Peripheral Artery Disease Clinical Trial
Official title:
Evaluation the Safety and Efficacy of the Paclitaxel Releasing Peripheral Balloon Dilatation Catheter （LEGFLOW）in Treatment of Stenosis or Occlusion in Below The Knee Arteries: A Prospective, Multicenter, Randomized, Controlled Clinical Study
To evaluate the safety and efficacy of the Paclitaxel Releasing Peripheral Balloon Dilatation Catheter (LEGFLOW) compared to the PTA catheter (AMPHIRION DEEP) in treatment of stenosis or occlusion in below the knee artery.
To evaluate the safety and efficacy of the Paclitaxel Releasing Peripheral Balloon Dilatation
Catheter (LEGFLOW) compared to the PTA catheter (AMPHIRION DEEP) in treatment of stenosis or
occlusion inbelow the knee artery.
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.
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