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

Official Title: “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 femropopliteal arteries. Patients will be randomized to treatment with either the Lutonix Catheter or standard balloon angioplasty after predilation.

Intervention(s) in this Clinical Trial

• Device: Lutonix Catheter
  • Paclitaxel Coated Balloon Catheter
• Device: Standard uncoated Balloon Angioplasty Catheter
  • plain, uncoated angioplasty balloon catheter

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Lutonix Catheter
  • Paclitaxel coated Balloon Catheter
• Active Comparator: Standard uncoated Balloon Angioplasty Catheter
  • uncoated angioplasty balloon

Primary Measures

• Angiographic late lumen loss
  • Time Frame: 6 months
    Safety Issue?: No

Secondary Measures

• Safety - Device related adverse events
  • Time Frame: 30 days
    Safety Issue?: Yes
• Primary patency of treated segment
  • Time Frame: 6, 12, 24 months
    Safety Issue?: No
• Target Lesion Revascularization
  • Time Frame: 6, 12, 24 months
    Safety Issue?: No
• Target Vessel Revascularization
  • Time Frame: 6, 12, 24 months
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Lutonix, Inc. Industry

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00930813

Study ID Number: CL0012-01

ClinicalTrials.gov Identifier: NCT00930813

Health Authority: Germany: Ethics Commission