NCT02408822

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Centre Hospitalier Universitaire de Nice · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Introduction: Half of patients with hemodialysis vascular access will present at least one episode of dysfunction within 1 year after creation, mainly due to intimal hyperplasia and stenosis. Paclitaxel is an antiproliferative drug that can limit intimal hyperplasia in vessels. Paclitaxel-coated balloons already have indications in the treatment of peripheral arterial disease. Main objective: To show that the use of Paclitaxel-coated balloons to treat stenosis of vascular accesses will improve post-interventional patency and reduce numbers and days of hospitalization for access maintenance in hemodialysis vascular access. Hypothesis: Paclitaxel-coated balloon angioplasty (PTX) prolongs primary patency of the access after treatment of vascular access stenosis compared to plain balloon angioplasty (PBA)(standard treatment). Methodology: We designed a prospective, single-blinded, multicenter, randomized, controlled trial, which aim to enroll 120 patients. Patients diagnosed with a stenosis on their dysfunctional vascular access line (brachial-cephalic autogeneous fistula or brachial-axillary prosthetic graft) will be randomized to either arm of the study after completion of a successful pre-dilation with a standard plain balloon catheter. Randomization will be stratified according to type of access (brachial-cephalic autogeneous fistula or brachial-axillary prosthetic graft). Primary outcome measure will be primary patency of the vascular access at 12 months after treatment. Secondary outcome measures will be primary patency at 6 months, assisted-primary and secondary patencies at 6 and 12 months, number of re-interventions and number of days of hospitalization for re-intervention at 12 months. Clinical significance: By prolonging the vascular access lifespan, Paclitaxel-coated balloon angioplasty can limit morbidity and cost of vascular access maintenance for hemodialysis patients.

Conditions

• Dysfunction of Hemodialysis Vascular Access (Fistula and Graft)

Interventions

Type	Name	Description
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

Timeline

• Start date: 2015-09-29
• Primary completion: 2020-06-15
• Completion: 2026-06-15
• First posted: 2015-04-06
• Last updated: 2025-12-02

Locations

3 sites across 1 country: France