About the TrialUpdates

SAVE-FistulaS Clinical Trial

About the Trial

VenoStent’s SAVE-FistulaS clinical trial is enrolling 200 participants

  • If your kidneys are failing, and your physician is referring you to undergo an arteriovenous fistula (AVF) creation surgery that connects an artery to a vein in your arm to allow for hemodialysis treatments, you may be eligible for this study.
  • AVFs often fail (50 – 60% of the time within the first year) due to the vein growing inwards. This results in a blockage of blood flow that is inadequate to support dialysis treatments through the AVF.
  • A primary reason why AVFs fail is because the vein is not built strong and elastic like an artery, and cannot withstand the 10x increase in pressure and flow that it experiences from the AVF creation surgery.
  • VenoStent’s SelfWrap has been bioengineered to address this problem with a wrap that goes around the vein-artery junction to provide mechanical support, essentially strengthening the vein so that it can adapt to its new high pressure, high flow environment.
Learn how SelfWrap works
Actively Enrolling Sites
  • Cardiothoracic and Vascular Surgeons

    1010 W 40th St., Austin, TX 78756ctvstexas.com
    Ryan Turley, MD
    Ryan Turley, MDPrincipal Investigator
    For more information contact:
  • Surgical Specialists of Charlotte, PA

    Jason Burgess, MD
    Jason Burgess, MDPrincipal Investigator
    For more information contact:
clinicaltrials.gov: NCT06001827

SelfWrap is currently in the research and development phase and is not available for sale in any country. Investigational device. Limited by federal law to investigational use.

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