AV Graft vs. Surgical Fistula for Kidney Failure
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment AV Graft, Arteriovenous Graft, AV Graft, Vascular Graft, Surgical Intervention for Creation of a Fistula, Arteriovenous Fistula Creation, AV Fistula Surgery, Surgical Intervention for Creation of a Fistula for kidney failure?
Recent studies suggest that in older adults with end-stage kidney disease, arteriovenous grafts (AVGs) might be a better option than arteriovenous fistulas (AVFs) for hemodialysis, although more evidence is needed to confirm this. AVFs have traditionally been preferred, but AVGs may offer advantages in certain patient groups.12345
Is the surgical creation of an arteriovenous fistula or graft generally safe for humans?
How does the AV Graft or Surgical Fistula treatment for kidney failure differ from other treatments?
The AV Graft and Surgical Fistula treatments are unique because they provide a long-term solution for vascular access in hemodialysis, which is crucial for patients with end-stage kidney disease. While AV Fistulas are traditionally preferred for their durability, recent studies suggest that AV Grafts might be a better option for older adults, offering a potentially more suitable alternative depending on the patient's age and condition.13101112
What is the purpose of this trial?
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
Research Team
Michael Allon, MD
Principal Investigator
University of Alabama at Birmingham
Mariana Murea, MD
Principal Investigator
Wake Forest Health Sciences
Matthew P Goldman, MD
Principal Investigator
Wake Forest University Health Sciences
Eligibility Criteria
This trial is for older adults aged 60 or above with end-stage kidney disease on hemodialysis, specifically those using a central venous catheter and having cardiovascular disease, peripheral vascular disease, or diabetes. Candidates must be deemed suitable for AV access surgery by their surgeon and referred by a nephrologist. Exclusions include severe cardiac conditions, anticipated kidney transplant within the year, or plans to switch to peritoneal dialysis.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo surgical placement of either a fistula or graft for permanent hemodialysis access
Follow-up
Participants are monitored for safety, effectiveness, and satisfaction with vascular access
Outcome Assessment
Assessment of catheter-free dialysis days, infections, and patient-reported outcomes
Treatment Details
Interventions
- AV Graft
- Surgical Intervention for Creation of a Fistula
AV Graft is already approved in United States, European Union for the following indications:
- End-stage renal disease (ESRD)
- Hemodialysis access
- Chronic kidney disease
- Renal failure requiring dialysis
Find a Clinic Near You
Who Is Running the Clinical Trial?
Wake Forest University Health Sciences
Lead Sponsor
National Institute on Aging (NIA)
Collaborator