Comparing Surgical and Endovascular Arteriovenous Fistula Creation
End Stage Renal Disease on Dialysis
About this trial
This is an interventional treatment trial for End Stage Renal Disease on Dialysis focused on measuring hemodialysis, arteriovenous fistula, fistula, endoAVF, End Stage Renal Disease
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.
Sites / Locations
- UCLA Division of Vascular and Endovascular Surgery Clinic
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
surgAVF
endoAVF
Participant will undergo fistula creation through surgical means, which requires undergoing general anesthesia and opening the skin to create the fistula.
Participant will undergo fistula creation through endovascular surgical means, which does not require general anesthesia and is created by using a device that goes through the skin to create the fistula. The two devices that are currently FDA approved and used to create the endoAVF are the WavelinQ™ EndoAVF System and the Ellipsys® Vascular Access System.