Effects of atherectomy on major adverse limb events for femoropopliteal interventions: Vascular Quality Initiative registry.

BACKGROUND: Atherectomy use in treatment of femoropopliteal disease has significantly increased despite scant evidence of benefit to long-term clinical outcomes. AIMS: We investigated the clinical benefits of atherectomy over standard treatment for femoropopliteal interventions. METHODS: Using data from the Society of Vascular Surgery's Vascular Quality Initiative (VQI) registry, we identified patients who underwent isolated femoropopliteal interventions for occlusive disease. We compared 13,423 patients treated with atherectomy with 47,371 receiving standard treatment; both groups were allowed definitive treatment with a drug-coated balloon or stenting. The primary endpoint was major adverse limb events (MALEs), which is a composite of target vessel re-occlusion, ipsilateral major amputation, and target vessel revascularization. RESULTS: Mean age was 69 ± 11 years, and patients were followed for a median of 30 months. Overall rates of complications were slightly higher in the atherectomy group than the standard treatment group (6.2% vs. 5.9%, p < 0.0001). In multivariable analysis, after adjusting for demographic and clinical covariates, atherectomy use was associated with a 13% reduction in risk of MALEs (adjusted odds ratio [aOR]: 0.87; 95% confidence interval [CI]: 0.77-0.98). Rates of major and minor amputations were significantly lower in the atherectomy group (3.2% vs. 4.6% and 3.3% vs. 4.3%, respectively, both p < 0.001), primarily driven by a significantly decreased risk of major amputations (aOR 0.69; 95% CI: 0.52-0.91). There were no differences in 30-day mortality, primary patency, and target vessel revascularization between the atherectomy and standard treatment groups. CONCLUSIONS: In adults undergoing femoropopliteal interventions, the use of atherectomy was associated with a reduction in MALEs compared with standard treatment.

The Vascular Quality Initiative assessment of the Bard Lifestent for the treatment of popliteal artery occlusive disease.

OBJECTIVE: The Bard LifeStent self-expanding stent is approved for the treatment of occlusive disease involving the superficial femoral artery and proximal popliteal artery. We conducted a post-market trial of treatment of the popliteal artery above and below the knee (P1, P2, and P3 segments) within the Society for Vascular Surgery Vascular Quality Initiative (VQI) Peripheral Vascular Intervention registry. METHODS: A single-arm, prospective trial was conducted at 29 VQI sites in the United States, enrolling 74 patients from November 2016 to May 2019. The primary safety outcome was freedom from major adverse events including device-/procedure-related mortality and major amputation at 1 year. The primary efficacy outcomes were freedom from target vessel revascularization and freedom from target lesion revascularization at 1 year. Secondary outcomes included lesion success; procedural success; primary, primary-assisted, and secondary patency; and sustained clinical (improvement in Rutherford class) and hemodynamic success (increase in ankle brachial index >0.10). Outcomes were assessed by Kaplan-Meier analysis. Arteriogram of patients undergoing target lesion revascularization were assessed for stent fracture by a core laboratory. RESULTS: The mean age was 71 years, with 63.5% male and 55% with diabetes. The indication was claudication 28% and chronic limb-threatening ischemia in 72%. The superficial femoral artery-popliteal artery was stented in 38% and the popliteal artery alone in 62%. The majority of stents were placed in the P1 + P2 (39%) or P1 + P2 + P3 (37%) segments of the popliteal artery. The composite primary endpoint of freedom from major adverse events was 82% and 74% at 1 and 2 years, respectively. Freedom from mortality was 100% and 97%, and freedom from major amputation was 100% and 90% at 1 and 12 months, with all deaths and major amputations occurring in patients with chronic limb-threatening ischemia. freedom from target lesion revascularization was 86%, and freedom from target vessel revascularization was 84% at 12 months. At discharge, lesion treatment success was 99%, and procedural success was 82%. Primary patency was 80% and 72%, primary-assisted patency was 80% and 72%, and secondary patency was 89% and 82% at 12 and 24 months. Sustained clinical success was 98% and 95%, and sustained hemodynamic success was 100% and 79% at 12 and 24 months. CONCLUSIONS: In this multi-center, registry-based, single-arm prospective study the Bard LifeStent self-expanding stent demonstrated favorable performance in the challenging anatomy of the P2 and P3 popliteal segment. Post-market studies for label expansion of peripheral vascular intervention devices can be successfully conducted within the Society for Vascular Surgery VQI registry.

Left subclavian artery pseudoaneurysm after blunt chest trauma with left upper extremity ischemia.

We describe a 74-year-old male with delayed onset of acute left upper extremity ischemia after blunt chest trauma with left clavicular fracture, resulting in left subclavian artery injury, including pseudoaneurysm formation, intramural hematoma, thrombosis, and distal embolization to the brachial artery. The patient presented with left upper extremity pain, forearm and hand numbness, and digital cyanosis. The patient was treated with a hybrid approach, consisting of transfemoral percutaneous deployment of a covered stent in the left subclavian artery and concomitant surgical thrombectomy of the left brachial artery, resulting in excellent recovery and resolution of symptoms.

Early Thoracic Endovascular Aortic Repair of Uncomplicated Type B Thoracic Aortic Dissection: An Aorta Team Approach.

BACKGROUND: Although uncomplicated Type B aortic dissection (uTBAD) is traditionally treated with optimal medical therapy (OMT) as per guidelines, recent studies, performed primarily in interventional radiology or surgical operating rooms, suggest superiority of thoracic endovascular aortic repair (TEVAR) over OMT due to recent advancements in endovascular technologies. We report a large, single-center, case control study of TEVAR versus OMT in this population, undertaken solely in a cardiac catheterization laboratory (CCL) with a cardiologist and surgeon. We aimed to determine if TEVAR for uTBAD results in better outcomes compared with OMT. METHODS: This was a retrospective chart review of all patients with uTBAD during the last 13 years, with 46 cases (TEVAR group) and 56 controls (OMT group). RESULTS: In the TEVAR group, the procedure duration of 2.5 hours resulted in 100% procedural success for stent placement, with 63% undergoing protective left subclavian artery bypass, 0% mortality or stroke, and a lower readmission rate (1 vs. 2%; p = 0.04 in early TEVAR cases), but a longer length of stay (12.9 vs. 8.5 days: p = 0.006). The risk of all-cause long-term mortality was markedly reduced in the TEVAR group (RR = 0.38; p = 0.01), irrespective of early (<14 days) versus late intervention. On follow-up computed tomography imaging, the false lumen stabilized or decreased in 85% of cases, irrespective of intervention timing. CONCLUSION: TEVAR performed solely in the CCL is safe and effective, with lower all-cause mortality than OMT. These data, in collaboration with previous data on TEVAR in different settings, call for consideration of an update of practice guidelines.

Effectiveness and Safety of Atherectomy versus Plain Balloon Angioplasty for Limb Salvage in Tibioperoneal Arterial Disease.

PURPOSE: To evaluate the effectiveness and safety of atherectomy versus plain balloon angioplasty (POBA) for treatment of critical limb ischemia (CLI) due to tibioperoneal arterial disease (TPAD). MATERIALS AND METHODS: Patients enrolled in the Vascular Quality Initiative registry who had CLI (Rutherford Class 4-6) and underwent atherectomy versus POBA alone for isolated TPAD were retrospectively identified. Of eligible patients, a cohort of 2,908 patients was propensity matched 1:1 by clinical and angiographic characteristics. The atherectomy group comprised 1,454 patients with 2,183 arteries treated, and the POBA group comprised 1,454 patients with 2,141 arteries treated. The primary study endpoint was major ipsilateral limb amputation. Secondary endpoints were minor ipsilateral amputations, any ipsilateral amputation, primary patency, target vessel reintervention (TVR), and wound healing at 12 months. RESULTS: The median follow-up period was 507 days, the mean patient age was 69 years ± 11.7, and the mean occluded length was 6.9 cm ± 6.5. There was a trend toward higher technical success rates with atherectomy than with POBA (92.9% vs 91.0%, respectively; P = .06). The rates of major adverse events during the procedure were not significantly different. The 12-month major amputation rate was similar in the atherectomy and POBA groups (4.5% vs 4.6%, respectively; P = .92; odds ratio, 0.97; 95% CI, 0.68-1.37). There was no difference in 12-month TVR (17.9% vs 17.8%; P = .97) or primary patency (56.4% vs 54.5%; P = .64) between the atherectomy and POBA groups. CONCLUSIONS: In a large national registry, treatment of CLI from TPAD using atherectomy versus POBA showed no significant differences in procedural adverse events, major amputations, TVR, or vessel patency at 12 months.

National trends and variability of atherectomy use for peripheral vascular interventions from 2010 to 2019.

OBJECTIVE: Small, older studies have suggested that the use of atherectomy devices has become common in peripheral vascular interventions (PVIs) despite the paucity of strong clinical guidelines. We analyzed the 10-year trends in the use of atherectomy for PVIs across the United States and identified the main predictors of atherectomy use. METHODS: Using the Vascular Quality Initiative registry, we identified all patients who had undergone endovascular PVIs for occlusive lower extremity arterial disease from 2010 to 2019. Procedures in which an atherectomy device had been used as the primary or secondary device were classified as the atherectomy group. We calculated the frequency of atherectomy use over time and across geographic regions. Using regression modeling, we identified the factors that were independently associated with atherectomy use. RESULTS: A total of 205,377 PVIs had been performed for 152,693 unique patients. During the 10-year period, 16.6% of the PVI procedures had used atherectomy, increasing from 8.5% in 2010 to 19.7% in 2019 (Ptrend < .0001). Across 17 geographic regions, we found a significant difference in the prevalence of atherectomy use, ranging from 8.2% to 29%. The strongest predictor of atherectomy use was performance of PVI in an office setting (odds ratio [OR], 10.08; 95% confidence interval [CI], 9.17-11.09) or ambulatory center (OR, 4.0; 95% CI, 3.65-4.39) vs a hospital setting. The presence of severe (OR, 2.6; 95% CI, 2.4-2.85) or moderate (OR, 1.5; 95% CI, 1.4-1.69) lesion calcification was also predictive of atherectomy use. Other predictive factors included elective status, insurance provider, lesion length, prior PVI, claudication symptoms, and diabetes mellitus. CONCLUSIONS: Atherectomy use in PVI significantly increased from 2010 to 2019. We found wide regional variability in the use of atherectomy that seemed to be driven more strongly by nonclinical factors.

Laser-Assisted Transgraft Embolization: A Technique for the Treatment of Type II Endoleaks.

A transgraft embolization (TGE) technique was performed in a patient to treat a type II endoleak. Using a transfemoral arterial approach, the endograft was punctured using a coronary laser catheter aimed toward the type II endoleak nidus, which was treated with Onyx (Medtronic, Minneapolis, Minnesota). TGE resulted in successful embolization, as demonstrated on 1-year follow-up CT angiography, which showed complete elimination of the type II endoleak and shrinkage of the aneurysmal sac. TGE is an alternative to transarterial embolization, translumbar embolization, and transcaval embolization.

Bivalirudin versus unfractionated heparin during peripheral vascular interventions: A Propensity-matched Study.

OBJECTIVES: This study aimed to compare the association of access site complications and the use of unfractionated heparin versus bivalirudin during subinguinal peripheral vascular intervention. BACKGROUND: Compared to unfractionated heparin, bivalirudin has been associated with fewer bleeding complications in patients undergoing percutaneous coronary intervention but more ischemic events. The safety and efficacy of direct thrombin inhibitors in peripheral vascular interventions is not well defined. METHODS: We compared the incidence of in-hospital access site complications and discharge status among patients in the multicenter, prospective Vascular Quality Initiative registry who underwent peripheral vascular intervention between August 2007 and January 2014 using bivalirudin or unfractionated heparin. Propensity score matching was used to obtain a balanced cohort of 1,524 patients in each treatment group. RESULTS: Patients treated with bivalirudin had a significantly lower incidence of access site hematomas (2.4% vs. 3.9%, P = 0.018), shorter post-procedural hospitalization (1.0 vs. 1.2 days, P < 0.001) and lower rates of discharge to a nursing home or rehabilitation center rather than home (7.61% vs. 9.73%, P = 0.034) when compared with unfractionated heparin-treated patients. The incidence of in-hospital access site occlusion, distal embolization, and mortality did not differ significantly between groups. CONCLUSIONS: Patients who received bivalirudin had lower rates of access site hematoma, shorter length of stay, and improved discharge status compared with unfractionated heparin during hospitalization for peripheral vascular intervention. Randomized comparisons of these agents are needed to confirm these findings. © 2016 Wiley Periodicals, Inc.

Access site complications after peripheral vascular interventions: incidence, predictors, and outcomes.

BACKGROUND: Access site hematomas and pseudoaneurysms are the most frequent complications of peripheral vascular intervention (PVI); however, their incidence and risk factors remain unclear. METHODS AND RESULTS: We retrospectively analyzed data from the multicenter Vascular Quality Initiative on 22 226 patients who underwent 27 048 PVI from August 2007 to May 2013. Primary end points included incidence and predictors of access site complications (ASCs), length of postprocedural hospitalization, discharge status, and 30-day and 1-year mortality. ASC complicated 936 procedures (3.5%). Of these, 74.4% were minor complications, 9.7% were moderate requiring transfusion, 5.4% were moderate requiring thrombin injection, and 10.5% were severe requiring surgery. Predictors of ASC were age >75 years, female sex, white race, no prior PVI, nonfemoral arterial access site, >6-Fr sheath size, thrombolytics, arterial dissection, fluoroscopy time >30 minutes, nonuse of vascular closure device, bedridden preoperative ambulatory status, and urgent indication. Mean hospitalization was longer after procedures complicated by ASC (1.2±1.6 versus 1.9±1.9 days; range, 0-7 days; P=0.002). Severity of ASC correlated with higher rates of discharge to rehabilitation/nursing facilities compared with home discharge. Patients with severe ASC had higher 30-day mortality (6.1% versus 1.4%; P<0.001), and those with moderate ASC requiring transfusion had elevated 1-year mortality (12.1% versus 5.7%; P<0.001). CONCLUSIONS: Several factors independently predict ASC after PVI. Appropriate use of antithrombotic therapies and vascular closure device in patients at increased risk of ASC may improve post-PVI outcomes.

Three-year results of the VIBRANT trial of VIABAHN endoprosthesis versus bare nitinol stent implantation for complex superficial femoral artery occlusive disease.

OBJECTIVE: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Subintimal angioplasty with a true reentry device for treatment of chronic total occlusion of the arteries of the lower extremity.

OBJECTIVE: To report the efficacy and safety of the Outback(®) LTD(®) Re-Entry Catheter in reentering the distal true lumen during percutaneous intentional extraluminal revascularization (PIER). BACKGROUND: Reentry catheters are used to treat chronic, total arterial occlusions of the lower extremities when standard methods of recanalization have failed. Success and complication rates of these catheters in the real world are uncertain and variable. METHODS: A retrospective review of our peripheral catheterization database from January 2004 to September 2009 was undertaken to identify consecutive cases of peripheral chronic total occlusions (CTOs) requiring the use of the Outback reentry catheter. Patient demographics, indication for the procedure, location and extent of occlusion, procedural success, and complications were studied. RESULTS: A total of 51 patients were identified. Of the 51, 28 (54.9%) patients presented with nonhealing ulcer and 22 (43.1%) had lifestyle-limiting claudication. One patient presented with acute limb ischemia. There were 6 (11.8%) patients with common iliac artery occlusion, 2 (3.9%) with external iliac artery occlusion, 1 (1.9%) with common femoral artery occlusion, 35 (68.6%) with superficial femoral artery occlusion, 6 (11.8%) with popliteal artery occlusion, and 1 (1.9%) with tibioperoneal artery occlusion. Median lesion length was 230 mm. Procedural success was achieved in 49 patients (96.1%). There was 1 (1.9%) periprocedural complication. CONCLUSION: Use of Outback(®) LTD(®) Re-Entry Catheter is a safe and valuable option for PIER/subintimal angioplasty and recanalization in patients with symptomatic lower-extremity CTOs. However, long-term patency remains unknown.

Thrombolysis for lower-extremity deep vein thrombosis.

Elimination of the embolic potential of existing thrombus, restoration of unobstructed flow, prevention of further thrombosis, and preservation of venous valve function are the ideal goals of therapy for acute deep vein thrombosis (DVT). Meeting these goals will not only prevent pulmonary embolus, but will also minimize long-term sequelae of venous hypertension and development of postthrombotic syndrome (PTS). Treatment strategies aimed at eliminating or reducing risk of PTS should focus on preserving valvular function and eliminating risk of continued venous obstruction after acute DVT. Thrombolytic agents are an attractive form of early therapy because they have the ability to eliminate obstructive thrombus in the deep veins, and should therefore help provide protection against PTS. Perceived benefits of early and rapid recanalization in preserving valve function have been the basis for lytic therapy to treat acute DVT. Data from the National Venous Registry and subsequent reports on the role of catheter-directed thrombolysis for treatment of acute lower-extremity DVT indicate that the technique is safe and effective in select patients. More recently, implementation of percutaneous mechanical devices designed to quickly remove acute thrombus has had a significant impact on time and cost of catheter-directed thrombolysis procedure. Although the long-term benefits of this form of therapy are not yet completely known, the Venous Registry can serve as a guide to the judicious selection of patients who will most benefit from this aggressive form of therapy.

Comparison of safety and efficacy of bivalirudin versus unfractionated heparin in percutaneous peripheral intervention: a single-center experience.

OBJECTIVES: The aim of this study was to determine the efficacy and safety of bivalirudin versus low-dose unfractionated heparin (UFH) in percutaneous peripheral intervention (PPI). BACKGROUND: Anticoagulation strategies used in PPI are based primarily on studies of percutaneous coronary intervention where higher doses of heparin are used usually in combination with a glycoprotein IIb/IIIa inhibitor. There are no studies comparing bivalirudin alone versus low-dose heparin in PPI. METHODS: Consecutive patients who underwent PPI at our institution were treated with either bivalirudin or low-dose UFH. Patients were assessed prospectively during index hospital stay for procedural success and bleeding complications. Of 236 patients, 111 were dosed with UFH at 50 U/kg (goal activated clotting time of 180 to 240 s), and 125 were dosed with bivalirudin at 0.75-mg/kg/h bolus followed by a 1.75-mg/kg infusion. Procedural success was defined as <20% post-procedure residual stenosis with no flow-limiting dissections or intravascular thrombus formation and major bleeding as intracranial or retroperitoneal hemorrhage or a fall in hemoglobin >or=5 g/dl. Anticoagulation cost analysis was conducted. RESULTS: Procedural success and major bleeding rates were similar with bivalirudin versus heparin (98% vs. 99% and 2.4% vs. 0.9%, respectively). There were no differences in minor bleeding, time to ambulation, and length of hospital stay. The hospital cost for bivalirudin was $547 and <$1.22 for heparin (10,000 U). Two activated clotting time levels cost $4.00. CONCLUSIONS: Low-dose UFH is as effective and safe as bivalirudin when used as an anticoagulation strategy in patients undergoing PPI, and low-dose UFH is less costly than bivalirudin. Larger randomized studies are required to further evaluate these findings.

Primary nitinol stenting for femoropopliteal disease.

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.

Stenting in the femoropopliteal arterial segment.

In the femoropopliteal arterial segment, balloon angioplasty is a recommended treatment strategy for short lesions. Over the past few years, several reports have emerged on the potential role of self-expanding stents for treating longer, more complex disease segments where the patency following balloon angioplasty is notoriously dismal. This paper will attempt to review the emerging role of nitinol stents for treating patients with chronic lower limb ischemia, secondary to severe femoropopliteal arterial disease.

The management of lower extremity wounds complicated by acute arterial insufficiency and ischemia.

Although wound care therapy has made significant advances in the past several years, clinicians encounter dilemmas on a day-to-day basis. One of these dilemmas is managing ischemic wounds. Certain characteristics (ischemic appearance, a history of a lack of healing, physical examination that finds no pulses, or a transcutaneous oxygen evaluation to suggest tissue hypoxia) will identify the wound as hypoxic or related to arterial disease. The clinician faces several decisions: Should an arteriogram be performed? Should an MRI or ABIs be ordered? Is a vascular surgery consult necessary? In response to this area of diagnostic and management conflict, the authors developed an algorithm for the treatment of patients with ischemic wounds. This article addresses the management of wounds primarily caused by peripheral arterial occlusive disease and includes discussion of the initial wound care consult, the factors that identify and classify patients with arterial wounds, and a description of how transcutaneous oximetry is used to evaluate this subgroup of patients. In addition, the concept of the Vascular Center is introduced and explained, including arterial vascular consultation and evaluation, arterial vascular anatomy, and noninvasive vascular studies that are important tools in the Vascular Center, as well as endovascular interventions such as arteriography, angioplasty and arterial stenting. The basics of arterial revascularization, the use of hyperbaric oxygen therapy to manage the patients with ischemic wounds, and outcome data from a case study illustrating the management algorithm utilized at the authors' facility also are presented.

Self-expanding nitinol stents in the femoropopliteal segment: technique and mid-term results.

The purpose of this study was to evaluate the safety and efficacy of self-expanding SMART nitinol stents in patients with chronic limb ischemia (CLI) demonstrating Type B or C TransAtlantic Inter-Society Consensus (TASC) lesions in the femoropopliteal (FP) arterial segment. There were 137 lower limbs in 122 patients with chronic limb ischemia, secondary to TASC A (n = 12) or TASC B,C (n = 125) lesions in the FP artery were treated with Cordis SMART self-expanding nitinol stents. Hemodynamic stent failure occurred with the presence of a greater than 50% stenosis within the stented segment, measured by standard Duplex velocity criteria, obtained at various postintervention intervals. The hemodynamic primary stent patency was calculated by life-table methods from the time of intervention, uninterrupted by hemodynamic stent failure. The mean lesion length was 12.2 cm (range, 4 to 28 cm). The technical success was 98%. Within the follow-up period (mean, 302 days), 24 limbs were diagnosed with hemodynamic stent failure. The hemodynamic primary stent patency rates were 92%, 76%, 66%, and 60% at 6, 12, 18, and 24-months, respectively. These data provide objective evidence that endovascular treatment of FP TASC A, B and C lesions using self-expanding nitinol SMART stents in patients with chronic limb ischemia provides favorable safety and durability outcomes. Further investigation is warranted.