NCT04226599

A Safety and Efficacy Study of Hemodialysis Arteriovenous Fistulae Stenosis Treated With DissolveAV

Evaluation of the Safety and Efficacy of the Peripheral Scoring Drug Balloon (Dissolve AV) in Treatment of Hemodialysis Arteriovenous Fistulae Stenosis A Prospective Multicenter Randomized Controlled Clinical Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 220 (actual)
• Sponsor: DK Medical Technology (Suzhou) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Drug-coated balloons delivering paclitaxel at the angioplasty site have proved their superiority in the treatment of coronary and peripheral arterial stenoses. Paclitaxel reduces neointimal hyperplasia, therefore, it represents an attractive option for AVF stenoses. This trial is aimed to evaluate the safety and efficacy of Peripheral scoring drug balloon (Dissolve AV) or Balloon Dilatation catheter ( Armada 35) in treating AVF stenosis in chinese population.

Detailed description

This is a prospective, multi-center, randomized controlled, open-label, superiority study. A total of 220 subjects will be enrolled from 11 sites in China. All subjects enrolled will be randomly assigned to the test group (Dissolve AV group, n=110) and the control group (Armada 35 group, n=110) with randomized allocation ratio of 1:1. Subjects in the test group and the control group will be treated with Peripheral scoring drug balloon or Balloon Dilatation catheter

Conditions

• Fistulas Arteriovenous

Interventions

Type	Name	Description
DEVICE	Dissolve AVF	Subjects in the test group will be treated with peripheral scoring drug balloon.
DEVICE	Armada 35	Subjects in the test group will be treated with plain balloon catheter.

Timeline

• Start date: 2019-07-23
• Primary completion: 2021-10-02
• Completion: 2022-01-04
• First posted: 2020-01-13
• Last updated: 2025-02-11

Locations

10 sites across 1 country: China