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

A Prospective, Multicenter, Single Blind, Randomized, Controlled Trial Comparing the Lutonix Catheter vs. Standard Balloon Angioplasty for Treatment of Femoropopliteal Arteries With and Without Stenting.

The purpose of the study is to assess the safety and efficacy of the Lutonix Catheter for treatment of stenosis of the femoropopliteal arteries by direct comparison to standard balloon angioplasty.

The LEVANT I trial will enroll patients presenting with clinical evidence of claudication or critical limb ischemia and an angiographically significant lesion in the femoropopliteal arteries. Patients will be randomized to treatment with either the Lutonix Catheter or standard balloon angioplasty after predilation.

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