Drug-Eluting Balloon Angioplasty for the Treatment of Hemodialysis Vascular Access Stenosis (DEBAVAS) (B3AV)

Centre Hospitalier Universitaire de Nice

Status: Active, not recruiting

Conditions: Dysfunction of Hemodialysis Vascular Access (Fistula and Graft)

Treatments: Device: PTA Balloon dilatation catheter Advance® (Cook® Medical); Device: Drug-eluting PTA Balloon dilatation catheter Advance® 18 PTX®

Study type: Interventional

Funder types: Other

Identifiers

NCT02408822

15-AOI-03

Details and patient eligibility

About

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.

Full 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.

Enrollment: 52 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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52 participants in 2 patient groups

PBA (Plain Balloon Angioplasty)

Active Comparator group

Description:

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

Treatment:

Device: PTA Balloon dilatation catheter Advance® (Cook® Medical)

PTX

Experimental group

Description:

(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

Treatment:

Device: Drug-eluting PTA Balloon dilatation catheter Advance® 18 PTX®