Superiority of Drug-eluting Balloon Angioplasty Versus Plain Balloon Angioplasty for the Treatment of Hemodialysis Vascular Access Stenosis : a Multicentre, Randomized, Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Dysfunction of Hemodialysis Vascular Access (Fistula and Graft)
- Sponsor
- Centre Hospitalier Universitaire de Nice
- Enrollment
- 52
- Locations
- 3
- Primary Endpoint
- Primary patency of the vascular access after endovascular angioplasty of a stenosis with drug-eluting balloon compared with treatment with plain-balloon
- Status
- Active, not recruiting
- Last Updated
- 5 months ago
Overview
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.
Investigators
Eligibility Criteria
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
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
Outcomes
Primary Outcomes
Primary patency of the vascular access after endovascular angioplasty of a stenosis with drug-eluting balloon compared with treatment with plain-balloon
Time Frame: at 12 months
Secondary Outcomes
- 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)