LEVANT I, The Lutonix Paclitaxel-Coated Balloon for the Prevention of Femoropopliteal Restenosis

Inclusion Criteria: Clinical Criteria * Male or non-pregnant female ≥18 years of age. * Rutherford Clinical Category 2-5 * Patient is willing to provide informed consent and comply with the required follow up visits, testing schedule, and medication regimen Angiographic Criteria * A single de novo or restenotic atherosclerotic lesion \>70% in the SFA or popliteal artery that is ≥4 cm and ≤15 cm in total length. * Reference vessel diameter ≥4 mm and ≤ 6mm * Successful wire crossing of lesion * A patent inflow artery free from significant lesion (\>50% stenosis) as confirmed by angiography (treatment of target lesion acceptable after successful treatment of inflow artery lesions) Exclusion Criteria: * Pregnant or planning on becoming pregnant in \< 2yrs * Live expectancy of \<2 years * Patient actively participating in another investigational device or drug study * History of hemorrhagic stroke within 3 months * Previous or planned surgical or interventional procedure within 30 days of index procedure * Chronic renal insufficiency with creatinine \>2.5 mg/L * Prior surgery of the target lesion * Inability to take required study medications * Anticipated use of IIb/IIIa inhibitor prior to randomization * Lesion length is \<4 cm or \>15 cm or there is no normal proximal arterial segment in which duplex ultrasound velocity ratios can be measured * Known inadequate distal outflow * Significant inflow disease * Acute or sub-acute thrombus in target vessel * Severe lesion calcification * Acute vessel occlusion or sudden symptom onset * Use of adjunctive therapies (i.e. laser, atherectomy, cryoplasty, scoring/cutting balloon, etc.) * Prior participation in the current study