Randomized Controlled Trial Comparing endoAVF Versus surgAVF
University of California, Los Angeles
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 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 hemodialysis access could qualify for receiving either an endoAVF , surgAVF, or both. Patients who are screened for hemodialysis access must undergo a duplex ultrasound of the blood vessels in the arm to confirm correct sizing. If participants qualify for both procedures they will be randomized to either endoAVF or surgAVF and will track the clinical and patient-reported outcomes of each procedure. Our pilot study hopes to enroll 90 participants. Those outcomes will inform a larger scale study. If the potential participant chooses to abstain from participation in the randomized trial, preferring to decide the method of AVF creation, we will offer to them a chance to join an endoAVF/surgAVF registry that will track the clinical outcomes of the procedure via medical record monitoring.
Description
All individuals being considered for a AVF undergo a procedure called vein mapping. Vein mapping is a duplex ultrasound image of the upper extremity veins to determine whether the veins are suitable for a fistula, the veins have to be large enough with an upper arm vein diameter of ≥ 2.0 mm. The vein mapping is considered standard of care as part of the pre-operative evaluation for vascular access creation. Potential subjects will have their duplex ultrasound imaging pre-screened to determine whether study anatomical suitability has been met. The vascular surgeons will make the final determin…
Eligibility
- Age range
- 18–99 years
- Sex
- All
- Healthy volunteers
- No
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, tar…
Interventions
- DeviceendoAVF
The device will be used according to manufactures instructions and medical facilities standard of care. EndoAVF has a high likelihood of requiring additional procedures that would not have been required if they had undergone surgAVF.
- ProceduresurgAVF
The surgAAVF procedure will be done according to the medical facilities standard of care. SurgAVF can also require additional procedures to help with the fistula being useable.
Locations (2)
- UCLA Division of Vascular and Endovascular Surgery ClinicLos Angeles, California
- University of Pittsburgh Medical CenterPittsburgh, Pennsylvania