Dysfunction of Hemodialysis Vascular Access (Fistula and Graft)
Conditions
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.
Interventions
DEVICEPTA Balloon dilatation catheter Advance® (Cook® Medical)
2-minutes inflation of the plain balloon on pre-dilated stenosis segment, at nominal pressure
DEVICEDrug-eluting PTA Balloon dilatation catheter Advance® 18 PTX®
2-minutes inflation of the drug-eluting balloon on pre-dilated stenosis segment, at nominal pressure
Sponsors
Centre Hospitalier Universitaire de Nice
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | 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) |
Countries
France
Outcome results
None listed