drug-eluting balloon angioplasty for the treatment of hemodialysis vascular access stenosis (debavas)

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

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.

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