Comparing Surgical and Endovascular Arteriovenous Fistula Creation

NCT05654103 | Recruiting DMC FDA Device

• 2 other identifiers: IRB#22-0014441R01DK132422
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

End Stage Renal Disease on Dialysis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Physiologically mature fistula

  flow ≥ 500 ml/min and internal diameter \>0.5 cm

  6 months postoperatively

Secondary Outcomes (6)

• clinically mature

  6 months

• primary patency

  6 months

• secondary patency

  6 months

• functional patency

  6 months

• Number of interventions to achieve physiologic maturation

  6 months

Study Arms (2)

surgAVF

ACTIVE COMPARATOR

Participant will undergo fistula creation through surgical means, which requires undergoing general anesthesia and opening the skin to create the fistula.

Procedure: surgAVF

endoAVF

ACTIVE COMPARATOR

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.

Device: endoAVF

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.

Also known as: endovascular AVF

endoAVF

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.

Also known as: surgical AVF

surgAVF

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• Target vein diameter ≥ 2.0 mm, target artery diameter ≥ 2.0 mm, and ≤ 2 mm between target artery and vein.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Los Angeles: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (2)

UCLA Division of Vascular and Endovascular Surgery Clinic

Los Angeles, California, 90095, United States

RECRUITING

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15231, United States

RECRUITING

Related Publications (57)

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MeSH Terms

Conditions

Arteriovenous Fistula; Fistula; Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Fistula; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes

Study Officials

• Karen Woo, MD, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kate Horiuchi, MPH

CONTACT

310-267-1039; khoriuchi@mednet.ucla.edu

Jenny Lester, MPH

CONTACT

310-794-9728; Jlester@mednet.ucla.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery at the David Geffen School of Medicine at UCLA

Model Details: Randomized controlled trial where participants are assigned to receive a fistula created through surgery (open the skin) or endovascular surgery (through the skin). There is the option to not join the randomized portion and instead join a registry that will track the outcome of a participants fistula.

Study Record Dates

• First Submitted: December 8, 2022
• First Posted: December 16, 2022
• Study Start: November 20, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: October 29, 2025

Record last verified: 2025-10

Locations

US (2)