What is SelfWrap studying for chronic kidney disease?

SelfWrap is being studied to see if it can improve the safety and effectiveness of arteriovenous fistulas created for patients with chronic kidney disease. Researchers want to find out if using SelfWrap during surgery helps the fistula mature better and lasts longer. The study is sponsored by VenoStent and involves multiple centers.

Who may be eligible for this chronic kidney disease clinical trial?

Adults aged 18 years and older who are referred for creation of a new arteriovenous fistula can be eligible. Both males and females may participate, but females of childbearing potential must have a current negative pregnancy test. Key exclusions include certain blood vessel sizes, existing fistula repairs, infections, coagulation disorders, and recent participation in other studies. Please review eligibility criteria for more details.

Is there any cost to participate in this chronic kidney disease clinical trial?

Study-related care, including the study device and all trial visits, is provided at no cost. However, personal travel expenses to attend visits may vary and are not guaranteed to be reimbursed. Participants should plan accordingly for any travel costs.

Actively Recruiting

Phase Not Applicable

Age: 18Years +

All Genders

ID06001827

SAVE-FistulaS Study Evaluating the Safety and Effectiveness of SelfWrap Device in Creating New Arteriovenous Fistulas for Chronic Kidney Disease Patients

Led by VenoStent · Updated on 2026-02-17

600

Participants Needed

Research Sites

130 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and effectiveness of SelfWrap, a bioabsorbable perivascular wrap, in patients with chronic kidney disease CKD who are referred for creation of a new arteriovenous fistula AVF. This multi-center, prospective, randomized, double-arm, single-blind clinical trial involves about 600 participants across up to 30 sites. The purpose is to compare SelfWrap-assisted AVF creation with the standard surgical procedure without any additional intervention over a 36-month follow-up period. Participants are randomly assigned to one of two groups one receiving the SelfWrap device during AVF creation surgery, and the other undergoing the usual AVF surgery without intervention as a control group. The SelfWrap device offers mechanical support intended to improve the maturation and patency of the fistula. The trial follows participants for 36 months after surgery to monitor outcomes. During the study, participants will undergo assessments to measure unassisted maturation of the AVF at up to 6 months and monitor freedom from access-related adverse events through 30 days. Researchers will evaluate safety and effectiveness through these primary outcome measures. Participants are expected to comply with study requirements and attend follow-up visits throughout the 36-month period to allow comprehensive evaluation of the devices impact and any complications.

CONDITIONS

Brief Title

SAVE-FistulaS: the SelfWrap-Assisted ArterioVEnous Fistulas Study

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Age of at least 18 years
Referred for creation of a new arteriovenous fistula (AVF)
Willing and able to comply with study requirements, communicate with the study team, and attend follow-up visits over 36 months

You will not qualify if you...

Planned procedure to revise or repair an existing fistula
Target artery inner diameter less than 2.0 mm measured by ultrasound
Target vein inner diameter less than 2.0 mm measured by ultrasound
Significant stenosis (at least 50%) at the target vein on the surgery side
Known central venous stenosis of at least 50% on the surgery side
Presence of a stent or stent graft within the access circuit
Known or suspected coagulation disorder posing high risk for AVF creation
Known or suspected active infection at time of surgery
Congestive heart failure NYHA class 4
Prior steal syndrome on the surgery side
Currently enrolled or previously enrolled in another investigational drug, device, or biological study
Life expectancy less than 12 months
Expected kidney transplant within 6 months of enrollment
Expected to undergo home hemodialysis
Females of childbearing potential without a documented current negative pregnancy test
Comorbid condition that may confound safety and efficacy data
Unwillingness or inability to give consent or comply with follow-up
Any health condition interfering with safety or compliance as judged by investigator

Research Team

Mark Barakat, MD

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SAVE-FistulaS Study Evaluating the Safety and Effectiveness of SelfWrap Device in Creating New Arteriovenous Fistulas for Chronic Kidney Disease Patients

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria