NCT02962141

A Study of Hemodialysis Arteriovenous Fistulae Stenosis Treated With APERTO

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 161 (actual)
• Sponsor: ZhuHai Cardionovum Medical Device Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Peripheral Arterial Disease
• Fistula

Interventions

Type	Name	Description
DEVICE	Paclitaxel Releasing Peripheral Balloon Dilatation Catheter	Treatment group
DEVICE	Balloon Dilatation Catheter	Control group

Timeline

• Start date: 2016-10-01
• Primary completion: 2018-01-01
• Completion: 2019-06-01
• First posted: 2016-11-11
• Last updated: 2019-08-07

Locations

9 sites across 1 country: China