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ACTIVE NOT RECRUITING
NCT02408822
NA

Drug-Eluting Balloon Angioplasty for the Treatment of Hemodialysis Vascular Access Stenosis (DEBAVAS)

Sponsor: Centre Hospitalier Universitaire de Nice

View on ClinicalTrials.gov

Summary

Paclitaxel is an antiproliferative drug that can limit vascular intimal hyperplasia. Paclitaxel-coated balloons already have indications in the treatment of peripheral arterial disease. This randomized controlled trial is designed to prove the superiority of a drug-eluting balloon catheter (Paclitaxel-coated balloon) over a plain balloon catheter in the treatment of stenosed autogeneous and prosthetic vascular accesses, in hemodialysis patients. The hypothesis is that use of drug-eluting balloon will improve post-interventional patency of the access, and therefore, limit numbers and days of hospitalization for maintenance of hemodialysis vascular accesses.

Official title: Superiority of Drug-eluting Balloon Angioplasty Versus Plain Balloon Angioplasty for the Treatment of Hemodialysis Vascular Access Stenosis : a Multicentre, Randomized, Controlled Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

52

Start Date

2015-09-29

Completion Date

2026-06-15

Last Updated

2025-12-02

Healthy Volunteers

No

Interventions

DEVICE

PTA Balloon dilatation catheter Advance® (Cook® Medical)

2-minutes inflation of the plain balloon on pre-dilated stenosis segment, at nominal pressure

DEVICE

Drug-eluting PTA Balloon dilatation catheter Advance® 18 PTX®

2-minutes inflation of the drug-eluting balloon on pre-dilated stenosis segment, at nominal pressure

Locations (3)

CHU de Nice - Service de chirurgie vasculaire

Nice, France

Clinique St Georges

Nice, France

CHU de Reims

Reims, France