TerminatedNot Applicable

Outcomes for One-stage and Two-stage Brachial Basilic Arteriovenous Fistulas

Stopped: The PI is leaving the institution and the trial will be not resuming.

United States2 participantsStarted 2021-10-01

Plain-language summary

An arteriovenous (AV) fistula is essential for patients with kidney failure on dialysis. There is no clear data on the best method to create a new brachial basilic AV fistula (BBAVF), so the choice between a single procedure and two separate procedures is left to the surgeon. Both approaches are standard care. This study aims to compare patient-centered outcomes and quality of life by randomly assigning patients needing a BBAVF to either a one-stage or two-stage procedure.

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

. Age ≥ 18 years;
. ESRD receiving hemodialysis in need for new hemodialysis access;
. Candidate for one-stage and two-stage BVT procedure as judged by the enrolling investigator;
. Greater than 3 mm diameter of upper arm basilic vein on venous duplex scan;
. Life expectancy ≥ 12 months;

Exclusion criteria

. Life expectancy \< 12 months;
. Brachial artery stenosis or occlusion;

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

Number of Participants Who Had Successful Use of Arteriovenous Fistula for Dialysis

Timeframe: 6 months

Trial details

NCT IDNCT04376567

SponsorTze-Woei Tan

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-11-01

Results submitted2025-03-07

View on ClinicalTrials.gov More End Stage Renal Failure trials