Comparing Surgical and Endovascular Arteriovenous Fistula Creation
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 thro
| Condition(s) | End Stage Renal Disease on Dialysis |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | 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 ver |
| Who can participate | 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 vei |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Lead sponsor | University of California, Los Angeles |
| Locations | Los Angeles, California, United States; Pittsburgh, Pennsylvania, United States |
| Start date | 2024-11-20 |
| NCT ID | NCT05654103 |
| Official listing | https://clinicaltrials.gov/study/NCT05654103 |