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SAVE-FistulaS: SelfWrap for Arteriovenous Fistulas

This study is testing a device called SelfWrap Bioabsorbable Perivascular Wrap. It's for people with chronic kidney disease (CKD) who need a new arteriovenous fistula (AVF) for hemodialysis. An AVF is a connection made between an artery and a vein, usually in the arm, to create a strong blood vessel for dialysis. The SelfWrap is applied during AVF surgery to help the fistula mature and stay open. The study wants to see if SelfWrap is safe and effective compared to standard AVF surgery without the wrap. Success means the fistula matures well within 6 months and you don't have many access-related problems in the first 30 days. You can join if you are at least 18 years old, need a new AVF, and can attend follow-up visits for 36 months. The study status is currently unclear.

Study design
This is a randomized, multi-center study with about 600 participants. Participants will be randomly assigned to either receive the SelfWrap or standard AVF surgery without the wrap.
What's involved
You would have AVF creation surgery and attend follow-up visits for 36 months. You will need to communicate with the study team.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for a duration of 36 months after treatment.

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NCT06001827

SAVE-FistulaS: the SelfWrap-Assisted ArterioVEnous Fistulas Study

Recruiting
NAAges 18+InterventionalTreatment
VenoStent
~600 participants
Updated 2026-02-17 on ClinicalTrials.gov
What's tested:SelfWrap Bioabsorbable Perivascular WrapUntreated AVF Control

At a glance

Recruiting sites
28 of 28 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Unassisted Maturation by 180 days
Measured over Assessed at up to 6 months
+1 more outcome measured

Conditions

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

Explore related trials

Arteriovenous FistulaChronic Kidney DiseaseChronic Kidney Disease, Stage 5

Where it's being run

28 sites across 13 states
South Carolina6
Texas5
Arizona4
Missouri3
North Carolina2
California1
Florida1
Indiana1

Study leadership

  • Timothy Boire, PhD · STUDY_DIRECTOR · VenoStent, Inc.

Who to contact

Mark Barakat, MD
[email protected]
(832) 429-5362
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Unassisted Maturation by 180 daysAssessed at up to 6 months

    A participant who is either 1) on hemodialysis on or before day 150 and the AVF has been cannulated with two needles for at least 75% of dialysis sessions within any 4 consecutive week period to achieve the prescribed dialysis by the 180 day follow up, and did not require any facilitative endovascular or surgical intervention to achieve this, or 2) is not on hemodialysis on or before day 150, but ultrasound measurements by the 180 day follow up indicate a proximal arterial flow rate of at least 500 mL/min and a vein inner diameter of at least 5.0 mm at 5 - 8 cm from the anastomosis, and did not require any facilitative endovascular or surgical intervention through the 180 day follow up.

  • Freedom from access-related adverse events through 30 daysAssessed through 30 days

    Freedom from access-related adverse events through 30 days