RECRUITING

Comparing Surgical and Endovascular Arteriovenous Fistula Creation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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 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.

Official Title

Randomized Controlled Trial Comparing EndoAVF Versus SurgAVF

Quick Facts

Study Start:2024-11-20
Study Completion:2027-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05654103

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 99 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * ESKD patients aged ≥ 18 who have chosen hemodialysis as their renal replacement option.
  2. * Ability to give consent to participate in a research study.
  3. * Upper arm vein diameter of ≥ 2.0 mm.
  1. * People under the age of 18.
  2. * Inability to understand the consent process and/or give consent.
  3. * Upper arm vein diameter less than 2.0 mm making them unsuitable to receive an surgAVF AND endoAVF.
  4. * 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.
  5. * Currently incarcerated individuals.
  6. * Currently pregnant or planning to get pregnant within the next 6 months.
  7. * Individuals who choose peritoneal dialysis over hemodialysis and/or undergoing a kidney transplant within 6 months of randomization.

Contacts and Locations

Study Contact

Kate Horiuchi, MPH
CONTACT
310-267-1039
khoriuchi@mednet.ucla.edu
Jenny Lester, MPH
CONTACT
310-794-9728
Jlester@mednet.ucla.edu

Principal Investigator

Karen Woo, MD, PhD
PRINCIPAL_INVESTIGATOR
University of California, Los Angeles

Study Locations (Sites)

UCLA Division of Vascular and Endovascular Surgery Clinic
Los Angeles, California, 90095
United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15231
United States

Collaborators and Investigators

Sponsor: University of California, Los Angeles

  • Karen Woo, MD, PhD, PRINCIPAL_INVESTIGATOR, University of California, Los Angeles

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-20
Study Completion Date2027-08-31

Study Record Updates

Study Start Date2024-11-20
Study Completion Date2027-08-31

Terms related to this study

Keywords Provided by Researchers

  • hemodialysis
  • arteriovenous fistula
  • fistula
  • endoAVF
  • End Stage Renal Disease

Additional Relevant MeSH Terms

  • End Stage Renal Disease on Dialysis