LEVANT Japan Clinical Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2016-06-30

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.

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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LDCB

Paclitaxel Coated Balloon

Group Type EXPERIMENTAL

MD02-LDCB Paclitaxel coated balloon catheter

Intervention Type DEVICE

PTA

Standard Uncoated Balloon Angioplasty Catheter PTA Catheter

Group Type ACTIVE_COMPARATOR

Standard Uncoated Balloon Angioplasty Catheter

Intervention Type PROCEDURE

Interventions

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MD02-LDCB Paclitaxel coated balloon catheter

Intervention Type DEVICE

Standard Uncoated Balloon Angioplasty Catheter

Intervention Type PROCEDURE

Other Intervention Names

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PTA Catheter

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No