Inferior Genicular Artery Study for LEGFLOW OTW

NCT ID: NCT02962232


Title
To Evaluate the Safety and Efficacy of the Paclitaxel-eluting Peripheral Balloon Dilatation Catheter (LEGFLOW)in Treatment of Inferior Genicular Artery Stenosis or Occlusion: A Prospective, Multicenter, Randomized, Control Clinical Study
Purpose
To evaluate the safety and efficacy of the paclitaxel-eluting peripheral balloon dilatation catheter (LEGFLOW) compare to the PTA catheter (AMPHIRION DEEP).in treatment of inferior genicular artery stenosis or occlusion.
Details
To evaluate the safety and efficacy of the paclitaxel-eluting peripheral balloon dilatation catheter (LEGFLOW) compare to the PTA catheter (AMPHIRION DEEP).in treatment of inferior genicular artery stenosis or occlusion. This is a prospective, multi-center, randomized, control, opening, superiority designed clinical study. Plan to enroll 172 eligible subjects in 15 centers in China, all these subjects will be randomized 1:1 to the study group (LEGFLOW OTW group, n=86) and control group (AMPHIRION DEEP group, n=86), and accept the treatment of LEGFLOW OTW and AMPHIRION DEEP respectively.
Conditions
Peripheral Artery Disease
Keywords
drug eluting balloon, inferior genicular artery
Source
ZhuHai Cardionovum Medical Device Co., Ltd.
Sponsors
ZhuHai Cardionovum Medical Device Co., Ltd.
Status
Not yet recruiting
Acronym
Last Updated
09 Nov 2016
URL
Official Link
Locations
China