๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-02-12

SAVE-FistulaS: the SelfWrap-Assisted ArterioVEnous Fistulas Study (NCT06001827)

๐ŸŸข Recruiting Observational / Diagnostic โš™๏ธ Medical Device Protocol Sponsor: VenoStent

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: AKDHC Bullhead City โ€” Bullhead City, Arizona

Age range: 18 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (28 Sites)

Showing the first 25 of 28 sites.

  • AKDHC Bullhead City โ€” Bullhead City, Arizona
  • AKDHC Marana Surgery Center โ€” Marana, Arizona
  • Arizona Kidney Disease & Hypertension Centers (AKDHC) Phoenix Surgery Center โ€” Phoenix, Arizona
  • Banner University Medical Center โ€” Tucson, Arizona
  • Orange County Vascular Access Center โ€” Garden Grove, California
  • Tallahassee Research Institute โ€” Tallahassee, Florida
  • Lutheran Medical Group โ€” Fort Wayne, Indiana
  • Surgical Associates of Lexington โ€” Lexington, Kentucky
  • Brigham and Women's Hospital โ€” Boston, Massachusetts
  • Mayo Clinic โ€” Rochester, Minnesota
  • University of Missouri โ€” Columbia, Missouri
  • Saint Louis University โ€” St Louis, Missouri
  • Washington University School of Medicine โ€” St Louis, Missouri
  • Northwell Health โ€” Lake Success, New York
  • Surgical Specialists of Charlotte, P.A. โ€” Charlotte, North Carolina
  • WakeMed โ€” Raleigh, North Carolina
  • MUSC Charleston โ€” Charleston, South Carolina
  • Vascular Care of South Carolina โ€” Columbia, South Carolina
  • MUSC Black River โ€” Florence, South Carolina
  • Prisma Health โ€” Greenville, South Carolina
  • Medical University of South Carolina (MUSC) Orangeburg / Dialysis Access Institute โ€” Orangeburg, South Carolina
  • Spartanburg Regional Medical Center โ€” Spartanburg, South Carolina
  • James Eric Gardner, MD, PC โ€” Memphis, Tennessee
  • Saint David's HealthCare Partnership, L.P., LLP โ€” Austin, Texas
  • A&V Doctors PLLC โ€” El Paso, Texas

๐Ÿ“ž Contact the Study Coordinator

Phone: (832) 429-5362

Email: mark.barakat@venostent.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—