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NCT04646226Active, not recruiting

The Arteriovenous Vascular (AV) ACCESS Trial

A Randomized Trial of Fistula vs. Graft Arteriovenous Vascular Access in Older Adults With End-Stage Kidney Disease on Hemodialysis

Source: ClinicalTrials.gov · Last updated 1 Jun 2026

Brief summary (registry, in English)

This study is to prospectively compare the effectiveness and safety of the two types of arteriovenous access placement (fistula or graft) in older adults with end stage kidney disease and multiple chronic conditions

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
103 (actual)
First submitted
20 Nov 2020
Start date
18 Aug 2022
Primary completion date
30 Jun 2027
Lead sponsor
Wake Forest University Health Sciences
NCT number
NCT04646226

What you commit to

  • Study type: Interventional
  • Participants enrolled: 103
  • From 18 Aug 2022 to the primary completion date, 30 Jun 2027
  • 7 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Known or suspected central vein stenosis or vascular obstruction on the side of planned study access creation, unless corrected prior to randomization
  • Anticipated kidney transplant within 12 months

Other illness

  • Planned arteriovenous fistula creation by means other than suture or vascular anastomotic clips (e.g. endovascular surgery or other anastomotic creation devices)
  • A condition in which, in the opinion of the site PI renders the patient not a good candidate for study participation.

Lab values

  • Severe cardiac disease defined as presence of either of the following three conditions: congestive heart failure with ejection fraction ≤ 20%, heart transplant, or ventricular assist device

Other

  • Anticipated conversion to peritoneal dialysis within 12 months
  • Anticipated transfer of nephrology care to a clinic outside the study participating centers within 12 months
  • Anticipated non-compliance with medical care based on physician judgment

Who the study is looking for

  • Age 60 years or older
  • End-stage kidney disease on hemodialysis via a central venous catheter
  • Hemodialysis is the long-term modality of treatment for end-stage kidney disease
  • Central venous catheter is the sole vascular access used for hemodialysis at the time of referral for arteriovenous access creation
  • Referred by patient's nephrologist for placement of arteriovenous access
  • At least one of the following comorbid conditions: cardiovascular disease, peripheral vascular disease, and/or diabetes mellitus
  • Medically and surgically eligible to undergo surgical placement of an arteriovenous access, deemed by the treating healthcare providers
  • Native vasculature deemed preoperatively to be suitable for surgical creation of either type of arteriovenous access (arteriovenous fistula or arteriovenous graft) in the opinion of the surgeon
  • Patient agreed to study participation and signed the informed consent

Age in the registry: 60 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (7)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Johns Hopkins School of Medicine
Coordinator of this site? Confirm its status
BaltimoreUnited StatesUnknown status
University of Alabama at Birmingham School of Medicine
Coordinator of this site? Confirm its status
BirminghamUnited StatesUnknown status
Prisma Health-Upstate
Coordinator of this site? Confirm its status
GreenvilleUnited StatesUnknown status
University of Tennessee Medical Center at Knoxville
Coordinator of this site? Confirm its status
KnoxvilleUnited StatesUnknown status
UCLA
Coordinator of this site? Confirm its status
Los AngelesUnited StatesUnknown status
University of Wisconsin School of Medicine and Public Health
Coordinator of this site? Confirm its status
MadisonUnited StatesUnknown status
Atrium Wake Forest Baptist Medical Center
Coordinator of this site? Confirm its status
Winston-SalemUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.