Edwards Lifesciences Self-Expanding Stent Peripheral Vascular Disease Study

Study Overview
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Brief Summary
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The main objective of this study is to assess the safety and effectiveness of the Edwards Lifesciences LifeStent nitinol self expandable stent device and its delivery system in the treatment of occlusive superficial femoral artery (SFA) disease by reducing the re-intervention rate as compared to percutaneous transluminal angioplasty (PTA) alone

Detailed Description
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The RESILIENT Trial is a dual stage clinical investigation designed to evaluate the safety and effectiveness of the Edwards Lifesciences self-expanding stent system. Phase 1 consists of a prospective, multi-center, non-randomized study with a peri-procedure endpoint. Phase 2 consists of a prospective, multi-center, randomized study with a 30-day primary safety endpoint and a 6-month primary effectiveness endpoint.

Official Title
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A Randomized Study Comparing the Edwards Self-ExpandIng LifeStent Versus Angioplasty-alone In LEsions INvolving The SFA and/or Proximal Popliteal Arter

Conditions
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Intermittent Claudication, Atherosclerotic Disease, Arterial Occlusive Disease

Intervention / Treatment
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* Other: Percutaneous Transluminal Angioplasty
* Device: LifeStent NT™ Self-Expanding Peripheral Stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent approved by the IRB. ≥ 18 years old. Lifestyle-limiting claudication defined as: Rutherford Cat. 1-3. Target lesion(s) is de-novo or restenotic and located within the native SFA and/or proximal popliteal artery Angiographic evidence of ≥ 50% stenosis or occlusion Target RVD is ≥ 4.0 mm and ≤ 7.0 mm Target total length of the lesion or series of lesions is ≤ 150 mm. Angiographic evidence of at least one vessel runoff to the foot. Exclusion Criteria: Unable to conform to the study protocol procedures and visits. Lifestyle-limiting claudication/CLI (Rutherford Cat. 4-6) Patients who are pregnant or planning to become pregnant during the clinical investigation Contraindication to study related medications, Ni, Ti, Ta, or other media that is not amenable to pretreatment. History of bleeding diatheses or coagulopathy. Concomitant renal failure with a creatinine of > 2.0 mg/dL. Concomitant hepatic insufficiency, thrombophlebitis, uremia, SLE, or DVT at the time of the study procedure. Receiving dialysis or immunosuppressive therapy. Suffered a hemorrhagic stroke ≤ 6 mo prior to the study procedure. Prior peripheral vascular bypass surgery involving the target limb. Target vessel has been previously stented. Target lesion(s) received angioplasty intervention ≤ 6 mo. prior Any non-iliac percutaneous intervention(s) < 7 days prior. Currently participating in an investigational drug/device study. Limited life expectancy of less than two years. Extensive PVD that precludes safe insertion of an sheath. Target lesion(s) is located within an aneurysm or associated with an aneurysm in the vessel segment either proximal or distal to the target lesion(s). Unresolved thrombus within the target vessel. Poor inflow which would not support a vascular bypass graft. Diagnosed with septicemia at the time of the study procedure. Additional percutaneous interventional procedures (cardiac/peripheral) planned ≤ 30 days following procedure.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>PTA Only: Active Comparator Percutaneous transluminal angioplasty (PTA) alone | Other: Percutaneous Transluminal Angioplasty<br>* Balloon Angioplasty<br>|
| Experimental: 2<br>Test Arm: Experimental The main objective of this study is to assess the safety and effectiveness of the Edwards Lifesciences LifeStent nitinol self expandable stent device and its delivery system in the treatment of occlusive superficial femoral artery (SFA) disease. | Device: LifeStent NT™ Self-Expanding Peripheral Stent<br>* Balloon angioplasty plus stent<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: Freedom from death at 30 days post-procedure. Effectiveness: Freedom from Target Lesion Revascularization (TLR) and/or Target Vessel Revascularization (TVR) at 6 months post-procedure. |  | 30 Day, 6 Month, and 12 Month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: Freedom from death, stroke, myocardial infarction, emergent surgical revascularization, significant distal embolization in target limb, and thrombosis of target vessel at 30-days post-procedure. Freedom from 30-day death and 6-month |  | 30 Day, 6 Month and12 Month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SFA, Edwards, Popliteal, LifeStent, PTA, Nitinol