A Study of The Femoral Popliteal Artery Treated With LEGFLOW OTW

Status Recruiting

Clinical Trial Summary

Clinical Trial Description

To evaluate the safety and efficacy of the Paclitaxel Releasing Peripheral Balloon Dilatation Catheter (LEGFLOW) compared with the standard balloon (Admiral Xtreme) for the treatment of stenosis or occlusions in femoral popliteal artery.

This is a prospective, multicenter, prior desiged, randomize and controlled study, planned to enrol 172 subjects. all these subjects will be allocated 1:1 to the LEGFLOW OTW group n=86 and Admiral Xtreme group n=86. and accept the treatment of LEGFLOW and Admiral Xtreme balloon. and followed up at day 0-30, month 6, 12 by DUS and clinical examination. all the endpoint data will be assessed by DUS core-lab, CEC, then be statisticed. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02965677
Study type	Interventional
Source	ZhuHai Cardionovum Medical Device Co., Ltd.
Contact	Guo Wei, professor
Phone	010-66938349
Email	pla301dml@vip.sina.com
Status	Recruiting
Phase	N/A
Start date	December 2016
Completion date	June 2021

View Details

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