Dysfunction of Hemodialysis Vascular Access (Fistula and Graft) Clinical Trial
— B3AVOfficial title:
Superiority of Drug-eluting Balloon Angioplasty Versus Plain Balloon Angioplasty for the Treatment of Hemodialysis Vascular Access Stenosis : a Multicentre, Randomized, Controlled Trial
| Verified date | November 2023 |
| Source | Centre Hospitalier Universitaire de Nice |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 52 |
| Est. completion date | June 15, 2023 |
| Est. primary completion date | June 15, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | CHU de Nice - Service de chirurgie vasculaire | Nice | |
| France | Clinique St Georges | Nice | |
| France | CHU de Reims | Reims |
| Lead Sponsor | Collaborator |
|---|---|
| Centre Hospitalier Universitaire de Nice |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | ||
| Secondary | Primary patency of the vascular access | at 6 months after treatment | ||
| Secondary | Assisted-primary patency of the vascular access | at 6 and 12 months after treatment | ||
| Secondary | Secondary patency of the vascular access | at 6 and 12 months after treatment | ||
| Secondary | Number of reinterventions (endovascular or surgery) | after treatment during the follow-up (at 12 months) | ||
| Secondary | Days of hospitalization for reinterventions (endovascular or surgery) | after treatment during the follow-up (at 12 months) |