A Safety and Efficacy Study of Hemodialysis Arteriovenous Fistulae Stenosis Treated With DissolveAV (NCT04226599) | Clinical Trial Compass
CompletedNot Applicable
A Safety and Efficacy Study of Hemodialysis Arteriovenous Fistulae Stenosis Treated With DissolveAV
China220 participantsStarted 2019-07-23
Plain-language summary
Drug-coated balloons delivering paclitaxel at the angioplasty site have proved their superiority in the treatment of coronary and peripheral arterial stenoses. Paclitaxel reduces neointimal hyperplasia, therefore, it represents an attractive option for AVF stenoses. This trial is aimed to evaluate the safety and efficacy of Peripheral scoring drug balloon (Dissolve AV) or Balloon Dilatation catheter ( Armada 35) in treating AVF stenosis in chinese population.
Who can participate
Age range
18 Years – 75 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
. Age 18-75 years (inclusive), male or female;
. Patients with mature AVF/AVG and at least one successful hemodialysis session;
. Target lesion located in the AVF/AVG reflux vein (excluding the feeding artery and central vein);
. With hemodynamically significant AVF/AVG stenosis and meeting two of the following conditions (A \& B) A. ≥ 50% stenosis of the target lesion as assessed by angiography B. Presence of at least one of the following (as defined in the NKF-K/DOQI guidelines) 1)Significantly elevated venous pressure during dialysis 2)Unexplained decrease in dialysis dose 3)Decrease in pump-controlled blood flow;
. De novo or restenotic target lesion consisting of one or more tandem lesions, and with a visual reference vessel diameter of 4.0-8.0 mm and a total length ≤ 40 mm for the target lesion;
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
Target lesion primary patency (TLPP) at 6 months post-procedure
. All non-target lesions must have \<50% stenosis without clinical indication for treatment.
. Patients who have signed the informed consent form.
Exclusion criteria
. Patients who are participating in another clinical trial of a drug product or medical device;
. Patients previously enrolled in this trial;
. Women of childbearing age with a non-negative pregnancy test prior to surgical procedure, or lactating women;
. Patients treated with major surgeries (e.g., open-heart surgery, cranial surgery) within 30 days prior to enrollment in the study;
. Immature AVF/AVG (not subjected to dialysis; this vascular access has not been subjected to a single successful dialysis due to insufficient inner diameter that prevents successful puncture and results in inadequate blood flow);
. Calcified lesions that are not expected to be dilated with a balloon;