 95% CI, 1.01-1.08; P = .031), and incidence of ulcer/gangrene (HR, 2.35; 95% CI, 1.17-4.75; P = .017) were independent predictors of restenosis.. These data suggest that nitinol stent implantation improves primary patency in SFA after PTA compared with the stainless steel stent, even in hemodialysis patients with PAD.

Topics: Aged; Alloys; Angioplasty, Balloon; Arterial Occlusive Diseases; Constriction, Pathologic; Female; Femoral Artery; Graft Occlusion, Vascular; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Proportional Hazards Models; Prosthesis Design; Renal Dialysis; Retrospective Studies; Risk Assessment; Risk Factors; Stainless Steel; 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

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

Topics: Alloys; Angioplasty, Balloon; Arterial Occlusive Diseases; Device Removal; Equipment Design; Femoral Artery; Foreign-Body Migration; Foreign-Body Reaction; Giant Cell Arteritis; Hemorrhage; Hemostatic Techniques; Humans; Patient Selection; Pressure; Punctures; Risk Factors; Skin Diseases; Ultrasonography

We report the first case of a transcutaneous migration of a vascular clip closure device 10 weeks after placement during femoral artery puncture for percutaneous transluminal angioplasty. We postulate focal inflammatory vascular wall changes as the predisposing factor in this patient with giant cell arteritis.

Topics: Aged; Alloys; Angioplasty, Balloon; Arterial Occlusive Diseases; Device Removal; Equipment Design; Female; Femoral Artery; Foreign-Body Migration; Foreign-Body Reaction; Giant Cell Arteritis; Hemorrhage; Hemostatic Techniques; Humans; Punctures; Risk Factors; Skin Diseases; Ultrasonography

To report an unusual case of dramatic nitinol stent strut fractures with resultant complete loss of stent integrity in a cadaveric lower limb graft.. A 73-year-old man had the clinical stigmata of graft versus host response to a cadaveric femoral-tibioperoneal graft and suspected inflammation-induced stent corrosion culminating in fracture. The long continuous stented segment and station of the distal anastomosis below the knee resulted in preferential displacement of force to the proximal stent edge as the knee bends, making mechanical stress the most likely primary cause for these findings.. This case provides insight into some of the unique mechanical issues in vessels traversing the knee joint and how the problem is amplified by increasing the distance between the knee (fulcrum) and the stented vessel (lever arm). This lever-arm effect would also apply to the native superficial femoral artery when vessel compliance is changed by multiple stents.

Topics: Aged; Alloys; Amputation, Surgical; Angiography; Arterial Occlusive Diseases; Blood Vessel Prosthesis Implantation; Femoral Artery; Graft vs Host Disease; Humans; Leg; Male; Prosthesis Failure; Stents; Thrombectomy; Tibial Arteries

The feasibility of self-expanding nitinol stents for treatment of infragenicular arteries following unsuccessful balloon angioplasty was assessed. Options for lower limb percutaneous revascularization are limited, especially for complex vessel obstruction. Depending on the lesion and the experience of the interventionalist, the failure rate of balloon angioplasty (PTA) ranges between 10 and 40%. Until recently, no self-expanding stent for the use in the infragenicular arteries was available. This is the first report of the results for 18 consecutive patients who received 4F sheath compatible self-expanding nitinol stents following unsuccessful PTA or early restenosis. Twenty-four stents were implanted in 21 lesions for various indications residual stenosis >50% due to heavy calcification, flow-limiting dissection, occluding thrombus resistant to thrombolyis, thrombaspiration, and PTA, and early restenosis after previous PTA. Stent implantation was feasible in all cases. No complications occurred. After the stent implantation, all primarily unsuccessful interventions could be transformed into successful procedures with no residual stenosis >30% in any case. After 6 +/- 2 months, two of the 18 patients died, and 14 of the 16 remaining patients improved clinically. At follow-up, the patency could be assessed in 14 stented arteries. Three stents were occluded, one stent showed some neointimal hyperplasia (50-70% restenosis), the remaining ten stents showed no restenosis (0-30%). The use of self-expanding nitinol stents in tibioperoneal and popliteal arteries is a safe and feasible option for the treatment of unsuccessful PTA. The 6-months patency is high.

Topics: Aged; Aged, 80 and over; Alloys; Angioplasty, Balloon; Arterial Occlusive Diseases; Feasibility Studies; Female; Humans; Leg; Male; Middle Aged; Peripheral Vascular Diseases; Prospective Studies; Radiography, Interventional; Stents; Treatment Outcome; Ultrasonography, Interventional; Vascular Patency

Topics: Alloys; Angiography, Digital Subtraction; Angioplasty, Balloon; Arterial Occlusive Diseases; Blood Vessel Prosthesis Implantation; Femoral Artery; Humans; Polytetrafluoroethylene; Prosthesis Design; Prosthesis Failure; Stents; Treatment Outcome

Topics: Alloys; Angioplasty, Balloon; Arterial Occlusive Diseases; Blood Vessel Prosthesis Implantation; Femoral Artery; History, 20th Century; History, 21st Century; Humans; Patient Selection; Polytetrafluoroethylene; Practice Guidelines as Topic; Prosthesis Design; Severity of Illness Index; Stents; Treatment Outcome

To evaluate the initial and mid-term results of a new self-expanding low strut profile nitinol stent for treatment of atherosclerotic lesions stenoses and occlusions in the superficial femoral artery (SFA).. In 8 patients (4 male, 4 female, mean age 74.8 +/- 8.8 years) with SFA lesions and non-satisfying results after PTA treatment alone, 10 self-expanding nitinol Xpert stents were deployed via a 4 F sheath. Stent characteristics and handling were graded by the interventionalist. Fontaine classification, duplex flow measurements and ankle brachial index (ABI) at rest and stress were taken prior and one day after stent placement. Patients were followed 3, 6 and 12 months after the procedure obtaining the same parameters at each appointment.. Initial stent treatment was successful in all patients. Stent handling and positioning were rated very good and safe. All patients improved clinically by at least one Fontaine stage (range before treatment: stage IIb to IV). The mean ABI at rest (stress) improved initially from 0.68 (0.70) to 1.07 (0.99). During a mean follow-up period of 8.3 months no case of clinically relevant in-stent stenosis was observed with stable values of ABI at rest and stress.. Treatment of SFA lesions using the 4F-compatible self-expanding nitinol Xpert stent is technically simple, safe and shows good initial and mid-term results.

Topics: Aged; Aged, 80 and over; Alloys; Angioplasty, Balloon; Arterial Occlusive Diseases; Atherosclerosis; Cohort Studies; Equipment Design; Female; Femoral Artery; Follow-Up Studies; Humans; Male; Middle Aged; Prospective Studies; Radiography; Stents

Topics: Alloys; Arterial Occlusive Diseases; Blood Vessel Prosthesis; Blood Vessel Prosthesis Implantation; Femoral Artery; Humans; Meta-Analysis as Topic; Polytetrafluoroethylene; Popliteal Artery; Prosthesis Design; Research Design; Saphenous Vein; Stents; Treatment Outcome; Vascular Patency

To compare the efficacy of subintimal angioplasty combined with primary stenting to intraluminal angioplasty with stenting for revascularization of long (>10 cm) femoropopliteal arterial occlusions.. Baseline characteristics and outcomes of 52 patients (40 men; mean age 65.6+/-9.7 years) with superficial femoral artery (SFA) occlusions in 61 limbs (mean occlusion length 22.7+/-9.9 cm) treated with subintimal angioplasty and primary stenting were compared with a 54-patient control group (46 men; mean age 64.8+/-8.2 years) from our registry database who had intraluminal angioplasty with stenting in 60 limbs (mean occlusion length 22.0+/-8.5 cm).. All baseline clinical and angiographic characteristics showed no differences. In all patients, at least 1 self-expanding nitinol stent was implanted. Subintimal angioplasty was successful in 58 (95.1%) of 61 limbs, whereas technical success for the conventional approach was 86.7% (52/60 limbs; p = 0.11). In both groups, there were no major complications requiring surgery. Primary patency at 12 months for successful cases was 76.4% for subintimal angioplasty and 59.2% for conventional angioplasty (p = 0.06); on an intention-to-treat basis, including technical failures, the rates were 72.4% and 50.9%, respectively (p = 0.02).. Subintimal angioplasty combined with stenting was feasible, with a high technical success rate and better short and midterm results for revascularization of long femoropopliteal occlusions than the conventional intraluminal approach.

Topics: Aged; Alloys; Angioplasty, Balloon; Arterial Occlusive Diseases; Feasibility Studies; Female; Femoral Artery; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Popliteal Artery; Prospective Studies; Prosthesis Design; Radiography; Registries; Retrospective Studies; Stents; Time Factors; Treatment Outcome; Tunica Intima; 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

Since long-term patency and device integrity of nitinol stents in SFA lesions are not well studied, we examined clinical outcome, patency and device integrity after stenting long lesions using a standardized implantation technique.. Between 2001 and 2006, 59 patients (74 lesions) were treated with the same nitinol self-expandable stent (Zilver, Cook, USA) and technique for SFA recanalization. Clinical charts and imaging were retrospectively reviewed for patency (primary and assisted-primary), and device integrity.. Patients were 74.5 (10.9) years old (range 49 to 93), 64% male, 42% diabetic, 62% hypertensive and 67% current or former smokers. Lesions were 23% TASC B, 16% TASC C, or 61% TASC D. Mean recanalization length was 19 cm (range 3 to 53). Mean number of stents per patient was 2.8 (total 210). Mean follow-up time was 2.4 years (range 3 days to 4.8 years). Kaplan-Meier estimates for primary patency rates were 90%, 78%, 74%, 69%, and 69% at 1, 2, 3, 4 and 4.8 years, respectively. Ten restenoses at a mean of 500 (388) days (1-1251 days) were successfully recanalized. The assisted primary patency rates were 96%, 90%, 90%, 90% and 90% at 1, 2, 3, 4 and 5 years, respectively. Six complete occlusions could not be reverted by a second recanalization procedure, and were treated by surgical bypass (1 case), amputation (3 cases), or medical management (2 cases). One (1.04%) Class II stent fracture was noted.. SFA recanalization with a standardized implantation technique and nitinol stents provides good long-term primary and assisted-primary patency.

Topics: Aged; Aged, 80 and over; Alloys; Angioplasty, Balloon; Arterial Occlusive Diseases; Equipment Failure; Female; Femoral Artery; Follow-Up Studies; Humans; Ischemia; Leg; Male; Middle Aged; Retreatment; Retrospective Studies; Stents

The aim of the paper was to investigate the performance of the ABSOLUTE .035 Peripheral Self-Expanding Stent System in preventing restenosis of superficial femoral or proximal popliteal arteries. Due to a lack of large controlled trials proving its long-term durability femoropopliteal artery stenting is still a matter of debate. In this paper we report the study design, the acute and short-term results of a prospective European registry on the treatment of TASC B and C femoropopliteal lesions with the use of the ABSOLUTE stent.. This prospective, non-randomized, multi-centre study enrolled 122 patients with symptomatic peripheral occlusive disease at 14 sites in Europe. Patients were included with obstructed femoropopliteal arteries. Key inclusion criteria were de novo lesions > or = 4.0 mm and < or = 7.0 mm in diameter, and > or = 40 mm and < or = 200 mm in length. Single target vessel treatment had to be performed with a maximum of three stents.. Mean target lesion length was 108 +/- 44 mm (range 22.2 to 200 mm) and mean reference vessel diameter 4.6 +/- 0.8 mm by quantitative angiography; 71% of the lesions analyzable by quantitative angiography (QA) had total occlusions. A total of 227 stents were implanted, 224 of which were deployed successfully (98.7%). Mean percentage of diameter stenosis was reduced from 90.9 +/- 15.5 % (range 41.3 to 100) to 19.0 +/- 8.4% (range 2.3 to 41.5). Device and procedural success were 83.6% each whereas technical success reached 100%. Sixteen lesions had a > or = 30% residual stenosis post-procedure, 6 of them (37.5%) rated as being calcified. Eleven patients experienced major complications (9.1%) and 6 patients experienced minor complications (5%) within 30 days. Duplex ultrasound based 1-month restenosis rate was 9.3%. Target lesion revascularization (TLR) and target vessel revascularization (TVR) rates were 0.8% and 1.7%, respectively and amputation rate was 0.8%. Mean ankle-brachial index (ABI) at rest and after exercise increased significantly from baseline to 30 days follow-up by 0.63 +/- 0.20 to 0.94 +/- 0.17 and from 0.44 +/- 0.23 to 0.85 +/- 0.21, respectively (P<0.001 each).. The treatment of TASC B and C femoro-popliteal lesions with use of the ABSOLUTE stent is safe and feasible. Short-term follow-up documents persistent improvement of hemodynamics. The 6- and 12-month data have to be awaited for further conclusions:

Topics: Acute Disease; Adult; Aged; Aged, 80 and over; Alloys; Angiography; Arterial Occlusive Diseases; Confidence Intervals; Europe; Female; Femoral Artery; Humans; Male; Middle Aged; Popliteal Artery; Postoperative Complications; Prospective Studies; Prosthesis Design; Stents; Treatment Outcome

Topics: Alloys; Angioplasty, Balloon; Arterial Occlusive Diseases; Calcinosis; Equipment Design; Femoral Artery; Humans; Male; Middle Aged; Prosthesis Design; Radiography, Interventional; Stents; Treatment Outcome

Stent fracture has emerged as a new problem in the percutaneous transluminal angioplasty of the superficial femoral artery (SFA). The aim of our study was to delineate the factors influencing nitinol stent fracture in the SFA. Forty consecutive patients with peripheral artery disease who underwent rescue stenting with a nitinol stent (Luminexx, Bard) in the SFA were enrolled between May 2004 and January 2005. Follow-up angiography was performed 13.6+/-1.0 months later to detect stent fracture. Stent fracture occurred in 11 patients (28%). Lesion length>100 mm, the number of stents used, the lesion involving the distal SFA, chronic total occlusion, and walking>5,000 steps per day were more frequently observed in those with stent fracture than in those without fracture. Of these variables, walking>5,000 steps per day was the strongest independent determinant associated with stent fracture by discriminant analysis (p=0.0027). Vigorous exercise adversely affects stent fracture in patients implanted with a nitinol stent in the SFA.

Topics: Aged; Alloys; Angiography; Arterial Occlusive Diseases; Blood Vessel Prosthesis Implantation; Exercise; Female; Femoral Artery; Follow-Up Studies; Graft Occlusion, Vascular; Humans; Male; Prosthesis Failure; Retrospective Studies; Risk Factors; Stents; Walking

Clinical results following stent implantation in the superficial femoral artery (SFA) are limited due to restenosis, often caused by stent fractures. Therefore new stent devices are desirable. The present study details our initial experience with the routine use of the novel Protégé EverFlex long self-expanding nitinol stent for treatment of long SFA total occlusions or stenoses.. Between February and March 2006 a total of 15 EverFlex nitinol stents were implanted in 12 patients with either total SFA occlusions (n = 9) or long stenoses (n = 3), mean lesion length 14.9 cm (+/- 10.4 cm). All patients presented with claudication stage Fontaine IIb (Rutherford category 3). Stent lengths were 10 cm (n = 6), 12 cm (n = 1), or 15 cm (n = 8), stent diameters were 6 mm (n = 14) and 7 mm (n = 1). Access was gained either by the crossover (n = 9), antegrade (n = 2), or popliteal approach (n = 1). After predilatation, stent placement and postdilatation were performed with 100% technical success. Clinical and apparative follow-up after 6-8 weeks indicated the absence of restenosis or reocclusion in all cases.. The novel long self-expanding EverFlex nitinol stent (10 cm/12 cm/15 cm in length) exhibits excellent technical handling characteristics with good short-term clinical results. Mid-term and long-term clinical results as well as potential stent fractures need to be further examined.

Topics: Aged; Alloys; Arterial Occlusive Diseases; Female; Femoral Artery; Graft Occlusion, Vascular; Humans; Male; Postoperative Complications; Stents; Treatment Outcome; Vascular Surgical Procedures

Topics: Alloys; Angioplasty, Balloon; Arterial Occlusive Diseases; Blood Vessel Prosthesis Implantation; Femoral Artery; Humans; Polytetrafluoroethylene; Popliteal Artery; Prosthesis Design; Stents; Thrombosis; Treatment Outcome; Vascular Patency

Topics: Aged; Aged, 80 and over; Alloys; Angioplasty, Balloon, Coronary; Arterial Occlusive Diseases; Blood Vessel Prosthesis Implantation; Combined Modality Therapy; Femoral Artery; Graft Occlusion, Vascular; Heparin; Humans; Male; Popliteal Artery; Radiography; Reoperation; Stents; Thrombolytic Therapy

The aim of this study was to investigate the occurrence and the clinical impact of stent fractures after femoropopliteal stenting.. The development of femoral stent fractures has recently been described; however, there are no data about the frequency and the clinical relevance.. A systematic X-ray screening for stent fractures was performed in 93 patients. In total, 121 legs treated by implantation of self-expanding nitinol stents were investigated after a mean follow-up time of 10.7 months. The mean length of the stented segment was 15.7 cm.. Overall, stent fractures were detected in 45 of 121 treated legs (37.2%). In a stent-based analysis, 64 of 261 stents (24.5%) showed fractures, which were classified as minor (single strut fracture) in 31 cases (48.4%), moderate (fracture of >1 strut) in 17 cases (26.6%), and severe (complete separation of stent segments) in 16 cases (25.0%). Fracture rates were 13.2% for stented length < or =8 cm, 42.4% for stented length >8 to 16 cm, and 52.0% for stented length >16 cm. In 21 cases (32.8%) there was a restenosis of >50% diameter reduction at the site of stent fracture. In 22 cases (34.4%) with stent fracture there was a total stent reocclusion. According to Kaplan-Meier estimates, the primary patency rate at 12 months was significantly lower for patients with stent fractures (41.1% vs. 84.3%, p < 0.0001).. There is a considerable risk of stent fractures after long segment femoral artery stenting, which is associated with a higher in-stent restenosis and reocclusion rate.

Topics: Alloys; Arterial Occlusive Diseases; Equipment Failure; Femoral Artery; Follow-Up Studies; Graft Occlusion, Vascular; Humans; Popliteal Artery; Radiography; Severity of Illness Index; Stents; Vascular Patency

To report a retrospective cohort study of nitinol stent implantation in patients at high risk for restenosis owing to long-segment (> or =10 cm) femoropopliteal disease.. Sixty-five consecutive patients with peripheral artery disease underwent long-segment (> or =10 cm) femoropopliteal stent implantation using self-expanding nitinol stents after initial failure of plain balloon angioplasty (i.e., residual stenosis >30% or a flow-limiting dissection). Patients were followed for first occurrence of in-stent restenosis, defined as a >50% lumen diameter reduction by color-coded duplex sonography, with angiographic confirmation.. Cumulative median length of the stented segments was 16 cm (interquartile range [IQR] 12-25, absolute range 10-40) using up to 5 overlapping stents. During the median 8-month follow-up (IQR 6-11), no early thrombotic reocclusions occurred within 30 days, but 26 (40%) patients developed an in-stent restenosis. Cumulative freedom from restenosis at 6 and 12 months was 79% and 54% overall, respectively; at the same time periods, the rates were 84% and 71% in nondiabetic patients (n=41) versus 68% and 22% in diabetics (n=24) (adjusted hazard ratio 3.8, p=0.01). Cumulative stent length and number of implanted stents were not associated with restenosis.. Midterm restenosis after long-segment femoropopliteal stenting using self-expanding nitinol stents remains a major problem, particularly in patients with diabetes mellitus. The midterm results in nondiabetics are encouraging.

Topics: Aged; Alloys; Angioplasty, Balloon; Aortography; Arterial Occlusive Diseases; Cohort Studies; Confidence Intervals; Female; Femoral Artery; Follow-Up Studies; Humans; Ischemia; Leg; Male; Middle Aged; Popliteal Artery; Probability; Proportional Hazards Models; Prosthesis Design; Retrospective Studies; Risk Assessment; Severity of Illness Index; Statistics, Nonparametric; Stents; Treatment Outcome; Vascular Patency

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 identify a new angiographic parameter associated with poor short- and long-term outcomes with nitinol stenting in the larger infrainguinal arteries.. Nitinol stents have proven to be useful and safe, but imperfect, tools for treating claudication and limb-threatening ischemia. Primary and secondary patency in superficial femoral artery (SFA) occlusions treated with nitinol stents are up to 80% at 1 year, but restenosis is between 40-50% at 2 years. The causes of SFA and popliteal restenosis remain unclear. Stent fracture has been implicated in some cases of restenosis, but this is clearly the minority. Chronic mechanical trauma to the arteries caused by native vessel-stent interaction, intensified by limb motion over time, appears to be a more plausible explanation.. Presented here are 2 cases of restenosis apparently caused by acute and chronic trauma to the native vessel from interaction of the artery with the ends of relatively rigid nitinol stent systems.. The source of some future restenotic and occlusive events are not apparent using routine angiography techniques.. The additional step of an on-table leg bend test at 80-90 degrees will allow the interventionalist to visualize many cases of negative interaction between the native artery and the stents that will occur during routine movement. This allows the operator to potentially avoid stent-induced arterial trauma.

Topics: Aged; Alloys; Angiography, Digital Subtraction; Arterial Occlusive Diseases; Blood Vessel Prosthesis Implantation; Female; Femoral Artery; Graft Occlusion, Vascular; Humans; Popliteal Artery; Prosthesis Failure; Stents; Time Factors; Ultrasonography, Interventional

To determine and compare the rates of in-stent restenosis, late clinical deterioration, and stent fractures in nitinol stents versus Wallstents implanted for suboptimal angioplasty in the superficial femoral artery (SFA).. Interrogation of an angioplasty database identified 286 consecutive patients (178 men; mean age 67+/-10 years, range 44-87) with severe claudication (n=254) or critical limb ischemia (n=32) who had stents implanted after suboptimal angioplasty over a 5-year period. Wallstents with a mean stented lesion length of 107+/-71 mm were implanted in 116 patients, while nitinol stents were used in 170 patients: 45 SMART stents (mean stented lesion length 139+/-88 mm) and 125 Dynalink/Absolute stents (mean stented lesion length 125+/-84 mm). Patients were followed for in-stent restenosis (>50%) by duplex ultrasound, clinical deterioration by at least 1 Fontaine stage compared to baseline, and stent fractures by biplanar radiography.. In-stent restenosis rates at 1, 2, and 3 years were 46%, 66%, and 72% for Wallstents compared to 20%, 36%, and 53% for nitinol stents (p<0.001), respectively, without significant difference between the 2 nitinol stent groups (p=0.59). Clinical deterioration at 1, 2, and 3 years was found in 10%, 15%, and 18% with Wallstents versus 4%, 5%, and 5% with nitinol stents (p=0.014), respectively, without difference between the 2 nitinol stent groups (p=0.47). Fracture rates were 19% for Wallstents after a mean 43+/-24 months, 28% for SMART stents after mean 32+/-16 months, and 2% for Dynalink/Absolute stents after a mean 15+/-9 months.. Intermediate-term in-stent restenosis remains a major problem even with current nitinol stent technology; however, clinical deterioration seems no matter of serious concern with SMART and Dynalink/Absolute stents. Stent fractures may be lower with Dynalink/Absolute stents, but randomized head-to-head comparisons are needed to validate these data.

Topics: Adult; Aged; Aged, 80 and over; Alloys; Angioplasty, Balloon; Arterial Occlusive Diseases; Blood Vessel Prosthesis Implantation; Female; Femoral Artery; Humans; Leg; Male; Middle Aged; Peripheral Vascular Diseases; Prosthesis Failure; Recurrence; Stents; Treatment Outcome; Ultrasonography, Doppler, Duplex; Vascular Patency

Topics: Alloys; Angioplasty; Arterial Occlusive Diseases; Femoral Artery; Germany; Humans; Prosthesis Design; Retrospective Studies; Stents; Treatment Outcome; Vascular Patency

Nitinol slotted tube stents are of great potential benefit in superficial femoral artery (SFA) interventions due to their elastic properties. However, a paucity of data exists for their efficacy in total SFA occlusions.. Using the Cleveland Clinic Foundation Peripheral Database, we identified 40 consecutive patients who underwent percutaneous revascularization for chronically occluded SFA and addressed the outcome stratifying for stent use. We evaluated the reduction in the pressure gradient across the lesion and the need for medication following revascularization.. Of the 40 patients, 26 underwent balloon angioplasty alone and 14 received nitinol slotted tube stents. Patients were well matched for age and cardiovascular risk factors. Similarly, there were no differences in baseline ankle brachial index or claudication class between the groups. Compared to angioplasty alone, stenting was associated with a greater reduction in translesional pressure gradient (72 mmHg versus 32 mmHg; p = 0.002). In addition, patients treated with stents were less likely to require post-procedure adjunctive medical treatment (7.1% versus 42.6%; p = 0.03).. In SFA occlusion, stenting results in greater reduction in translesional pressure gradient and reduced need for adjunctive medical treatment.

Topics: Aged; Aged, 80 and over; Alloys; Angioplasty, Balloon; Arterial Occlusive Diseases; Female; Femoral Artery; Humans; Male; Middle Aged; Stents

The results of infra-inguinal intervention for atherosclerotic occlusive disease have not changed dramatically in the last 15 years despite the advent of many different designs of uncovered stents. "Plain old balloon angioplasty" remains the treatment of choice for short lesions (<3 cm) with good morphologic characteristics. Stents have improved suboptimal angioplasty results somewhat, but results in longer lesions >5 cm have remained poor in most series. Although there are no endografts currently approved for arterial use by the FDA, expanded polytetraflouroethylene (ePTFE) covered endoprostheses are available and their use in the femoropopliteal arteries can dramatically improve the results of endovascular treatment for longer lesions and allow one to treat vascular ruptures and aneurysms. In this article, we will review the published results for the use of endografts in the femoropopliteal arteries and describe what we believe to be the current indications for their use.

Topics: Alloys; Aneurysm; Angioplasty, Balloon; Arterial Occlusive Diseases; Embolism; Femoral Artery; Humans; Polytetrafluoroethylene; Popliteal Artery; Radiography; Stents; Vascular Patency

To report our experience using a commercially available catheter-based system equipped with an intravascular ultrasound (IVUS) transducer to achieve controlled true lumen re-entry in patients undergoing subintimal angioplasty for chronic total occlusions (CTO) or aortic dissections.. During an 8-month period, 10 patients (6 men; mean age 73.4 years) with lower extremity (LE) ischemia from CTOs (n=7) or true lumen collapse from aortic dissections (n=3) were treated. Subintimal access and controlled re-entry of the CTOs were performed with a commercially available 6.2-F dual-lumen catheter, which contained an integrated 64-element phased-array IVUS transducer and a deployable 24-G needle through which a guidewire was passed once the target lumen was reached. The occluded segments were balloon dilated; self-expanding nitinol stents were deployed. In the aortic dissections, fenestrations were performed using the same device, with the IVUS unit acting as the guide. The fenestrations were balloon dilated and stented to support the true lumen.. Time to effective re-entry ranged from 6 to 10 minutes (mean 7) in the CTOs; antegrade flow was restored in all 7 CTOs, and the patients were free of ischemic symptoms at up to 8-month follow-up. In the aortic dissection cases, the fenestrations equalized pressures between the lumens and restored flow into the compromised vessels. There were no complications related to the use of this device in any of the 10 patients.. Our preliminary results demonstrate the feasibility of using this catheter-based system for subintimal recanalization with controlled re-entry in CTOs and for aortic flap fenestrations in aortic dissections. This approach can improve the technical success rate, reduce the time of the procedure, and minimize potential complications.

Topics: Aged; Aged, 80 and over; Alloys; Angioplasty, Balloon; Aortic Aneurysm, Abdominal; Aortic Dissection; Arterial Occlusive Diseases; Cost Savings; Female; Humans; Ischemia; Leg; Male; Middle Aged; Stents; Transducers; Treatment Outcome; Tunica Intima; Ultrasonography, Interventional

Optimalization and improvement in stent material, stent design and deployment may alleviate the problem of restenosis after stenting. The Biflex stent is a novel-design stent made of nitinol; the vascular response after deployment in rabbit iliac arteries was evaluated.. Normocholesterolemic New Zealand white rabbits (n = 8) were used. Iliac arteries were randomized to receive either a stainless steel control stent or a nitinol stent and rabbits were euthanized at 30 days after implantation. All animals survived and there were no adverse events. Vessels were harvested and prepared for histopathologic analysis and histomorphometry. Stents were well opposed to the vessel wall and thrombi were absent. The lumen area and the area within the internal elastic lamina were significantly larger in the nitinol stent group as opposed to the control group (3.8 +/- 0.1 vs 3.3 +/- 0.1 mm, p = 0.009 and 4.6 +/- 0.1 vs 4.1 +/- 0.2 mm, p = 0.03, respectively). There were no differences in injury score, neointimal area, medial area, area within the external elastic lamina and amount of inflammatory cells. Staining for alpha-smooth muscle cell actin and endothelium did not show any differences between the two groups as assessed semiquantitatively.. This nitinol stent with a novel design demonstrated acceptable biocompatibility in iliac arteries of normocholesterolemic rabbits with minimal foreign-body reaction and minimal neointimal formation.

Topics: Alloys; Animals; Arterial Occlusive Diseases; Biocompatible Materials; Equipment Design; Iliac Artery; Male; Rabbits; Stainless Steel; Stents

To evaluate, in a propensity score-adjusted analysis, the intermediate-term primary patency rates associated with nitinol versus stainless steel self-expanding stent placement for treatment of atherosclerotic lesions in femoropopliteal arteries.. The authors analyzed the clinical and imaging data of 175 consecutive patients with peripheral artery disease and either intermittent claudication (n = 150) or critical limb ischemia (n = 25) who underwent femoropopliteal artery implantation of nitinol (n = 104) or stainless steel (n = 123) stents in a nonrandomized setting. The stents were placed owing to either significant residual stenosis (ie, >30% lumen diameter reduction) or flow-limiting dissection after initial balloon angioplasty of the femoropopliteal artery. Patients were followed up for a median period of 9 months (mean, 13 months; range, 6-66 months) for the detection of a first in-stent restenosis, defined as a greater than 50% lumen diameter reduction that was seen at color-coded duplex ultrasonography and confirmed at angiography.. Cumulative patency rates at 6, 12, and 24 months were 85%, 75%, and 69%, respectively, after nitinol stent placement versus 78%, 54%, and 34%, respectively, after stainless steel stent placement (P =.008, log-rank test). There were no statistically significant differences in associated patency among the three different nitinol stents used (P =.72, log-rank test). Multivariate Cox proportional hazard analysis, in which the effect of propensity to receive a nitinol stent was considered, revealed a significantly reduced risk of restenosis with the nitinol stents compared with the risk of restenosis with the stainless steel stents (adjusted hazard ratio, 0.44; 95% confidence interval: 0.22, 0.85; P =.014).. Nitinol stents are associated with significantly improved primary patency rates in femoropopliteal arteries compared with stainless steel stents. Randomized controlled trials are needed to confirm these results.

Topics: Aged; Alloys; Arterial Occlusive Diseases; Arteriosclerosis; Female; Femoral Artery; Follow-Up Studies; Graft Occlusion, Vascular; Humans; Ischemia; Leg; Male; Middle Aged; Popliteal Artery; Prosthesis Design; Prosthesis Failure; Retrospective Studies; Stainless Steel; Stents; Ultrasonography, Doppler, Color; Vascular Patency

Topics: Alloys; Angioplasty, Balloon; Arterial Occlusive Diseases; Blood Vessel Prosthesis Implantation; Coated Materials, Biocompatible; Combined Modality Therapy; Femoral Artery; Humans; Stents

Nitinol slotted tube stents are of great potential benefit in superficial femoral artery (SFA) interventions due to their elastic properties. However, a paucity of data exists for their efficacy in total SFA occlusions.. Using the Cleveland Clinic Foundation Peripheral Database, we identified 40 consecutive patients who underwent percutaneous revascularization for chronically occluded SFA and addressed the outcome stratifying for stent use. We evaluated the reduction in the pressure gradient across the lesion and the need for medication following revascularization.. Of the 40 patients, twenty-six underwent balloon angioplasty alone and 14 received nitinol slotted tube stents. Patients were well matched for age and cardiovascular risk factors. Similarly, there were no differences in baseline ankle brachial index (ABI) or claudication class between the groups. Compared to angioplasty alone, stenting was associated with a greater reduction in translesional pressure gradient (72 mmHg versus 32 mmHg; p = 0.002). In addition, patients treated with stents were less likely to require post-procedure adjunctive medical treatment (7.1% versus 42.6%; p = 0.03).. In SFA occlusion, stenting results in greater reduction in translesional pressure gradient and reduced need for adjunctive medical treatment.

Topics: Aged; Aged, 80 and over; Alloys; Angioplasty, Balloon; Arterial Occlusive Diseases; Blood Vessel Prosthesis Implantation; Coated Materials, Biocompatible; Combined Modality Therapy; Femoral Artery; Follow-Up Studies; Humans; Middle Aged; Ohio; Stents; Treatment Outcome

To investigate a new method of stent deployment using commercially available self-expanding stents to treat bifurcation lesions, providing complete lesion coverage without obstructing branches.. After preliminary in vitro and clinical testing with biliary obstructions, 11 vascular obstructive lesions in 10 patients (7 men; mean age 63 years, range 32-81) were treated by percutaneous Y-shaped stenting. Five patients had iliac arterial stenoses involving the iliac bifurcation; the other 5 patients had 6 central venous obstructions involving branch points. Bifurcated stents were constructed in situ by deploying a nitinol stent extending into one branch and selective balloon fracturing of struts to create a fenestration. A second stent was deployed through the hole, followed by symmetrical fracturing of struts in the second stent to form a Y-shaped configuration.. All deployments were technically successful and resulted in complete coverage of the bifurcation lesions. Protrusion of fractured stent material into flow lumens was minor as determined by angiography, intravascular ultrasound, and passage of balloons, but it required the stents to be oversized. The lengths and luminal diameters were tailored for each arm of the Y-shaped stents.. In situ creation of a Y-shaped stent using 2 self-expanding nitinol stents is a feasible option with potential advantages in the treatment of obstructive lesions involving a bifurcation.

Topics: Adult; Aged; Aged, 80 and over; Alloys; Arterial Occlusive Diseases; Blood Vessel Prosthesis Implantation; Female; Humans; Male; Middle Aged; Peripheral Vascular Diseases; Prosthesis Design; Stents; Treatment Outcome

To retrospectively evaluate the performance of a new self-expanding nitinol stent in the treatment of lower limb arterial occlusive lesions.. The Sinus stent is a flexible, laser-cut device with good radiopacity and radial strength, allowing precise placement via a 7-F introducer, even in tortuous arteries. Over a 3.5-year period, 315 patients (254 men; mean age 64.9+/-10.8 years, range 39-93) had 403 lower limb lesions treated: 172 iliac (132 stenoses, 40 occlusions), 204 femoral (131 stenoses, 73 occlusions), and 27 popliteal (19 stenoses, 8 occlusions). The majority of patients (272, 86%) were in stage IIb of Fontaine's classification, 31 (10%) in stage III, and 12 (4%) in stage IV. Mean lesion lengths were iliac: 51.9+/-32.1 mm, femoral: 66.3+/-51.5 mm, and popliteal: 44.3+/-27.2 mm. Indications for stenting were 222 postdilation residual stenoses, 125 dissections, and 35 restenoses; 21 lesions were directly stented.. Immediate technical success was 100%. Clinical success was 98%. The ankle-brachial index increased from 0.62+/-0.12 to 0.91+/-0.14. In 64 lesions, there were 3 early thromboses. Mean follow-up was 16.1+/-9.7 months (range to 40). There were 79 restenotic episodes: 14 iliac, 56 femoral, and 9 popliteal. Primary and secondary patencies for all lesions at 3 years were 72.5%+/-6.6% and 81.8%+/-5.9%, respectively. Stenoses demonstrated better patency than occlusions (primary: 78.0%+/-7.3% versus 60.2%+/-7.1%, p<0.001; secondary: 86.8%+/-6.1% versus 71.3%+/-6.7%, p<0.001). Men had better secondary patency at 3 years (83.7% versus 73.4%, p<0.05). For femoral lesions >8 cm, the results were acceptable for stenoses (66.7% primary and secondary patency at 3 years), but for lengthy occlusions, the restenosis rate was high (50.0% for occlusions versus 25.0% for stenoses, p<0.05).. Angioplasty with the Sinus stent seems safe and effective in the treatment of peripheral arterial occlusive diseases, giving excellent results at the iliac and common femoral artery levels. Treatment results are better for stenoses than for occlusions. An occlusion length

Topics: Adult; Aged; Aged, 80 and over; Alloys; Angioplasty, Balloon; Arterial Occlusive Diseases; Female; Humans; Leg; Male; Middle Aged; Peripheral Vascular Diseases; Prosthesis Design; Retrospective Studies; Risk Factors; Statistics, Nonparametric; Stents; Survival Analysis; Treatment Outcome

To evaluate the performance and identify predictors of outcome after the use of self-expanding nitinol stents in the treatment of femoropopliteal arterial occlusive disease.. A retrospective analysis of a prospectively collected database was performed. Outcomes of patients who underwent placement of a nitinol stent in the femoral or above-knee popliteal arteries between 1999 and 2002 were studied. Patency, limb salvage, and patient survival were determined by Kaplan-Meier estimation and intergroup comparisons by log-rank test and Cox proportional hazards model. To define individual factors associated with clinical outcomes, stepwise regression analysis was performed.. A total of 41 patients (mean age, 70 +/- 10 years; gender, 26 men and 15 women) underwent percutaneous placement of nitinol stents. Limb salvage was the indication for intervention in 68% of patients. Diabetes was present in 54%, and 36% had end-stage renal disease. Nitinol stents were placed in the superficial femoral (35 patients) or the above-knee popliteal (6 patients) arteries. The mean postprocedural increase in ankle-brachial index was 0.32 +/- 0.19. The 6-month, 1-year, and 2-year primary patency and limb-salvage rates were 95%, 84%, and 84%, and 92%, 89%, and 89%, respectively. Major amputations occurred only in patients undergoing limb-salvage procedures presenting with major tissue loss. No statistically significant differences in patency were seen with regard to diabetes, end-stage renal disease, runoff score, length of vessel stented (median, 80 mm), hypertension, or smoking.. Our initial experience with self-expanding nitinol stents for femoropopliteal occlusive disease appears to demonstrate acceptable patency and limb-salvage rates at these early time points. Further evaluation of clinical outcome with these devices in this and larger groups of patients is warranted.

Topics: Aged; Aged, 80 and over; Alloys; Arterial Occlusive Diseases; Blood Vessel Prosthesis Implantation; Female; Femoral Artery; Humans; Male; Middle Aged; Popliteal Artery; Predictive Value of Tests; Retrospective Studies; Stents; Treatment Outcome; Vascular Patency

To report on a prospective two-center study to evaluate safety and effectiveness of a self-expanding nitinol coil stent in patients with femoropopliteal obstructive disease.. The IntraCoil nitinol stent was used in 37 patients (28 men and nine women; mean age, 62.4 y plus minus 10.7; range, 43-81 y) presenting with high-grade stenoses (n = 23) or short (<3 cm) occlusions (n = 17) of the superficial femoral artery (SFA; n = 33) or popliteal artery (n = 4). Indications for stent placement were significant residual stenosis (>30%) or dissection after angioplasty. Follow-up evaluations with measurement of the Doppler ankle-brachial index (ABI), assessment of Rutherford clinical stage, and color-coded duplex sonography were performed at discharge and 1, 3, 6, 12, and 18 months thereafter. Primary endpoints of the study were immediate technical and clinical success and 1-year patency.. Initial technical success was achieved in all patients. In 10 patients (27%), more than one 40-mm-long device had to be implanted for total lesion coverage; in three patients (8.1%), stents were placed in two separate segments of the SFA simultaneously. The total number of stents deployed was 50. Stent placement induced an initial improvement of the ABI from 0.54 plus minus 0.2 to 0.92 plus minus 0.11 (P <.01). Follow-up data for 12 months after treatment are available for 29 of 37 patients (78.4%); mean follow-up is 15.6 months (range, 1-26 mo). Primary patency rates at 6 and 12 months were 97.1% (SE = 2.9) and 86.2% (SE = 6.5). The primary assisted patency rate was 100% at 12 months.. Endovascular placement of the IntraCoil self-expanding nitinol coil stent for salvage of failed angioplasty in patients with femoropopliteal obstructive disease is an effective and safe procedure with promising mid-term results.

Topics: Adult; Aged; Aged, 80 and over; Alloys; Angioplasty, Balloon; Arterial Occlusive Diseases; Constriction, Pathologic; Female; Femoral Artery; Humans; Longitudinal Studies; Male; Middle Aged; Patient Selection; Peripheral Vascular Diseases; Popliteal Artery; Safety; Stents; Treatment Outcome

To evaluate the efficacy, safety and limitation of a new 6F-compatible nitinol stent (Dynalink(TM).. We treated 50 patients (17 women, 33 men, mean age 72 +/- 8 years) by implanting 80 Dynalink(TM)-stents into 75 vessels during a 6-month period. Target lesions were: iliac artery: 25, femoral artery: 31, popliteal artery: 16, femoro-popliteal bypass: 5, subclavian vein: 3. Preinterventional Rutherford classifications: Class 1 : 3 legs (5 %), class 2 : 27 legs (51 %), class 3 : 16 legs (31 %), class 4 : 2 legs (4 %), class 5 : 5 legs (9 %). 40 % stents each were implanted ipsilateral, 60 % cross-over.. All interventions were successful regardless of a sometimes anatomically difficult access to the lesion. The device was characterised by a high flexibility and radial force and the stent did not shorten.. One distal stent dislocation during placement occurred, no puncture site complication. The mean diameter stenosis was reduced from 91 +/- 10 % (75 - 100 %) to 4 +/- 8 % (0 - 30 %). The ankle-brachial index was improved from 0.46 +/- 0.22 to 0.75 +/- 0.23 (p < 0.001). Post-interventional Rutherford classifications: Class 0 : 43 legs (81 %), class 1 : 5 legs (4,5 %), class 5 : 5 legs (4,5 %).. The new 6F-sheath compatible nitinol stent is characterised by a good flexibility, radial force, and a lack of shortening. By the reduction of the diameter of the device to 6F, the potential risk of a local bleeding complication may be reduced and 6F sealing devices will be usable. Disadvantages are the 0.018 inch guide-wire lumen and the limited stent sizes.

Topics: Adult; Aged; Aged, 80 and over; Alloys; Angiography; Angioplasty, Balloon; Arterial Occlusive Diseases; Female; Humans; Leg; Male; Middle Aged; Stents

The self-expanding Polytetrafluoroethylene-lined nitinolstent Hemobahn offers from its design a prophylaxis for re-occlusion after angioplasty of long femoral artery occlusions. During the last two years we placed in 33 patients at 35 extremities a total of 53 Hemobahns. Fontaine's clinical stages were: 30 x IIb, 1 x III and 4 x IV. The treated lesions were femoral stenoses (3x) and occlusions (32x with mean distance 12 cm). Follow-up-visits were after 3, 6 and 12 months. The mean ankle-brachial-index changed from 0.49 to 0.85, post-interventional Fontaine's stages were: 24 x I, 5 x IIa, 2 x IIb and 4 x IV. The primary inhospital patency rate was 91%. After 3 months all primary/secondary patency rates were: 77%/87%, after 6 months 62%/85% and after 1 year 40%/67%. Causes for re-occlusions were a poor "run off", calcifications and multiple vessel lesions. The results for "ideal indications" were much better. Such "ideal indications" applied to: > or = 1 cm "healthy" proximal and distal vascular segments, missing lesions in the popliteal artery, at least one open lower leg vessel and no severe calcifications. The primary/secondary patency rate was inhospital 100% (n = 23), after 3 months 95/100%, after 6 months 85/100% and after 1 year 80/100%. Side effects were local haematoma, pain in the prosthesis and temporarily temperature reactions. Sonographically no re-stenoses at the limb ends were observed. Hemobahn-endoprostheses are suited for therapy of long femoral artery occlusions. The medium patency rate of "ideal indications" is higher than that of angioplasty with or without uncovered stents.

Topics: Aged; Alloys; Angiography, Digital Subtraction; Angioplasty, Balloon; Arterial Occlusive Diseases; Female; Femoral Artery; Follow-Up Studies; Humans; Male; Middle Aged; Prospective Studies; Recurrence; Stents; Time Factors; Ultrasonography, Doppler, Color; Vascular Patency

This experimental study was conducted to evaluate neointimal thickness, lumen diameters, and histologic changes in normal and stenotic porcine iliac arteries following placement of self-expanding nitinol Strecker stents.. Neointimal trauma causing slight vascular stenosis was induced unilaterally within external iliac arteries of 12 swines by means of endothelial abrasion and high cholesterol diet. Nitinol Strecker stents were placed within the stenotic and the normal contralateral vascular segments. For histopathologic evaluation, the pigs were killed 12 or 24 weeks after stent placement and luminal diamters were evaluated angiographically.. Excluding one occlusion, 15% narrowing of the lumen diameter was induced unilaterally (P = .002). Initial luminal gain after stent placement was greater for stenotic than for normal arteries. The amount of neointima thickness was not different between stenotic and normal vessels (P > .05). Comparing vascular diameters before stent placement and at follow-up, luminal loss due to neointima proliferation was 22% within normal arteries (P = .0002), while a luminal gain by 15% was found within the stenotic arteries (P = .008). Maturation of neointima and endothelial coverage were complete after 24 weeks.. Even though nitinol Strecker stents induce excessive neointimal proliferation, stenotic arteries seem to profit from great early luminal gain resulting in 15% of vascular expansion at follow-up while slight stenosis is induced within normal iliac arteries.

Topics: Alloys; Angiography; Animals; Arterial Occlusive Diseases; Blood Vessel Prosthesis Implantation; Disease Models, Animal; Female; Follow-Up Studies; Iliac Artery; Stents; Swine; Treatment Outcome; Tunica Intima

Stenting is increasingly being used to treat carotid artery disease. However, complications including distal embolization, stent thrombosis, stent collapse from external compression, the need for high-pressure inflation with increased neointimal response, or balloon rupture during stent expansion and stent loss are all potential problems and of concern. To address each of these specific concerns, a new stent was designed, which is self-expandable, made of nitinol, with temperature-dependent superelastic properties, and with high vessel wall surface coverage. Since this device has a number of novel characteristics, we aimed to assess the short- and long-term histopathologic response in pig carotid and iliac arteries. Single stents were deployed in pig carotid and iliac arteries after overstretch balloon injury. Angiograms were performed pre- and poststenting and prior to sacrifice. Intravascular ultrasound was used before implantation to determine vessel size. Vessels were examined histologically at 1 month (n = 6) and 6 months (n = 6) for morphometric analysis, hemorrhage and thrombus, endothelialization, and inflammatory and fibrotic responses. There was a 100% angiographic success rate at implantation. In one case, it was determined histologically that a single stent was implanted in a dissection plane of a pig's left iliac artery and was occluded by organized thrombus, with the true lumen being patent. At 6-month follow-up, this was the only evidence of a single stent occlusion, with flow adjacent to the stent in the true lumen. In the other vessels, the stents showed good vessel wall-stent apposition and the lumens were patent with a concentric and thin neointima. Inflammatory cells were rare and there were no mural thrombi. Coverage of the vessel wall by endothelial-like cells was complete at 1 month. The novel nitinol EndoStent appears to have favorable biocompatibility with minimal thrombus deposition or inflammatory response, and its use is feasible for clinical application in carotid and iliac arteries.

Topics: Alloys; Animals; Arterial Occlusive Diseases; Biocompatible Materials; Blood Vessel Prosthesis Implantation; Carotid Arteries; Disease Models, Animal; Follow-Up Studies; Iliac Artery; Prosthesis Design; Stents; Swine

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

The objective of this study was to analyze the primary and long-term results of implanting self-expanding covered nitinol stents (EndoPro I) in iliac arteries.. A total of 48 EndoPro (length 8.3 +/- 4.2 cm) were implanted in 39 patients. In 22 cases (group A) the implantation was performed after excimer laser-assisted recanalization (PTLA) of long iliac occlusions (mean 9.8 +/- 3.9 cm). Other indications were aneurysmatic lesions (n = 16) and one arterial perforation (group B).. In 21 of 22 patients of group A the patency of the blood vessel was successfully restored. In all cases of group B the aneurysmatic lesions were finally excluded. This was correlated with a clinical improvement of at least one grade (Rutherford criteria) in 86.4% of patients (group A). The primary patency rate based on clinical examination (treadmill test) and color-coded Doppler was evaluated at 6 (89.7%), 12 (87.1%), and 24 (84.2%) months follows up, respectively. Subacute thromboses occurred in two, relevant restenoses in three cases (group A). In three of these 5 cases the vessel segment was successfully reopened by PTLA or rt-PA thrombolysis, leading to secondary patency rates of 94.9% at 6 and 92.1% at 12 and 24 months, respectively.. In cases of relevant dissection following PTLA of long pelvic artery occlusions implantation of covered stents is effective to stabilize the results. Furthermore, the device is well applicable to seal arterial ruptures or aneurysms.

Topics: Adult; Aged; Aged, 80 and over; Alloys; Angioplasty, Balloon, Laser-Assisted; Arterial Occlusive Diseases; Follow-Up Studies; Humans; Iliac Aneurysm; Iliac Artery; Middle Aged; Polyethylene Terephthalates; Prosthesis Design; Radiography; Stents; Ultrasonography

The purpose of this study was to use intravascular sonography to evaluate neointima formation, plaque location, and the performance of self-expanding nitinol (Memotherm) stents in iliac arteries.. Seventeen patients (mean age, 64+/-9.4 years) with stenoses or occlusions of the common (n = 12) or external (n = 5) iliac artery were treated with 21 Memotherm stents (mean diameter +/- SD, 8.9+/-1.3 mm; mean length, 53+/-20.9 mm). Four patients had two stents each. Intravascular sonography was performed 13+/-6 months after stent implantation. Maximum thickness of neointima and maximum cross-sectional plaque area were measured. Qualitative analysis of plaque composition and lesion topography were also assessed.. Intravascular sonography revealed 22.1%+/-17.3% maximum percentage of restenosis, and maximum plaque area was found to be 11.2+/-10 mm2. Only hypoechogenic in-stent lesions (soft plaques) were found. Seven (33%) incomplete stent expansions and two (10%) incomplete appositions of the stent to the vessel wall were revealed by intravascular sonography.. Iliac artery Memotherm stents generally showed moderate in-stent restenosis with uniform neointima distribution. Incomplete stent expansion was detected in one third of all implanted stents.

Topics: Alloys; Arterial Occlusive Diseases; Female; Humans; Iliac Artery; Male; Middle Aged; Observer Variation; Recurrence; Stents; Tunica Intima; Ultrasonography, Interventional

Evaluation of midterm success and patency rates after placement of Cragg stents in iliac arteries.. During a period of 26 months 16 patients, with a total of 19 iliac lesions were treated percutaneously by placement of 20 stents. Indications of stent placement were iliac occlusion in 4 cases and high-grade iliac stenoses in 15 cases. Indication for stent placement in the stenotic lesions were insufficient results following balloon angioplasty in 11 cases and extensive dissection in 4 cases.. The ankle-brachial index was improved from 0.53 +/- 0.28 to 0.85 +/- 0.26 immediately after the intervention and was 0.80 +/- 0.15 at 16 months follow-up. Cumulative patency rate was 71% after 12 months.. The occlusion and restenosis rates are high. Disadvantages of Cragg stents are low flexibility and a large bore introducer system. The radiopacity of the Cragg stent is advantageous for fluoroscopic positioning.

Topics: Aged; Aged, 80 and over; Alloys; Angiography; Angioplasty, Balloon; Arterial Occlusive Diseases; Evaluation Studies as Topic; Female; Follow-Up Studies; Humans; Iliac Artery; Male; Middle Aged; Stents; Time Factors

To evaluate a new self-expanding nitinol coil stent in stenotic or occluded peripheral arteries.. Seventy-three symptomatic patients (58 men; mean age 67 years) were treated with nitinol stents for lesions in the iliac artery (9 stenoses); superficial femoral artery (SFA) (39 stenoses, 6 occlusions); popliteal artery and tibioperoneal trunk (9 stenoses, 7 occlusions); and 3 bypass grafts. Mean diameter stenosis was 84.4% +/- 9.9% (range 75% to 100%), and mean lesion length was 45 +/- 23 mm (range 20 to 120 mm).. Eighty-eight 40-mm-long stents with diameters between 5 and 8 mm were implanted percutaneously for suboptimal dilation (n = 45); dissection (n = 21); and restenosis (n = 7). All stents but one were implanted successfully; the malpositioned stent was removed, and another stent was successfully deployed. There were 3 (4.1%) failures due to thrombosis at 24 hours. During the mean 16-month follow-up (range to 44 months), 4 restenoses (3 femoral, 1 popliteal) have occurred; 2 were treated with repeat dilation and 2 underwent bypass. Primary and secondary patency rates at 18 months were 87% and 90%, respectively, for all lesions (iliac: 100% for both; femoral: 85% and 88%; popliteal: 87% and 100%).. This new nitinol stent seems to be safe and effective with favorable long-term results, even in distal SFA lesions and popliteal arteries. Its flexibility and resistance to external compression allow its placement in tortuous arteries and near joints.

Topics: Aged; Alloys; Angioplasty, Balloon; Arterial Occlusive Diseases; Constriction, Pathologic; Equipment Design; Evaluation Studies as Topic; Female; Follow-Up Studies; Humans; Life Tables; Male; Peripheral Vascular Diseases; Stents; Time Factors; Treatment Outcome; Vascular Patency

The technical details as well as first clinical results of a newly developed Nitinol stent are presented. The spiral-shaped Nitinol stent was implanted in two patients with complicated peripheral arterial obstruction after bypass surgery. Stent implantation was very exact and technically simple using a special implantation catheter. While one patient is free of symptoms three months after stent implantation, an early obstruction was observed in the other patient one day after the interventional procedure. The specific spiral design allows a simple percutaneous extraction of the stent. A cross-over use of the stent seems principally possible, but limited due to the length of the implantation catheter of 70 cm. Prospective clinical studies are, however, warranted.

Topics: Adult; Alloys; Arterial Occlusive Diseases; Blood Vessel Prosthesis; Femoral Artery; Humans; Male; Middle Aged; Polyethylene Terephthalates; Popliteal Artery; Radiography; Stents

To compare technical aspects and neointima formation of a new Nitinol stent and a Wallstent.. A Nitinol sten and a Wallstent were placed into the iliac arteries of 14 sheep (total of 28 stents) and followed angiographically. Seven sheep were killed after 1 month and 7 after 4.5 months. Examination of histologic specimen by light microscopy was performed to determine neointimal and medial thickness inside the stents. Measurements were analyzed statistically.. Neointima was thicker in Nitinol stents (N) than in Wallstents (W) (P < 0.004), both adjacent to (W = 0.265 mm, N = 0.596 mm) and between the stent wires (W = 0.177 mm, N = 0.361 mm). Because of poor radiopacity and the Crochê releasing technique, delivery was more difficult with Nitinol stents. High-grade stenosis was found in two Nitinol stents at 1 and 4.5 months of follow-up, respectively. One Wallstent was insufficiently incorporated into the vessel wall.. The observed difference in neointima formation that may be caused by differences in design, mechanical properties or the metal alloy of the stents probably is too insignificant to be relevant to patency of large arteries. However, it may be relevant in small vessels such as coronary arteries.

Topics: Alloys; Animals; Arterial Occlusive Diseases; Biomechanical Phenomena; Cobalt; Constriction, Pathologic; Equipment Design; Follow-Up Studies; Iliac Artery; Iron; Radiography; Sheep; Stents; Surface Properties; Tunica Intima; Tunica Media; Vascular Patency

To determine the feasibility of use of a self-expanding nitinol stent covered with polyester fabric in long iliac stenoses.. In 10 patients with 12 iliac artery stenoses (6-10 cm long [mean, 7.5 cm]), a Cragg endoluminal graft was placed percutaneously after failure of percutaneous transluminal angioplasty.. At angiography after implantation of 15 Cragg endoluminal grafts, patency was restored and the dissection flap was eliminated without any residual stenosis in all cases. At 1-13-month follow-up (mean, 7 months), eight patients were asymptomatic, with a mean ankle-brachial index of 0.90 +/- 0.15 (standard deviation). Arterial rupture occurred in one patient, with thrombosis of the artery with the stent within 1 day. In one patient, tight restenosis was seen at the proximal part of the stent. In another patient, moderate restenosis was seen at the distal junction of the prosthesis with the native artery, but restenosis did not occur within the stent. The 6-month primary patency rate of the stent graft was 80%.. In long iliac artery stenoses, the deployment of the Cragg endoluminal graft is feasible and no short-term complications were seen.

Topics: Aged; Alloys; Angioplasty, Balloon; Arterial Occlusive Diseases; Combined Modality Therapy; Constriction, Pathologic; Female; Humans; Iliac Artery; Male; Middle Aged; Radiography, Interventional; Stents; Vascular Patency

The success rate and time taken for recanalization was determined in a prospective study of 82 consecutive unselected patients (53 men, 29 women; mean age 65.7 +/- 13, from 28 to 88 years). There were 106 complete occlusions of infrarenal arteries and a hydrophilic guide wire with a special 5-F recanalization catheter was used. Mean occlusion length was 12.97 +/- 10 cm (from 1 cm-45 cm). 79.3% of occlusions were in the femoro-popliteal territory, 6.6% were iliac and 14.1% tibial. 101 of the 106 occlusions were recanalized (95.3%). Mean recanalization time was 120.8 +/- 228.1 s (from 1 s-1440 s), mean recanalization velocity was 0.11 cm/s. The majority of obstructions could be recanalized in less than one minute. The five occlusions which could not be recanalized were distal lesions in the superficial femoral artery and which were longer than 10 cm; two were calcified. There were no complications resulting from the recanalization apart from three perforations which were clinically not apparent. Consequent angioplasty proved successful in 78.1% of these patients.

Topics: Adult; Aged; Aged, 80 and over; Alloys; Angioplasty, Balloon; Arterial Occlusive Diseases; Female; Femoral Artery; Humans; Iliac Artery; Male; Middle Aged; Popliteal Artery; Prospective Studies; Radiography, Interventional; Tibial Arteries; Time Factors

Clinical application of roentgeno-endovascular++ prosthesis was initiated in March, 1984, following 2-year developments and experimental implantations of endoprostheses made from an alloy with a mould storage effect. An effect of implantation of the endoprosthesis into the arterial wall by covering it with an nonhyperplastic, nonadhesive neointima. In 103 patients, 121 endoprosthesis implantations had been made into the iliac, femoral, and popliteal arteries over 5 years, 76.8% of the patients had had a severe concurrent disease. The age of the patients ranged from 21 to 72 years. Positive results were obtained in 93.7% of all the implantations. The long-term results were studied during 0.5-5.0 years' follow-ups. Poor results were obtained with endoprosthesis of the superficial femoral and popliteal arteries, which was associated with impaired distal limb blood flow. Indications for endoprosthesis were defined. The technique may be used in critical ill patients in whom direct surgical interventions are contraindicated due to concurrent abnormalities. The methods developed make it possible to successfully make endoprosthesis of the great arteries via a transcutaneous puncture access under local anesthesia.

Topics: Adult; Aged; Alloys; Arterial Occlusive Diseases; Blood Vessel Prosthesis; Femoral Artery; Humans; Iliac Artery; Intraoperative Care; Male; Middle Aged; Popliteal Artery; Radiography; Time Factors