SAVE-FistulaS: the SelfWrap-Assisted ArterioVEnous Fistulas Study

Launched by VENOSTENT · Aug 14, 2023

Keywords

ClinConnect Summary

The SAVE-FistulaS trial is studying a new way to create a fistula, which is an important access point for patients with chronic kidney disease who need hemodialysis. This trial will evaluate the safety and effectiveness of a special wrap called SelfWrap, designed to help the fistula heal better and work more effectively. The trial is looking for participants who are at least 18 years old and have been referred to have a new arteriovenous fistula created. Participants will need to commit to follow-up visits over three years to help us understand how well this treatment works.

To be eligible for this study, potential participants should not have certain health issues that could complicate the procedure, such as existing problems with veins or arteries in the arm where the fistula will be created. They should also be able to communicate with the study team and attend all necessary appointments. If you or someone you know is interested in learning more about this study, it could be a valuable opportunity to contribute to research that may improve treatment options for kidney disease patients.

Gender

ALL

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.