Arteriovenous Fistula: Conventional Angioplasty vs Drug Eluting Balloon-assisted Maturation Inter… (NCT03068845) | Clinical Trial Compass
UnknownPhase 3
Arteriovenous Fistula: Conventional Angioplasty vs Drug Eluting Balloon-assisted Maturation Intervention Clinical Trial
124 participantsStarted 2017-06
Plain-language summary
The purpose of this randomised clinical trial is to evaluate the efficacy of drug-eluting balloon compared to conventional balloon in balloon-assisted maturation of non-maturing arteriovenous fistula in adult renal failure patients.
Who can participate
Age range
21 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
. Non-maturing upper limb arteriovenous fistula (AVF) created 6-24 weeks ago with any one of the following:
. Non-maturing on physical examination, or
. Failed initial cannulation, or
. Failure to achieve prescribed dialysis within prescribed time frame.
. Stenosis (\>50%) along AVF circuit from anastomosis up to, but not including, the subclavian vein.
. Successful guidewire crossing of target lesion.
. \>= 21 years old.
. Informed consent given.
Exclusion criteria
. Thrombosed non-maturing AVF
. Target lesion is longer than 8 cm
. Previous endovascular therapy for non-maturation of the trial AVF
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
Fistula used successfully for haemodialysis (FUSH)
. Baseline systolic blood pressure less than 100 mmHg
. Non-maturing AVF is not planned to be used for dialysis in the immediate future (e.g. chronic kidney disease not requiring haemodialysis yet)
. Coagulopathy (prothrombin time or activated partial thromboplastin time \>1.5 times the median of normal range) that cannot be managed adequately with periprocedural transfusion
. Thrombocytopenia (platelet count \<50,000 /μL) that cannot be managed adequately with periprocedural transfusion
. Known allergy to iodinated contrast that cannot be managed adequately with pre-procedure medication