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A Single Arm Trial Evaluating the BARD Lutonix Drug-Coated Balloon (LTX DCB) for Treatment of Femoropopliteal Arteries

Femoral Artery Occlusion Clinical Trial

Official title:
A Prospective, Multicenter, Single Arm Trial Evaluating the BARD Lutonix Drug-Coated Balloon (LTX DCB) for Treatment of Femoropopliteal Arteries (LEVANT China)

Clinical Trial Summary

To assess the safety and efficacy of the BARD LTX DCB for treatment of stenosis or occlusion of the superficial femoral and popliteal arteries.

Clinical Trial Description

The study will enroll patients presenting with claudication or ischemic rest pain due to stenotic lesions in the superficial femoral or popliteal artery and a patent outflow artery to the foot. After successful pre-dilatation, subjects determined by the investigator not to require stenting based on defined angiographic criteria will receive the BARD LTX DCB. . ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02720003
Study type Interventional
Source C. R. Bard
Contact
Status Completed
Phase N/A
Start date March 2016
Completion date August 2020
View Details
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