Randomized Controlled Trial Comparing endoAVF Versus surgAVF

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 he

Trial Eligibility

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.

Study Info

Interventions

Locations Recruiting

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