RecruitingNot ApplicableNCT06001827

SAVE-FistulaS: the SelfWrap-Assisted ArterioVEnous Fistulas Study

Sponsor

VenoStent

Enrollment

600 participants

Start Date

Jan 3, 2024

Study Type

INTERVENTIONAL

Conditions

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

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (called SAVE-FistulaS) tests a new device called SelfWrap that is placed around a surgically created arteriovenous fistula (AVF) — the connection between an artery and vein in the arm used for dialysis — to help it mature and function better. **You may be eligible if...** - You are 18 years or older - You have been referred for creation of a brand-new AVF (not repair of an existing one) - Your blood vessels (both artery and vein at the surgery site) are large enough (at least 2 mm in diameter, measured by ultrasound) - You are willing and able to attend follow-up visits over 3 years **You may NOT be eligible if...** - You are having a revision or repair of an existing fistula (not creation of a new one) - Your target artery or vein is too small (under 2 mm) - You have significant narrowing or blockage in the vein between the planned site and your armpit - You have a known blockage in the large central veins of your chest Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICESelfWrap Bioabsorbable Perivascular Wrap

SelfWrap is applied during arteriovenous fistula (AVF) creation surgery. It provides mechanical support to improve maturation and patency of AVFs.

PROCEDUREUntreated AVF Control

AVF creation surgery without any intervention

Locations(28)

AKDHC Bullhead City

Bullhead City, Arizona, United States

AKDHC Marana Surgery Center

Marana, Arizona, United States

Arizona Kidney Disease & Hypertension Centers (AKDHC) Phoenix Surgery Center

Phoenix, Arizona, United States

Banner University Medical Center

Tucson, Arizona, United States

Orange County Vascular Access Center

Garden Grove, California, United States

Tallahassee Research Institute

Tallahassee, Florida, United States

Lutheran Medical Group

Fort Wayne, Indiana, United States

Surgical Associates of Lexington

Lexington, Kentucky, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Mayo Clinic

Rochester, Minnesota, United States

University of Missouri

Columbia, Missouri, United States

Saint Louis University

St Louis, Missouri, United States

Washington University School of Medicine

St Louis, Missouri, United States

Northwell Health

Lake Success, New York, United States

Surgical Specialists of Charlotte, P.A.

Charlotte, North Carolina, United States

WakeMed

Raleigh, North Carolina, United States

MUSC Charleston

Charleston, South Carolina, United States

Vascular Care of South Carolina

Columbia, South Carolina, United States

MUSC Black River

Florence, South Carolina, United States

Prisma Health

Greenville, South Carolina, United States

Medical University of South Carolina (MUSC) Orangeburg / Dialysis Access Institute

Orangeburg, South Carolina, United States

Spartanburg Regional Medical Center

Spartanburg, South Carolina, United States

James Eric Gardner, MD, PC

Memphis, Tennessee, United States

Saint David's HealthCare Partnership, L.P., LLP

Austin, Texas, United States

A&V Doctors PLLC

El Paso, Texas, United States

Houston Methodist Research Institute

Houston, Texas, United States

Upper Valley Dialysis Access Center, LLC

Mission, Texas, United States

Houston Methodist Research Institute (Sugar Land)

Sugar Land, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT06001827

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