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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Dysfunction of Hemodialysis Vascular Access (Fistula and Graft)

Intervention / Treatment
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* Device: PTA Balloon dilatation catheter Advance® (Cook® Medical)
* Device: Drug-eluting PTA Balloon dilatation catheter Advance® 18 PTX®


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PBA (Plain Balloon Angioplasty)<br>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 | Device: PTA Balloon dilatation catheter Advance® (Cook® Medical)<br>* 2-minutes inflation of the plain balloon on pre-dilated stenosis segment, at nominal pressure<br>|
| Experimental: PTX<br>(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 | Device: Drug-eluting PTA Balloon dilatation catheter Advance® 18 PTX®<br>* 2-minutes inflation of the drug-eluting balloon on pre-dilated stenosis segment, at nominal pressure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary patency of the vascular access |  | at 6 months after treatment | 
| Assisted-primary patency of the vascular access |  | at 6 and 12 months after treatment | 
| Secondary 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) | 
| Days of hospitalization for reinterventions (endovascular or surgery) |  | after treatment during the follow-up (at 12 months) |