SAVE-FistulaS: the SelfWrap-Assisted ArterioVEnous Fistulas Study
Status: Recruiting
Location: See all (22) locations...
Intervention Type: Device, Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Arizona
AKDHC Bullhead City
RECRUITING
Bullhead City
AKDHC Marana Surgery Center
RECRUITING
Marana
Arizona Kidney Disease & Hypertension Centers (AKDHC) Phoenix Surgery Center
RECRUITING
Phoenix
Banner University Medical Center
RECRUITING
Tucson
Florida
Tallahassee Research Institute
RECRUITING
Tallahassee
Indiana
Lutheran Medical Group
RECRUITING
Fort Wayne
Kentucky
Surgical Associates of Lexington
RECRUITING
Lexington
Massachusetts
Brigham and Women's Hospital
RECRUITING
Boston
Missouri
University of Missouri
RECRUITING
Columbia
Saint Louis University
RECRUITING
St Louis
Washington University School of Medicine
RECRUITING
St Louis
North Carolina
Surgical Specialists of Charlotte, P.A.
RECRUITING
Charlotte
WakeMed
RECRUITING
Raleigh
New York
Northwell Health
RECRUITING
Lake Success
South Carolina
MUSC Charleston
RECRUITING
Charleston
MUSC Black River
RECRUITING
Florence
Prisma Health
RECRUITING
Greenville
Medical University of South Carolina (MUSC) Orangeburg / Dialysis Access Institute
RECRUITING
Orangeburg
Spartanburg Regional Medical Center
RECRUITING
Spartanburg
Texas
Saint David's HealthCare Partnership, L.P., LLP
RECRUITING
Austin
Houston Methodist Research Institute
RECRUITING
Houston
Houston Methodist Research Institute (Sugar Land)
RECRUITING
Sugar Land
Contact Information
Primary
Mark Barakat, MD
mark.barakat@venostent.com
(832) 429-5362
Time Frame
Start Date: 2024-01-03
Estimated Completion Date: 2029-03
Participants
Target number of participants: 200
Treatments
Experimental: Treatment Arm
Treated with SelfWrap Bioabsorbable Perivascular Wrap during AVF creation surgery
Sham_comparator: Control Arm
AVF creation surgery without any intervention (untreated AVF control, or standard of care)
Related Therapeutic Areas
Sponsors
Leads: VenoStent