Comparing Surgical and Endovascular Arteriovenous Fistula Creation

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of California, Los Angeles
Study ID
NCT05654103
Status
Recruiting
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Conditions

  • End Stage Renal Disease on Dialysis

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • endoAVF — DEVICE
    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.
  • surgAVF — PROCEDURE
    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.

Study Details

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.

Key Dates

Start date
Nov 20, 2024
Status verified
Oct 2025
Primary completion
Dec 1, 2027
Completion
Jan 1, 2028

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: surgAVF
    Participant will undergo fistula creation through surgical means, which requires undergoing general anesthesia and opening the skin to create the fistula.
  • Active Comparator: endoAVF
    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.

Primary Outcome Measure

Physiologically mature fistula [ Time Frame: 6 months postoperatively ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
UCLA Division of Vascular and Endovascular Surgery ClinicLos AngelesCalifornia90095
Karen Woo, MD, PhD
[email protected]
310-825-5394
University of Pittsburgh Medical CenterPittsburghPennsylvania15231
Theodore Yuo, MD
[email protected]
412-623-8438

Find similar trials in Los Angeles, CA

By research site
UCLA Division of Vascular and Endovascular Surgery Clinic· Los Angeles, CAUniversity of Pittsburgh Medical Center· Pittsburgh, PA

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