Arteriovenous Fistulae: Drug-eluting Balloon Angioplasty (FAVABED)
Stenosis of Arteriovenous Dialysis Fistula
About this trial
This is an interventional treatment trial for Stenosis of Arteriovenous Dialysis Fistula
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 18,
- Stage 5 renal failure patients on permanent haemodialysis treatment (every 2 or 3 days),
- Native and efficient arteriovenous fistula > 3 months,
- 3mm ≤ reference vein diameter ≤ 8 mm and stenosis length ≤ 10 cm (range of DEB diameters and lengths),
- Absence of fistula thrombosis,
- Possibility of crossing the stenosis with a guide wire,
- Significant stenosis > 50% (in relation to the reference diameter) on the fistulogram,
Clinical diagnosis of imminent fistula dysfunction
- pressure rise during dialysis
- and/or puncture difficulties
- and/or recirculation or poor extrarenal clearance
- and/or decrease in vascular access flow
- and/or increase in compression time after dialysis
- Social security affiliation,
- Receipt of free, informed, written consent.
Exclusion Criteria:
- Multiple stenoses,
- Goretex® graft prostheses
- Systemic or local infection,
- Known allergy to contrast agent or Paclitaxel.
- Comorbidity not permitting long-term follow-up,
- Life expectancy < 1 year,
- Anticancer treatment (patients treated with chemotherapy for neoplasia),
- Pregnant or breastfeeding woman,
- Patients over 18 years of age who are under legal protection (conservatorship, trusteeship, guardianship), or deprived of freedom.
Sites / Locations
- CHU Bordeaux
- Centre Hospitalier Universitaire de Caen
- Centre Hospitalier Universitaire de Clermont-FerrandRecruiting
- Centre Hospitalier d'HaguenauRecruiting
- APHM Hôpital la TimoneRecruiting
- Centre Hospitalier Universitaire de MontpellierRecruiting
- Hôpital Européen Georges PompidouRecruiting
- Centre Hospitalier Universitaire de RENNESRecruiting
- Centre Hospitalier Universitaire de ToulouseRecruiting
- Clinique St Gatien de ToursRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
"DEB" arm
"conventional angioplasty" arm
dilation by a high-pressure conventional angioplasty balloon (sized to fit the reference native vein diameter) until disappearance of the stenotic obstructive area and achievement of technical success (possibility of changing balloon size or dilation pressure) then dilation by a DEB.
dilation will be performed by a conventional high-pressure balloon until technical success is achieved (possibility of changing balloon size or dilation pressure), then by a sham balloon i.e a conventional low-pressure balloon (placebo)