SelfWrap for Creating Arteriovenous Fistulas

SAVE-FistulaS: the SelfWrap-Assisted ArterioVEnous Fistulas Study

Recruiting N/A Interventional Study
Chronic Kidney Diseases End Stage Renal Disease Arteriovenous Fistula Hemodialysis Access Failure ESRD Vascular Access Complication Renal Failure Catheter Complications Catheter Dysfunction Renal Insufficiency
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
600 (estimated)
Sponsor
VenoStent · Industry
Who this trial is looking for

This trial is looking for adults with chronic kidney disease who need a new arteriovenous fistula for dialysis. Participants will receive a special wrap during the procedure and will follow up with the study team for 36 months.

Are You a Good Fit for This Trial?
Rules you out Congestive heart failure NYHA class 4

You may be able to join if

  • I am at least 18 years old.
  • I have been referred for a new arteriovenous fistula.
  • I can follow study requirements and attend follow-up visits.

You may not be able to join if

  • I am having surgery to fix an existing fistula.
  • The target artery is less than 2.0 mm in diameter.
  • The target vein is less than 2.0 mm in diameter.
  • I have significant narrowing in the target vein.
  • I have central venous stenosis of at least 50%.
  • I have a stent in the access circuit.
  • I have an active infection at the time of surgery.
  • I have a life expectancy of less than 12 months.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

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About This Trial

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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Planned index procedure to revise or repair an ex…
Contacts

Mark Barakat, MD

(832) 429-5362

mark.barakat@venostent.com

CONTACT