The Arteriovenous Vascular (AV) ACCESS Trial

NCT04646226 | Active Not Recruiting DMC FDA Device

• 2 other identifiers: IRB000695931R01AG071803-01
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 7

Brief Summary

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

Conditions

End-Stage Kidney Disease; Hemodialysis Complication

Keywords

Hemodialysis; End-Stage Kidney Disease; central venous catheters; arteriovenous fistula [AVF]; arteriovenous graft [AVG]; Arteriovenous Vascular Access

Outcome Measures

Primary Outcomes (2)

• Number of Catheter-free dialysis days

  Determine the effects of arteriovenous (AV) fistula vs. AV graft vascular access strategy on the rate of catheter-free dialysis days

  Until death, collected up to 4 years

• Number of Infections

  Access-related infections - catheter-related blood-stream infection, with or without sepsis, requiring hospitalization for treatment

  Until death, collected up to 4 years

Secondary Outcomes (6)

• Vascular access-related cost per patient-year

  Year 2

• Incidence rate of study fistula/graft primary maturation failure

  hour 72, Month 3, Month 6, and Year 4

• Time to successful fistula/graft access cannulation

  Until death, collected up to 4 years

• Incidence rate of fistula/graft access hemodialysis suitability

  Month 6

• Functional patency of study fistula or graft access

  Until death, collected up to 4 years

Other Outcomes (8)

• Vascular Access Score

  baseline and Months 6 and 12

• SUPPORT Trial questionnaire

  baseline and Months 6, and 12

• Decision Regret Scale

  Months 6, and 12

Study Arms (2)

fistula surgically placed

EXPERIMENTAL

Randomized group to have surgically placed fistula for permanent hemodialysis access

Procedure: surgical intervention for creation of a fistula

graft surgically placed

ACTIVE COMPARATOR

Randomized group to have surgically placed graft for permanent hemodialysis access

Device: AV graft

Interventions

AV graft DEVICE

The purpose of the surgery is to connect a large vein in the arm to a nearby artery indirectly by inserting a graft material (graft surgery)

graft surgically placed

surgical intervention for creation of a fistula PROCEDURE

The purpose of the surgery is to connect a large vein in the arm to a nearby artery directly (fistula surgery)

fistula surgically placed

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Known or suspected central vein stenosis or vascular obstruction on the side of planned study access creation, unless corrected prior to randomization
• Planned arteriovenous fistula creation by means other than suture or vascular anastomotic clips (e.g. endovascular surgery or other anastomotic creation devices)
• Anticipated kidney transplant within 12 months
• 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
• A condition in which, in the opinion of the site PI renders the patient not a good candidate for study participation.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Institute on Aging (NIA): collaborator

Study Sites (7)

University of Alabama at Birmingham School of Medicine

Birmingham, Alabama, 35487, United States

Location

UCLA

Los Angeles, California, 90095, United States

Location

Johns Hopkins School of Medicine

Baltimore, Maryland, 21205, United States

Location

Atrium Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

Prisma Health Upstate

Greenville, South Carolina, 29601, United States

Location

University of Tennessee Medical Center at Knoxville

Knoxville, Tennessee, 37920, United States

Location

University of Wisconsin School of Medicine and Public Health

Madison, Wisconsin, 53726, United States

Location

Related Publications (1)

• Murea M, Gardezi AI, Goldman MP, Hicks CW, Lee T, Middleton JP, Shingarev R, Vachharajani TJ, Woo K, Abdelnour LM, Bennett KM, Geetha D, Kirksey L, Southerland KW, Young CJ, Brown WM, Bahnson J, Chen H, Allon M. Study protocol of a randomized controlled trial of fistula vs. graft arteriovenous vascular access in older adults with end-stage kidney disease on hemodialysis: the AV access trial. BMC Nephrol. 2023 Feb 24;24(1):43. doi: 10.1186/s12882-023-03086-5.

  PMID: 36829135 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

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; Pathological Conditions, Signs and Symptoms

Study Officials

• Mariana Murea, MD

  Wake Forest Health Sciences

  PRINCIPAL INVESTIGATOR

• Matthew P Goldman, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

• Michael Allon, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Study will determine if placement of a graft access will be more effective at having access switched from catheter to using the graft; have fewer interventions on the graft access; have better arm function; have better self-sufficiency with daily activities; and better quality of life compared to those who receive a fistula - identify strategies that decrease dialysis access failure and improve quality of life

Study Record Dates

• First Submitted: November 20, 2020
• First Posted: November 27, 2020
• Study Start: August 18, 2022
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: June 27, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share

Locations

US (7)