RecruitingNot ApplicableNCT06001827
SAVE-FistulaS: the SelfWrap-Assisted ArterioVEnous Fistulas Study
Sponsor
VenoStent
Enrollment
600 participants
Start Date
Jan 3, 2024
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 Years
Inclusion Criteria3
- 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 Criteria18
- 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.
Interventions
DEVICESelfWrap Bioabsorbable Perivascular Wrap
SelfWrap is applied during arteriovenous fistula (AVF) creation surgery. It provides mechanical support to improve maturation and patency of AVFs.
PROCEDUREUntreated AVF Control
AVF creation surgery without any intervention
Locations(28)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06001827
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