Randomized Controlled Trial Comparing Endovascular and Surgical Arteriovenous Fistula Creation for Patients with End-Stage Kidney Disease on Hemodialysis

What this Trial Is About

Researchers are studying patients with end-stage kidney disease (ESKD) who need hemodialysis and require vascular access called an arteriovenous fistula (AVF). This trial compares two methods of creating AVFs: traditional surgery (surgAVF) and newer endovascular devices (endoAVF) that use less invasive techniques without general anesthesia. The goal is to see which method suits more patients and to track the outcomes of each approach in a randomized pilot study that will inform larger future studies. Participants will undergo vein mapping using duplex ultrasound to confirm if their veins are suitable for AVF creation. Those eligible for both methods will be randomly assigned to receive either surgAVF, involving surgery under general anesthesia, or endoAVF, where an FDA-approved device creates AVF through the skin with local anesthesia. Additional ultrasound checks help determine the appropriate endoAVF device if assigned. Those who decline randomization can join a registry tracking their treatment outcomes. During the study, participants will be followed for two years, with in-person visits at 35, 90, and 180 days after the procedure to assess clinical and patient-reported outcomes and physical fistula exams. Monthly chart reviews will monitor adverse events, dialysis methods, and any additional procedures needed. Registry participants will have their outcomes tracked through medical records and complete a brief questionnaire. The main outcome measured is physiologically mature fistula at six months post-procedure.

Comparing Surgical and Endovascular Arteriovenous Fistula Creation