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

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