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

NCT ID: NCT02408822

Last Updated: 2025-12-02

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-29
• Study Completion Date: 2026-06-15

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.

Conditions

Dysfunction of Hemodialysis Vascular Access (Fistula and Graft)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

PBA (Plain Balloon Angioplasty)

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

Group Type: ACTIVE_COMPARATOR

PTA Balloon dilatation catheter Advance® (Cook® Medical)

Intervention Type: DEVICE

2-minutes inflation of the plain balloon on pre-dilated stenosis segment, at nominal pressure

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

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

2-minutes inflation of the drug-eluting balloon on pre-dilated stenosis segment, at nominal pressure

Interventions

PTA Balloon dilatation catheter Advance® (Cook® Medical)

2-minutes inflation of the plain balloon on pre-dilated stenosis segment, at nominal pressure

Intervention Type: DEVICE

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

2-minutes inflation of the drug-eluting balloon on pre-dilated stenosis segment, at nominal pressure

Intervention Type: DEVICE

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
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

REDA HASSEN-KHODJA

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nice

Locations

CHU de Nice - Service de chirurgie vasculaire

Nice, , France

Clinique St Georges

Nice, , France

CHU de Reims

Reims, , France

Countries

France

Other Identifiers

15-AOI-03

Identifier Type: -

Identifier Source: org_study_id