Edwards Lifesciences Self-Expanding Stent Peripheral Vascular Disease Study

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

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

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.

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.