Comparing Surgical and Endovascular Arteriovenous Fistula Creation

Launched by UNIVERSITY OF CALIFORNIA, LOS ANGELES · Dec 8, 2022

Keywords

ClinConnect Summary

This clinical trial is studying two different ways to create an arteriovenous fistula (AVF), which is a connection between an artery and a vein that people with end-stage kidney disease need for hemodialysis. Traditionally, this procedure required surgery and general anesthesia, but now there are new devices that allow doctors to create an AVF using a less invasive method called endovascular techniques, which can be done with local anesthesia instead. The goal of this pilot study is to see how many patients needing hemodialysis can qualify for either method of creating an AVF and to gather information about the outcomes of each procedure.

To participate, you need to be over 18 years old and have chosen hemodialysis as your treatment for kidney failure. You also need to have certain measurements in your arm veins to ensure they're suitable for the procedure. If you qualify for both methods, you will be randomly assigned to either the surgical or endovascular method, and your progress will be tracked. If you prefer to choose which method you would like, you can still join a registry that monitors the outcomes of your treatment. The study aims to enroll about 90 participants and will help guide future research on these techniques.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• Ellipsys specific inclusion criteria:
• • 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.
• WavelinQ specific inclusion criteria:
• • Target vein diameter ≥ 2.0 mm, target artery diameter ≥ 2.0 mm, and ≤ 2 mm between target artery and vein.
• Exclusion Criteria:
• • 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.

Trial Officials