Drug-Eluting Balloon Angioplasty for the Treatment of Hemodialysis Vascular Access Stenosis (DEBAVAS)
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Study 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.
Eligibility
Primary outcome measure(s)
- Primary patency of the vascular access after endovascular angioplasty of a stenosis with drug-eluting balloon compared with treatment with plain-balloon — at 12 months
Trial sites (3)
| Facility | City | Region | Status |
|---|---|---|---|
| CHU de Nice - Service de chirurgie vasculaire | Nice | France | |
| Clinique St Georges | Nice | France | |
| CHU de Reims | Reims | France |
More Centre Hospitalier Universitaire de Nice trials in France
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT02408822 on ClinicalTrials.gov ↗ ← All trials in France