NCT05654103

Comparing Surgical and Endovascular Arteriovenous Fistula Creation

Recruiting now NA Last updated 29 October 2025

What this trial tests

NA trial testing endoAVF in End Stage Renal Disease on Dialysis in 90 participants. Currently enrolling.

Timeline

20 November 2024

Primary endpoint
1 December 2027

1 January 2028

Quick facts

Lead sponsor	University of California, Los Angeles
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	90
Start date	20 November 2024
Primary completion	1 December 2027
Estimated completion	1 January 2028
Sites	2 locations across United States

Drugs / interventions tested

• endoAVF
• surgAVF

Conditions studied

• End Stage Renal Disease on Dialysis — all drugs for End Stage Renal Disease on Dialysis →

Sponsor

University of California, Los Angeles

Who can join

Adults 18 to 99, any sex, with End Stage Renal Disease on Dialysis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Patients with end-stage kidney disease (ESKD) who use hemodialysis to filter their blood require vascular access for the dialysis machine; the most common type of vascular access is called an arteriovenous fistula (AVF). The AVF is a direct connect between an artery and vein.

Until recently, AVFs were only created through surgery that requires general anesthesia and opening up the skin. Now there are 2 FDA-approved devices designed to create AVFs using endovascular techniques (endoAVF), which means a device that goes through the skin instead of opening the skin up. Also patients are not required to be under general anesthesia, they can receive local anesthesia instead. Due to the relatively new approval of these devices, there is not a randomized study to compare the results of endoAVF versus surgAVF.

This study is a pilot study for an eventually larger scale study to compare the results of endoAVF versus surgAVF. The study aims to determine what the proportion of patients seeking hemodialysis access could qualify for receiving either an endoAVF , surgAVF, or both. Patients who are screened for hemodialysis access must undergo a duplex ultrasound of the blood vessels in the arm to confirm correct sizing. If participants qualify for both procedures they will be randomized to either endoAVF or surgAVF and will track the clinical and patient-reported outcomes of each procedure. Our pilot study hopes to enroll 90 participants. Those outcomes will inform a larger scale study. If the potential participant chooses to abstain from participation in the randomized trial, preferring to decide the method of AVF creation, we will offer to them a chance to join an endoAVF/surgAVF registry that will track the clinical outcomes of the procedure via medical record monitoring.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.