SAVE-FistulaS: the SelfWrap-Assisted ArterioVEnous Fistulas Study
NCT ID: NCT06001827
Last Updated: 2025-04-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
200 participants
INTERVENTIONAL
2024-01-03
2029-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Treatment Arm
Treated with SelfWrap Bioabsorbable Perivascular Wrap during AVF creation surgery
SelfWrap Bioabsorbable Perivascular Wrap
SelfWrap is applied during arteriovenous fistula (AVF) creation surgery. It provides mechanical support to improve maturation and patency of AVFs.
Control Arm
AVF creation surgery without any intervention (untreated AVF control, or standard of care)
Untreated AVF Control
AVF creation surgery without any intervention
Interventions
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SelfWrap Bioabsorbable Perivascular Wrap
SelfWrap is applied during arteriovenous fistula (AVF) creation surgery. It provides mechanical support to improve maturation and patency of AVFs.
Untreated AVF Control
AVF creation surgery without any intervention
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
* Presence of a comorbid condition that, in the opinion of the Investigator, may significantly confound the collection of safety and efficacy data in this study
* Unwillingness or inability to give consent and/or comply with the study follow up schedule
* Any health condition, which in the opinion of the Investigator, would interfere with the safety of the participant or the participant's ability to comply with the study.
18 Years
ALL
No
Sponsors
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VenoStent
INDUSTRY
Responsible Party
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Principal Investigators
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Timothy Boire, PhD
Role: STUDY_DIRECTOR
VenoStent, Inc.
Locations
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AKDHC Bullhead City
Bullhead City, Arizona, United States
AKDHC Marana Surgery Center
Marana, Arizona, United States
Arizona Kidney Disease & Hypertension Centers (AKDHC) Phoenix Surgery Center
Phoenix, Arizona, United States
Banner University Medical Center
Tucson, Arizona, United States
Tallahassee Research Institute
Tallahassee, Florida, United States
Lutheran Medical Group
Fort Wayne, Indiana, United States
Surgical Associates of Lexington
Lexington, Kentucky, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
University of Missouri
Columbia, Missouri, United States
Saint Louis University
St Louis, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Northwell Health
Lake Success, New York, United States
Surgical Specialists of Charlotte, P.A.
Charlotte, North Carolina, United States
WakeMed
Raleigh, North Carolina, United States
MUSC Charleston
Charleston, South Carolina, United States
MUSC Black River
Florence, South Carolina, United States
Prisma Health
Greenville, South Carolina, United States
Medical University of South Carolina (MUSC) Orangeburg / Dialysis Access Institute
Orangeburg, South Carolina, United States
Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States
Saint David's HealthCare Partnership, L.P., LLP
Austin, Texas, United States
Houston Methodist Research Institute
Houston, Texas, United States
Houston Methodist Research Institute (Sugar Land)
Sugar Land, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Sharon Eichman
Role: backup
Rhonda Norton
Role: backup
Related Links
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SAVE-FistulaS website
VenoStent website
Other Identifiers
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VENO-CIP002
Identifier Type: -
Identifier Source: org_study_id
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