Drug-Eluting Balloon Angioplasty for the Treatment of Hemodialysis Vascular Access Stenosis (DEBA… (NCT02408822) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Drug-Eluting Balloon Angioplasty for the Treatment of Hemodialysis Vascular Access Stenosis (DEBAVAS)
France52 participantsStarted 2015-09-29
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 s…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Primary patency of the vascular access after endovascular angioplasty of a stenosis with drug-eluting balloon compared with treatment with plain-balloon