SAVE-FistulaS: the SelfWrap-Assisted ArterioVEnous Fistulas Study

Recruiting now · Not applicable

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

In brief

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.

Key facts

Study ID

NCT06001827

Run by

VenoStent

People needed

600

Starts

2024-01-03

Expected to finish

2029-12-01

Last updated by the study team

2026-02-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Planned index procedure to revise or repair an existing fistula
• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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