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

2016-03-29 10:07:51 | BioPortfolio

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.

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Femoral Artery Stenosis

Intervention

LTX DCB

Location

Beijing Anzhen Hospital, Capital Medical University
Beijing
Beijing
China
100029

Status

Not yet recruiting

Source

C. R. Bard

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-03-29T10:07:51-0400

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Medical and Biotech [MESH] Definitions

A groin hernia occurring inferior to the inguinal ligament and medial to the FEMORAL VEIN and FEMORAL ARTERY. The femoral hernia sac has a small neck but may enlarge considerably when it enters the subcutaneous tissue of the thigh. It is caused by defects in the ABDOMINAL WALL.

The main artery of the thigh, a continuation of the external iliac artery.

An extra-anatomic method of surgical revascularization in which the AXILLARY ARTERY is anastomosed to FEMORAL ARTERY.

The vein accompanying the femoral artery in the same sheath; it is a continuation of the popliteal vein and becomes the external iliac vein.

The continuation of the femoral artery coursing through the popliteal fossa; it divides into the anterior and posterior tibial arteries.

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