SAVE-FistulaS: the SelfWrap-Assisted ArterioVEnous Fistulas Study (NCT06001827)
๐ฉบ 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
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ 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
๐ 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.
๐ฐ 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.
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๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.