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Active, not recruiting Not applicable

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

NCT02408822 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2015-09-29
Last updated
2025-12-02

Condition(s) studied

Dysfunction of Hemodialysis Vascular Access (Fistula and Graft)

Investigational drug(s) / intervention(s)

PTA Balloon dilatation catheter Advance® (Cook® Medical)Drug-eluting PTA Balloon dilatation catheter Advance® 18 PTX®

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Patient must be 18 years of age or older at the time of signing and dating informed consent (no upper age limit), can be male or female. * Patient must have a vascular access for hemodialysis (type: brachial-cephalic autogeneous fistula or brachial-axillary prosthetic graft) * Patient must have a dysfunction of its vascular access, defined by : * dialysis sessions last \>4 hours * and/or access flow \< 400ml/min for fistulae and \<600ml for grafts, or 20% decrease in access flow as monitored during dialysis or by Duplex ultrasound scan, * and/or dialysis recirculation * and/or thrill not perceived * and/or pulsatile vascular access * and/or bleeding or increased bleeding time after puncture * A stenosis \>50% of the venous line must be diagnosed on the initial fistulogram * A successful plain balloon angioplasty of the stenosis, defined by residual stenosis \<30% on control angiogram, without dissection or indication for use of stent or additional surgical procedure, must be completed before inclusion. Exclusion Criteria: * Pregnant or nursing woman, or plans to become pregnant during the study. * Patient has hyperkalemia \>6,5 mmol/L with EKG modifications or acute cardiac insufficiency at the time of inclusion * Vascular access has in-stent restenosis * Initial fistulogram shows no stenosis * Initial fistulogram shows indication for open surgical intervention * Control fistulogram (after plain balloon angioplasty) shows indication for stenting or open surgical intervention

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)

FacilityCityRegionStatus
CHU de Nice - Service de chirurgie vasculaire Nice France
Clinique St Georges Nice France
CHU de Reims Reims France
Official registry record

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