Comparing two methods for creating vascular access in dialysis patients

Randomized Controlled Trial Comparing endoAVF Versus surgAVF

This study is testing two different ways to create access points for dialysis in patients with severe kidney disease to see which method works better.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 18 Years to 99 Years
• Sex: All
• Sponsor: University of California, Los Angeles (other)
• Locations: 2 sites (Los Angeles, California and 1 other locations)
• Trial ID: NCT05654103 on ClinicalTrials.gov

What this trial studies

This pilot study aims to compare the effectiveness of two methods for creating arteriovenous fistulas (AVFs) in patients with end-stage kidney disease who require hemodialysis. One method is the traditional surgical approach, while the other utilizes newer endovascular techniques that are less invasive and can be performed under local anesthesia. Patients will undergo vein mapping to assess suitability and will be randomized to receive either method. The study seeks to gather data that could inform a larger scale trial in the future.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with end-stage kidney disease who have chosen hemodialysis and have suitable upper arm vein diameters.

Not a fit: Patients under 18 or those with unsuitable vein diameters for either method will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved vascular access options for dialysis patients, potentially enhancing their treatment experience and outcomes.

How similar studies have performed: While this approach is relatively novel, there have been no prior randomized studies directly comparing these two methods for AVF creation.

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.

Where this trial is running

Los Angeles, California and 1 other locations

• UCLA Division of Vascular and Endovascular Surgery Clinic — Los Angeles, California, United States (RECRUITING)
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States (RECRUITING)

Study contacts

• Principal investigator: Karen Woo, MD, PhD — University of California, Los Angeles
• Study coordinator: Kate Horiuchi, MPH

Conditions: End Stage Renal Disease on Dialysis, hemodialysis, arteriovenous fistula, fistula, endoAVF, End Stage Renal Disease