Drug-Eluting Balloon Angioplasty for the Treatment of Hemodialysis Vascular Access Stenosis (DEBAVAS)
- Conditions
- Dysfunction of Hemodialysis Vascular Access (Fistula and Graft)
- Interventions
- Device: Drug-eluting PTA Balloon dilatation catheter Advance® 18 PTX®Device: PTA Balloon dilatation catheter Advance® (Cook® Medical)
- Registration Number
- NCT02408822
- Lead Sponsor
- Centre Hospitalier Universitaire de Nice
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 52
-
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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PTX Drug-eluting PTA Balloon dilatation catheter Advance® 18 PTX® (PacliTaXel-coated balloon angioplasty) Patient receiving endovascular treatment of a vascular access stenosis by drug-eluting balloon angioplasty (mechanical action + antiproliferative drug - Paclitaxel) 2-minutes inflation of the drug-eluting balloon on pre-dilated stenosis segment, at nominal pressure PBA (Plain Balloon Angioplasty) PTA Balloon dilatation catheter Advance® (Cook® Medical) Patient receiving endovascular treatment of a vascular access stenosis by plain balloon angioplasty (mechanical action, without drug) 2-minutes inflation of the plain balloon on pre-dilated stenosis segment, at nominal pressure
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Assisted-primary patency of the vascular access at 6 and 12 months after treatment Number of reinterventions (endovascular or surgery) after treatment during the follow-up (at 12 months) Primary patency of the vascular access at 6 months after treatment Days of hospitalization for reinterventions (endovascular or surgery) after treatment during the follow-up (at 12 months) Secondary patency of the vascular access at 6 and 12 months after treatment
Trial Locations
- Locations (3)
CHU de Reims
🇫🇷Reims, France
CHU de Nice - Service de chirurgie vasculaire
🇫🇷Nice, France
Clinique St Georges
🇫🇷Nice, France