NCT06001827 · VenoStent
SAVE-FistulaS: the SelfWrap-Assisted ArterioVEnous Fistulas Study
(SAVE-FistulaS)
What this study is about
This is a forward-looking, randomly assigned, 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Bullhead City, Arizona
- Marana, Arizona
- Phoenix, Arizona
- Tucson, Arizona
- Garden Grove, California
- Tallahassee, Florida
- Fort Wayne, Indiana
- Lexington, Kentucky
- Boston, Massachusetts
- Rochester, Minnesota
- Columbia, Missouri
- St Louis, Missouri
And 15 more locations — see the full list below.
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 17, 2026 · Source of record for eligibility and locations