LEVANT Japan Clinical Trial

Study Overview
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Brief Summary
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To demonstrate the safety and efficacy of MD02-LDCB for treatment of stenosis or occlusion of the femoral and popliteal arteries in the Japanese population.

Detailed Description
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The study will enroll patients presenting with claudication or ischemic rest pain and an angiographically significant lesion in the superficial femoral or popliteal artery and a patent outflow artery to the foot. After successful protocol-defined pre-dilatation, subjects that are determined not to require stenting based on defined angiographic criteria are randomized 2:1 to treatment with either MD02-LDCB (test arm) or standard PTA catheter (control arm) using similar techniques. Subjects that do not meet post-predilatation lesion criteria are excluded (and treated per standard practice) and followed for safety for 30 days. Randomized subjects will have ultrasound follow-up through 2 years and are consented for up to 2 years clinical follow-up.

Official Title
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A Prospective, Multicenter, Single Blind, Randomized, Controlled Japanese Population Trial Comparing MD02-LDCB Versus Standard Balloon Angioplasty for Treatment of Femoropopliteal Arteries

Conditions
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Femoral Arterial Stenosis, Stenosis of Popliteal Arteries, Femoral Artery Occlusion, Occlusion of Popliteal Arteries

Intervention / Treatment
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* Device: MD02-LDCB Paclitaxel coated balloon catheter
* Procedure: Standard Uncoated Balloon Angioplasty Catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or non-pregnant female ≥20 years of age; Rutherford Clinical Category 2-4; Length ≤15 cm; ≥70% stenosis Lesion location starts ≥1 cm below the common femoral bifurcation and terminates distally ≤2 cm below the tibial plateau AND ≥1 cm above the origin of the TP trunk; A patent inflow artery as confirmed by angiography At least one patent native outflow artery to the ankle Exclusion Criteria: Life expectancy of < 2 years; History of hemorrhagic stroke within 3 months; Previous or planned surgical or interventional procedure within 2 weeks before or within 30 days after the index procedure; History of MI, thrombolysis or angina within 2 weeks of enrollment; Renal failure or chronic kidney disease Severe calcification that renders the lesion un-dilatable

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 100 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: LDCB<br>Paclitaxel Coated Balloon | Device: MD02-LDCB Paclitaxel coated balloon catheter<br> <br> |
| Active Comparator: PTA<br>Standard Uncoated Balloon Angioplasty Catheter PTA Catheter | Procedure: Standard Uncoated Balloon Angioplasty Catheter<br> <br> * Other names: PTA Catheter;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of freedom from all-cause peri-operative (≤30 day) death and freedom at 6 months from the following: index limb amputation (above or below the ankle), index limb re-intervention, and index-limb-related death. | Primary Patency | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | Composite of freedom from all-cause peri-operative (≤30 day) death and freedom at 6 months from the following: index limb amputation (above or below the ankle), index limb re-intervention, and index-limb-related death. | 1, 3, 6, 12 and 24 months | 
| Efficacy | Primary Patency of the target lesion at 6 months. Primary Patency is defined as the absence of target lesion restenosis (defined by DUS peak systolic velocity ratio (PSVR) ≥2.5) and freedom from target lesion revascularization (TLR). | 1, 3, 6, 12 and 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Arms, Experimental, Drug Coated Angioplasty Balloon, Standard angioplasty balloon, Active Comparator