SAVE-FistulaS: the SelfWrap-Assisted ArterioVEnous Fistulas Study
SAVE-FistulaS
1 other identifier
interventional
600
1 country
28
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2024
Longer than P75 for not_applicable
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 14, 2023
CompletedFirst Posted
Study publicly available on registry
August 21, 2023
CompletedStudy Start
First participant enrolled
January 3, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2029
February 17, 2026
February 1, 2026
3.4 years
August 14, 2023
February 12, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Unassisted Maturation by 180 days
A participant who is either 1) on hemodialysis on or before day 150 and the AVF has been cannulated with two needles for at least 75% of dialysis sessions within any 4 consecutive week period to achieve the prescribed dialysis by the 180 day follow up, and did not require any facilitative endovascular or surgical intervention to achieve this, or 2) is not on hemodialysis on or before day 150, but ultrasound measurements by the 180 day follow up indicate a proximal arterial flow rate of at least 500 mL/min and a vein inner diameter of at least 5.0 mm at 5 - 8 cm from the anastomosis, and did not require any facilitative endovascular or surgical intervention through the 180 day follow up.
Assessed at up to 6 months
Freedom from access-related adverse events through 30 days
Freedom from access-related adverse events through 30 days
Assessed through 30 days
Study Arms (2)
Treatment Arm
EXPERIMENTALTreated with SelfWrap Bioabsorbable Perivascular Wrap during AVF creation surgery
Control Arm
SHAM COMPARATORAVF creation surgery without any intervention (untreated AVF control, or standard of care)
Interventions
SelfWrap is applied during arteriovenous fistula (AVF) creation surgery. It provides mechanical support to improve maturation and patency of AVFs.
AVF creation surgery without any intervention
Eligibility Criteria
You may qualify if:
- 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 may not qualify if:
- Planned index procedure to revise or repair an existing fistula
- Target artery inner diameter \< 2.0 mm, as measured by ultrasound while the target arm is under tourniquet pressure and anesthesia
- Target vein inner diameter \< 2.0 mm, as measured by ultrasound while the target arm is under tourniquet pressure and anesthesia
- Significant (at least 50%) stenosis at the target vein on the side of surgery (between the planned anastomosis site and the axillary vein), as diagnosed by preoperative ultrasound
- Known central venous stenosis of at least 50% on the side of surgery
- Presence of a stent or a stent graft within the access circuit
- Known or suspected coagulation disorder that, in the opinion of the Investigator, puts too much risk on the patient for AVF creation
- Known or suspected active infection at the 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 was 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 (premenopausal and not surgically sterile) without documented current negative pregnancy test at screening
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- VenoStentlead
Study Sites (28)
AKDHC Bullhead City
Bullhead City, Arizona, 86442, United States
AKDHC Marana Surgery Center
Marana, Arizona, 85658, United States
Arizona Kidney Disease & Hypertension Centers (AKDHC) Phoenix Surgery Center
Phoenix, Arizona, 85012, United States
Banner University Medical Center
Tucson, Arizona, 85724, United States
Orange County Vascular Access Center
Garden Grove, California, 92840, United States
Tallahassee Research Institute
Tallahassee, Florida, 32308, United States
Lutheran Medical Group
Fort Wayne, Indiana, 46804, United States
Surgical Associates of Lexington
Lexington, Kentucky, 40503, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
University of Missouri
Columbia, Missouri, 65212, United States
Saint Louis University
St Louis, Missouri, 63104, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Northwell Health
Lake Success, New York, 11042, United States
Surgical Specialists of Charlotte, P.A.
Charlotte, North Carolina, 28226, United States
WakeMed
Raleigh, North Carolina, 27610, United States
MUSC Charleston
Charleston, South Carolina, 29425, United States
Vascular Care of South Carolina
Columbia, South Carolina, 29203, United States
MUSC Black River
Florence, South Carolina, 29505, United States
Prisma Health
Greenville, South Carolina, 29615, United States
Medical University of South Carolina (MUSC) Orangeburg / Dialysis Access Institute
Orangeburg, South Carolina, 29118, United States
Spartanburg Regional Medical Center
Spartanburg, South Carolina, 29650, United States
James Eric Gardner, MD, PC
Memphis, Tennessee, 38115, United States
Saint David's HealthCare Partnership, L.P., LLP
Austin, Texas, 78701, United States
A&V Doctors PLLC
El Paso, Texas, 79912, United States
Houston Methodist Research Institute
Houston, Texas, 77030, United States
Upper Valley Dialysis Access Center, LLC
Mission, Texas, 78572, United States
Houston Methodist Research Institute (Sugar Land)
Sugar Land, Texas, 77479, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Timothy Boire, PhD
VenoStent, Inc.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 14, 2023
First Posted
August 21, 2023
Study Start
January 3, 2024
Primary Completion (Estimated)
June 1, 2027
Study Completion (Estimated)
December 1, 2029
Last Updated
February 17, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share