Peripheral Arterial Disease Clinical Trial
Official title:
Evaluation of the Safety and Efficacy of the Paclitaxel Eluting Hemodialysis Shunt Balloon Dilatation Catheter (APERTO) in Treatment of Hemodialysis Arteriovenous Fistulae Stenosis: A Prospective, Multicenter, Randomized, Controlled Clinical Study
To evaluate the safety and efficacy of Paclitaxel Eluting Hemodialysis Shunt Balloon Dilatation Catheter (APERTO) compared with the Balloon Dilatation catheter (OHICHO II) for the treatment of Arteriovenous Fistulae Stenosis in patients undergoing hemodialysis.
To evaluate the safety and efficacy of the Paclitaxel Eluting Hemodialysis Shunt Balloon
Dilatation Catheter (APERTO) compared with the Balloon Dilatation catheter (OHICHO II) for
the treatment of Arteriovenous Fistulae Stenosis in patients undergoing hemodialysis.
This is a prospective, multi-center, randomized controlled, open-label, superiority study. A
total of 160 subjects will be enrolled from 10 sites in China. All subjects enrolled will be
randomly assigned to the test group (APERTO group, n=80) and the control group (OHICHO II
group, n=80) with randomized allocation ratio of 1:1. Subjects in the test group and the
control group will be treated with APERTO OTW or OHICHO II respectively.
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