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SelfWrap-Assisted Arteriovenous Fistulas for Chronic Kidney Disease

SAVE-FistulaS: the SelfWrap-Assisted ArterioVEnous Fistulas Study

Not applicable Interventional VenoStent · NCT06001827

This study is testing if a new wrap called SelfWrap can make it safer and more effective for people with chronic kidney disease to have a new arteriovenous fistula created.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment600 (estimated)
Ages18 Years and up
SexAll
SponsorVenoStent Industry-sponsored
Locations28 sites (Bullhead City, Arizona and 27 other locations)
Trial IDNCT06001827 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and effectiveness of SelfWrap, a bioabsorbable perivascular wrap, in patients with chronic kidney disease who are undergoing the creation of a new arteriovenous fistula (AVF). It is a multi-center, prospective, randomized, double-arm, single-blind study involving approximately 200 participants across 25 investigational sites. Participants will be randomly assigned to receive either the SelfWrap treatment or standard of care, with follow-up assessments conducted over a period of 36 months.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 years or older who are referred for the creation of a new arteriovenous fistula.

Not a fit: Patients with existing fistula revisions, significant stenosis, or coagulation disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve the success rates of arteriovenous fistulas, leading to better hemodialysis access for patients with chronic kidney disease.

How similar studies have performed: While this approach is innovative, similar studies have not been widely reported, indicating a novel exploration in this area.

Eligibility criteria

Show full inclusion / exclusion 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 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 this trial is running

Bullhead City, Arizona and 27 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Chronic Kidney DiseasesEnd Stage Renal DiseaseArteriovenous FistulaHemodialysis Access FailureESRDVascular Access ComplicationRenal FailureCatheter Complications
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.