FLEX Vessel Prep Prior to Angioplasty in Native Arteriovenous Fistulae (AVF) (NCT05034939) | Clinical Trial Compass
CompletedNot Applicable
FLEX Vessel Prep Prior to Angioplasty in Native Arteriovenous Fistulae (AVF)
United States75 participantsStarted 2021-09-02
Plain-language summary
A prospective, multi-center, randomized observational post-market study evaluating the FLEX Vessel Prep device plus percutaneous angioplasty (PTA) vs PTA alone for the treatment of obstructive lesions in the native arteriovenous dialysis fistulae.
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
. Patient is ≥21 years of age.
. Patient has a life expectancy of ≥12 months.
. Patient has a native AV fistula created ≥ 60 days prior to the index procedure.
. The target AV fistula has undergone successful dialysis for at least 8 of 12 sessions during a four-week period.
. Patient has a de novo and/or non-stented restenotic lesion located between approximately 2 cm proximal to the arteriovenous anastomosis and axillosubclavian junction with ≥50% stenosis.
. Patient has a target lesion (which may include a tandem lesion) that is ≤ 100 mm in length (by visual estimate).
. Patient has a target vessel diameter of 4.0 - 12.0 mm (by visual estimate)
. Patient underwent successful crossing of the target lesion with the guidewire.
Exclusion criteria
. Patient is pregnant or breastfeeding.
. Patient is receiving immunosuppressive therapy.
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.