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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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.

Conditions
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Atherosclerosis, Vascular Disease, Arteriosclerosis

Intervention / Treatment
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* Device: Lutonix Catheter
* Device: Standard uncoated Balloon Angioplasty Catheter


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lutonix Catheter<br>Paclitaxel coated Balloon Catheter | Device: Lutonix Catheter<br>* Paclitaxel Coated Balloon Catheter<br>* Other names: Drug coated balloon;|
| Active Comparator: Standard uncoated Balloon Angioplasty Catheter<br>uncoated angioplasty balloon | Device: Standard uncoated Balloon Angioplasty Catheter<br>* plain, uncoated angioplasty balloon catheter<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Angiographic Late Lumen Loss | Loss in analysis segment (the treated segment including 10mm distal and proximal) minimal lumen diameter from post-procedure through follow-up angiography at 6 months. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety - Device Related Adverse Events |  | 30 days | 
| Primary Patency of Treated Segment |  | 6, 12, 24 months | 
| Target Lesion Revascularization |  | 6, 12, 24 months | 
| Target Vessel Revascularization |  | 6, 12, 24 months | 
| Device Success | Successful delivery and deployment of the first inserted study device (in overlapping setting a successful delivery and deployment of the first and second study device) at the intended target lesion and successful withdrawal of the study device with attainment of final residual stenosis of less than 30% of the target lesion by quantitative vessel angiography (QVA). | at procedure | 
| Procedural Success | Completion of the procedure with less than 30% residual stenosis by QVA of the target lesion (after prolonged dilation and stenting, if necessary) | at procedure | 
| Change in Ankle-brachial Index |  | pre-procedure, 6, 12 and 24 months | 
| Change in Walking Impairment Questionnaire (WIQ) |  | pre-procedure, 6, 12 and 24 months | 
| Change in Rutherford Grade |  | pre-procedure,6, 12 and 24 months | 
| Serum Paclitaxel Levels - in Subsets of Patients |  | 0, 1, 3 hours and pre-discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PAD, Drug coated balloon, SFA disease, Femoropopliteal disease, Angioplasty, Paclitaxel, Tubulin modulators, Antineoplastic Agents, Mitosis Modulators, Balloon angioplasty, Local drug delivery, Restenosis, Drug-coated balloon