NCT04646226

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 103 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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

Detailed description

This study will determine the effects of arteriovenous (AV) fistula versus AV graft vascular access strategy on the rate of catheter-free dialysis days and access-related infections - costs associated with the dialysis vascular access - patient-reported satisfaction with different processes of vascular access care (catheter, fistula, or graft) - and the relationship between preoperative functional status and incidence of fistula or graft maturation failure

Conditions

• End-Stage Kidney Disease
• Hemodialysis Complication

Interventions

Type	Name	Description
DEVICE	AV graft	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)
PROCEDURE	surgical intervention for creation of a fistula	The purpose of the surgery is to connect a large vein in the arm to a nearby artery directly (fistula surgery)

Timeline

• Start date: 2022-08-18
• Primary completion: 2027-06-30
• Completion: 2027-08-31
• First posted: 2020-11-27
• Last updated: 2025-06-27

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated device study