Actively Recruiting
SAVE-FistulaS: the SelfWrap-Assisted ArterioVEnous Fistulas Study
Led by VenoStent · Updated on 2026-02-17
600
Participants Needed
28
Research Sites
308 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a prospective, randomized, multi-center clinical trial for chronic kidney disease (CKD) patients referred for creation of a new arteriovenous fistula (AVF) in order to assess the safety and effectiveness of SelfWrap, a bioabsorbable perivascular wrap.
CONDITIONS
Official Title
SAVE-FistulaS: the SelfWrap-Assisted ArterioVEnous Fistulas Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age of at least 18 years
- Referred for creation of a new AVF
- Willing and able to comply with study requirements, communicate with the study team, and attend follow up visits over a period of 36 months
You will not qualify if you...
- Planned index procedure to revise or repair an existing fistula
- Target artery inner diameter less than 2.0 mm by ultrasound under tourniquet and anesthesia
- Target vein inner diameter less than 2.0 mm by ultrasound under tourniquet and anesthesia
- Significant (at least 50%) stenosis at the target vein on the side of surgery
- Known central venous stenosis of at least 50% on the side of surgery
- Presence of a stent or stent graft within the access circuit
- Known or suspected coagulation disorder that poses risk for AVF creation
- Known or suspected active infection at time of surgery
- Congestive heart failure NYHA class 4
- Prior steal on the side of surgery
- Enrolled in another investigational drug, device, or biological study, or previously enrolled in this study
- Life expectancy less than 12 months
- Expected to undergo kidney transplant surgery within 6 months of enrollment
- Expected to undergo home hemodialysis
- Females of childbearing potential without documented current negative pregnancy test at screening
- Presence of comorbid condition that may confound safety and efficacy data
- Unwillingness or inability to give consent or comply with follow up
- Any health condition interfering with safety or compliance per Investigator's opinion
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 28 locations
1
AKDHC Bullhead City
Bullhead City, Arizona, United States, 86442
Actively Recruiting
2
AKDHC Marana Surgery Center
Marana, Arizona, United States, 85658
Actively Recruiting
3
Arizona Kidney Disease & Hypertension Centers (AKDHC) Phoenix Surgery Center
Phoenix, Arizona, United States, 85012
Actively Recruiting
4
Banner University Medical Center
Tucson, Arizona, United States, 85724
Actively Recruiting
5
Orange County Vascular Access Center
Garden Grove, California, United States, 92840
Actively Recruiting
6
Tallahassee Research Institute
Tallahassee, Florida, United States, 32308
Actively Recruiting
7
Lutheran Medical Group
Fort Wayne, Indiana, United States, 46804
Actively Recruiting
8
Surgical Associates of Lexington
Lexington, Kentucky, United States, 40503
Actively Recruiting
9
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
10
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
11
University of Missouri
Columbia, Missouri, United States, 65212
Actively Recruiting
12
Saint Louis University
St Louis, Missouri, United States, 63104
Actively Recruiting
13
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
14
Northwell Health
Lake Success, New York, United States, 11042
Actively Recruiting
15
Surgical Specialists of Charlotte, P.A.
Charlotte, North Carolina, United States, 28226
Actively Recruiting
16
WakeMed
Raleigh, North Carolina, United States, 27610
Actively Recruiting
17
MUSC Charleston
Charleston, South Carolina, United States, 29425
Actively Recruiting
18
Vascular Care of South Carolina
Columbia, South Carolina, United States, 29203
Actively Recruiting
19
MUSC Black River
Florence, South Carolina, United States, 29505
Actively Recruiting
20
Prisma Health
Greenville, South Carolina, United States, 29615
Actively Recruiting
21
Medical University of South Carolina (MUSC) Orangeburg / Dialysis Access Institute
Orangeburg, South Carolina, United States, 29118
Actively Recruiting
22
Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States, 29650
Actively Recruiting
23
James Eric Gardner, MD, PC
Memphis, Tennessee, United States, 38115
Actively Recruiting
24
Saint David's HealthCare Partnership, L.P., LLP
Austin, Texas, United States, 78701
Actively Recruiting
25
A&V Doctors PLLC
El Paso, Texas, United States, 79912
Actively Recruiting
26
Houston Methodist Research Institute
Houston, Texas, United States, 77030
Actively Recruiting
27
Upper Valley Dialysis Access Center, LLC
Mission, Texas, United States, 78572
Actively Recruiting
28
Houston Methodist Research Institute (Sugar Land)
Sugar Land, Texas, United States, 77479
Actively Recruiting
Research Team
M
Mark Barakat, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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