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SAVE-FistulaS: the SelfWrap-Assisted ArterioVEnous Fistulas Study

NCT06001827

This study is recruiting at 28 US sites in 13 states, according to its ClinicalTrials.gov record last updated .

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.

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

  • Chronic Kidney Diseases
  • End Stage Renal Disease
  • Arteriovenous Fistula
  • Hemodialysis Access Failure
  • ESRD
  • Vascular Access Complication
  • Renal Failure
  • Catheter Complications
  • Catheter Dysfunction
  • Renal Insufficiency

Eligibility basics and study details

Study type
Interventional
Phase
Not applicable
Ages
18 years and older
Sex
All
Healthy volunteers
Not accepted
Sponsor
VenoStent
Last updated on ClinicalTrials.gov
February 17, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites

Arizona · 4

  • AKDHC Bullhead City · Bullhead City, AZ
  • AKDHC Marana Surgery Center · Marana, AZ
  • Arizona Kidney Disease & Hypertension Centers (AKDHC) Phoenix Surgery Center · Phoenix, AZ
  • Banner University Medical Center · Tucson, AZ

California · 1

  • Orange County Vascular Access Center · Garden Grove, CA

Florida · 1

  • Tallahassee Research Institute · Tallahassee, FL

Indiana · 1

  • Lutheran Medical Group · Fort Wayne, IN

Kentucky · 1

  • Surgical Associates of Lexington · Lexington, KY

Massachusetts · 1

  • Brigham and Women's Hospital · Boston, MA

Minnesota · 1

  • Mayo Clinic · Rochester, MN

Missouri · 3

  • University of Missouri · Columbia, MO
  • Saint Louis University · St Louis, MO
  • Washington University School of Medicine · St Louis, MO

New York · 1

  • Northwell Health · Lake Success, NY

North Carolina · 2

  • Surgical Specialists of Charlotte, P.A. · Charlotte, NC
  • WakeMed · Raleigh, NC

South Carolina · 6

  • MUSC Charleston · Charleston, SC
  • Vascular Care of South Carolina · Columbia, SC
  • MUSC Black River · Florence, SC
  • Prisma Health · Greenville, SC
  • Medical University of South Carolina (MUSC) Orangeburg / Dialysis Access Institute · Orangeburg, SC
  • Spartanburg Regional Medical Center · Spartanburg, SC

Tennessee · 1

  • James Eric Gardner, MD, PC · Memphis, TN

Texas · 5

  • Saint David's HealthCare Partnership, L.P., LLP · Austin, TX
  • A&V Doctors PLLC · El Paso, TX
  • Houston Methodist Research Institute · Houston, TX
  • Upper Valley Dialysis Access Center, LLC · Mission, TX
  • Houston Methodist Research Institute (Sugar Land) · Sugar Land, TX

Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.