Evaluation of Paclitaxel Eluting Stent vs Paclitaxel Eluting Balloon Treating Peripheral Artery Disease of the Femoral Artery

Inclusion Criteria: * Subject age ≥ 18 * Subject has been informed of the nature of the study, agrees to participate, and has signed a Medical Ethics Committee approved consent form. * Subject understands the duration of the study, agrees to attend follow-up visits, and agrees to complete the required testing. * Rutherford category 2-5. * Subject has a de novo or restenotic lesion with ≥ 70% stenosis documented angiographically and no prior stent in the target lesion. * Target lesion is at least 1cm below the origin of the profunda femoris and does not exceed the medial femoral epicondyle. * A single target lesion (stenotic areas separated by more than 3 cm with ≤ 30% stenosis might, at the decision of the investigator, be considered as 2 lesions). * Reference vessel diameter (RVD) ≥ 4 mm and ≤ 6.5 mm by visual assessment. * Patency of at least one (1) infrapopliteal artery to the ankle (\< 50% diameter stenosis) in continuity with the native femoropopliteal artery. * A guidewire has successfully traversed the target treatment segment. Exclusion Criteria: Clinical exclusion criteria * Inability to obtain informed consent. * Life expectancy \< 12 months. * Pregnancy, suspected pregnancy, or breastfeeding during study period (patients of childbearing potential must have negative serum pregnancy test 7 days prior to treatment). * Presence of one or more of the following co-morbid factors: hemodialysis dependence, renal insufficiency with a serum creatinine ≥ 2.5 mg/dl, cerebrovascular accident (CVA) within 1 month of procedure or any CVA resulting in unresolved walking impairment, and/or myocardial infarction (MI) within 1 month of procedure. * Any evidence of hemodynamic instability prior to procedure/randomization. * Coagulopathy or clotting disorders. * Present or suspected systemic infection or osteomyelitis affecting target limb. * Contraindication to contrast media or any study-required medication (antiplatelets, anticoagulants, thrombolytics, etc). * Hypersensitivity to nitinol and/or paclitaxel. * Enrollment into another study. * Intervention of the target lesion less than 90 days prior of the study procedure. Anatomic Exclusion Criteria: * Untreated external iliac artery inflow lesion (study allows for successful treatment prior to study treatment procedures). * Total occlusion uncrossable by a conventional guidewire. * Acute occlusive intraluminal thrombosis of the proposed lesion site. * Evidence of an aneurysm at the target lesion site. * Perforation in the target vessel as evidenced by the extravasation of contrast.