LEVANT Japan Clinical Trial

Femoral Artery Occlusion Clinical Trial

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

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constriction, Pathologic
• Femoral Arterial Stenosis
• Femoral Artery Occlusion
• Occlusion of Popliteal Arteries
• Stenosis of Popliteal Arteries

• NCT number: NCT01816412
• Study type: Interventional
• Source: C. R. Bard
• Status: Completed
• Phase: Phase 2
• Start date: March 2013
• Completion date: June 2016