Actively Recruiting
SAVE-FistulaS: the SelfWrap-Assisted ArterioVEnous Fistulas Study
Led by VenoStent · Updated on 2026-02-17
600
Participants Needed
28
Research Sites
130 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of SelfWrap, a bioabsorbable perivascular wrap, in patients with chronic kidney disease (CKD) who are referred for creation of a new arteriovenous fistula (AVF). This multi-center, prospective, randomized, double-arm, single-blind clinical trial involves about 600 participants across up to 30 sites. The purpose is to compare SelfWrap-assisted AVF creation with the standard surgical procedure without any additional intervention over a 36-month follow-up period. Participants are randomly assigned to one of two groups: one receiving the SelfWrap device during AVF creation surgery, and the other undergoing the usual AVF surgery without intervention as a control group. The SelfWrap device offers mechanical support intended to improve the maturation and patency of the fistula. The trial follows participants for 36 months after surgery to monitor outcomes. During the study, participants will undergo assessments to measure unassisted maturation of the AVF at up to 6 months and monitor freedom from access-related adverse events through 30 days. Researchers will evaluate safety and effectiveness through these primary outcome measures. Participants are expected to comply with study requirements and attend follow-up visits throughout the 36-month period to allow comprehensive evaluation of the device's impact and any complications.
CONDITIONS
Brief 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 arteriovenous fistula (AVF)
- Willing and able to comply with study requirements, communicate with the study team, and attend follow-up visits over 36 months
You will not qualify if you...
- Planned procedure to revise or repair an existing fistula
- Target artery inner diameter less than 2.0 mm measured by ultrasound
- Target vein inner diameter less than 2.0 mm measured by ultrasound
- Significant stenosis (at least 50%) at the target vein on the surgery side
- Known central venous stenosis of at least 50% on the surgery side
- Presence of a stent or stent graft within the access circuit
- Known or suspected coagulation disorder posing high risk for AVF creation
- Known or suspected active infection at time of surgery
- Congestive heart failure NYHA class 4
- Prior steal syndrome on the surgery side
- Currently enrolled or previously enrolled in another investigational drug, device, or biological study
- Life expectancy less than 12 months
- Expected kidney transplant within 6 months of enrollment
- Expected to undergo home hemodialysis
- Females of childbearing potential without a documented current negative pregnancy test
- 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 as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo arteriovenous fistula (AVF) creation surgery. Those in the treatment group receive the SelfWrap Bioabsorbable Perivascular Wrap during surgery, while others receive standard surgery without the wrap.
1 surgery visit (in-person)
Duration - Up to 30 days
Participants are followed to assess maturation and patency of the AVF and monitor for access-related adverse events.
Approximately 2 to 3 visits within 30 days
Duration - Up to 6 months
Participants are monitored while their AVF matures and functions, receiving ongoing assessments related to the device or standard care.
Regular visits during the 6 months for assessments
Duration - Up to 36 months
Participants continue to be followed for up to 36 months to evaluate long-term outcomes and AVF patency.
Periodic follow-up visits over 36 months
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
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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