Edwards Lifesciences Self-Expanding Stent Peripheral Vascular Disease Study

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.