Clinical trial NCT02408822: Drug-Eluting Balloon Angioplasty for the Treatment of Hemodialysis Vascular Access Stenosis (DEBAVAS)
Official title: Superiority of Drug-eluting Balloon Angioplasty Versus Plain Balloon Angioplasty for the Treatment of Hemodialysis Vascular Access Stenosis : a Multicentre, Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dysfunction of Hemodialysis Vascular Access (Fistula and Graft)
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2015-04-06
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Primary patency of the vascular access after endovascular angioplasty of a stenosis with drug-eluting balloon compared with treatment with plain-balloon
timeFrame: at 12 months
Secondary outcomes:
measure: Primary patency of the vascular access
timeFrame: at 6 months after treatment
measure: Assisted-primary patency of the vascular access
timeFrame: at 6 and 12 months after treatment
measure: Secondary patency of the vascular access
timeFrame: at 6 and 12 months after treatment
measure: Number of reinterventions (endovascular or surgery)
timeFrame: after treatment during the follow-up (at 12 months)
measure: Days of hospitalization for reinterventions (endovascular or surgery)
timeFrame: after treatment during the follow-up (at 12 months)
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de Nice - Service de chirurgie vasculaire
city: Nice
country: France
facility: Clinique St Georges
city: Reims
country: France
facility: CHU de Reims
Study officials:
affiliation: Centre Hospitalier Universitaire de Nice
name: REDA HASSEN-KHODJA
role: PRINCIPAL_INVESTIGATOR
References: