NCT06001827 SAVE-FistulaS: the SelfWrap-Assisted ArterioVEnous Fistulas Study
| NCT ID | NCT06001827 |
| Status | Recruiting |
| Phase | — |
| Sponsor | VenoStent |
| Condition | Chronic Kidney Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 600 participants |
| Start Date | 2024-01-03 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 600 participants in total. It began in 2024-01-03 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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 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.
Contact & Investigator
Timothy Boire, PhD
STUDY DIRECTOR
VenoStent, Inc.
Frequently Asked Questions
Who can join the NCT06001827 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Kidney Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06001827 currently recruiting?
Yes, NCT06001827 is actively recruiting participants. Contact the research team at mark.barakat@venostent.com for enrollment information.
Where is the NCT06001827 trial being conducted?
This trial is being conducted at Bullhead City, United States, Marana, United States, Phoenix, United States, Tucson, United States and 11 additional locations.
Who is sponsoring the NCT06001827 clinical trial?
NCT06001827 is sponsored by VenoStent. The principal investigator is Timothy Boire, PhD at VenoStent, Inc.. The trial plans to enroll 600 participants.
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