Comparing Surgical and Endovascular Arteriovenous Fistula Creation for Dialysis

This study is comparing two ways to create an arteriovenous fistula (AVF) for patients with end-stage kidney disease (ESKD) who need hemodialysis. An AVF is a connection between an artery and a vein that helps with dialysis. One method is a traditional surgical AVF (surgAVF), which involves surgery. The other is an endovascular AVF (endoAVF), which uses a device inserted through the skin, often with local anesthesia instead of general anesthesia. The study aims to see which method leads to a "physiologically mature fistula" (meaning it's ready for use) after 6 months. You might be able to join if you are 18 to 99 years old, have ESKD and choose hemodialysis, and have certain vein measurements. The study is currently unclear on its recruitment status, but plans to enroll 90 participants.

Study design
This interventional study plans to enroll 90 participants. Participants will be randomly assigned by a computer to receive either the endoAVF or surgAVF procedure.
What's involved
You will undergo a vein mapping procedure, which is a standard ultrasound. If eligible, you will be screened further and then receive either the endoAVF or surgAVF procedure.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome, a physiologically mature fistula, will be measured at 6 months post-procedure.

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NCT05654103

Comparing Surgical and Endovascular Arteriovenous Fistula Creation

Active, Not Recruiting
NAAges 18–99InterventionalTreatment
University of California, Los Angeles
~90 participants
Updated 2026-08-10 on ClinicalTrials.gov
What's tested:endoAVFsurgAVF

At a glance

Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Physiologically mature fistula
Measured over 6 months postoperatively
End Stage Renal Disease on Dialysis
2 sites across 2 states
California1
Pennsylvania1
  • Karen Woo, MD, PhD · PRINCIPAL_INVESTIGATOR · University of California, Los Angeles

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

ESKD patients aged ≥ 18 who have chosen hemodialysis as their renal replacement option.
Ability to give consent to participate in a research study.
Upper arm vein diameter of ≥ 2.0 mm.
Confirmed radial artery-adjacent vein proximity ≤ 1.5 mm measured lumen edge-to-lumen edge as determined by preprocedural ultrasound and confirmed pre-procedurally.
Confirmed radial artery and adjacent vein diameter of ≥ 2.0 mm at site where vein and artery connects.
Target vein diameter ≥ 2.0 mm, target artery diameter ≥ 2.0 mm, and ≤ 2 mm between target artery and vein.

Exclusion

People under the age of 18.
Inability to understand the consent process and/or give consent.
Upper arm vein diameter less than 2.0 mm making them unsuitable to receive an surgAVF AND endoAVF.
Patients who are deemed by the surgeon to be anatomic candidates for a forearm vascular access, and the surgeon and the patient determine that a forearm access is the optimal access for the patient, in order to preserve more proximal anatomic sites for future accesses.
Currently incarcerated individuals.
Currently pregnant or planning to get pregnant within the next 6 months.
Individuals who choose peritoneal dialysis over hemodialysis and/or undergoing a kidney transplant within 6 months of randomization.
  • Physiologically mature fistula6 months postoperatively

    flow ≥ 500 ml/min and internal diameter \>0.5 cm