ASSESS Study: Evaluation of ABSOLUTE™ Stent System for Occluded Arteries

Inclusion Criteria: * De novo lesion of the superficial femoral artery (SFA) or proximal popliteal artery within the following parameters: * 10 mm distal to the origin of the profunda femoris (= 10 mm from the femoral bifurcation in the SFA) and * 20 mm from the proximal margin of the intercondylar fossa. * Patients must have symptomatic leg ischemia, requiring treatment of the superficial femoral/proximal popliteal vessel * Target vessel reference diameter visually estimated to be \> 4.0 mm and \< 7.0 mm * Target lesion length visually estimated to be \> 40 mm and \< 200 mm * If the patient has a contralateral SFA or contralateral proximal popliteal lesion, this lesion can be treated as a non-target lesion. The time and way of treatment of the non-target lesion will be left up to the discretion of the investigator * At least one-vessel run-off to the foot confirmed by baseline angiography * Patent common iliac artery, common femoral artery and profunda confirmed by baseline angiography. The patent common iliac artery can be obtained during the index procedure by a successful treatment prior to the treatment of the target lesion. Successful treatment being defined as attainment of final residual diameter stenosis of \< 30% without death, stroke, bleeding requiring \> 2 units transfusion, or any other complication which was device or procedure related. * Patient is acceptable candidate for femoral-popliteal artery bypass surgery Exclusion Criteria: * Previous ipsilateral femoro-popliteal or femoro-tibial surgery * Presence of a stent in the target vessel * Prescheduled staged procedures of multiple lesions within the ipsilateral iliac or ipsilateral popliteal arteries within 30 days after the index procedure * Co-existing aneurysmal disease of the abdominal aorta or iliac or popliteal arteries * Acute thrombophlebitis or deep vein thrombus * Any immunosuppressive disorders, groin infection, or acute systemic infection due to any cause or any viral or bacterial infection * Significant gastrointestinal (GI) bleed within the past month that would contraindicate the use of anti-platelet therapy * Hemodynamic instability * Target lesion is restenotic from previous intervention