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Drug-Eluting Balloon Angioplasty for the Treatment of Hemodialysis Vascular Access Stenosis (DEBAVAS)
Sponsor: Centre Hospitalier Universitaire de Nice
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
PTA Balloon dilatation catheter Advance® (Cook® Medical)
2-minutes inflation of the plain balloon on pre-dilated stenosis segment, at nominal pressure
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