Edwards Lifesciences Self-Expanding Stent Peripheral Vascular Disease Study

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.