SAVE-FistulaS: the SelfWrap-Assisted ArterioVEnous Fistulas Study

Study Overview
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Brief Summary
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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.

Detailed Description
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This is a multi-center, prospective, randomized, double-arm, single-blind, evaluator-blinded clinical trial for CKD patients referred for creation of a new arteriovenous fistula (AVF). This study will involve approximately 200 participants from up to 20 investigational sites, randomized 1:1 to treatment with the SelfWrap or the untreated AVF control (i.e. standard of care, SOC). Participants will be followed for a duration of 36 months.

Official Title
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SAVE-FistulaS: the SelfWrap-Assisted ArterioVEnous Fistulas Study

Conditions
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Renal Failure, Chronic Kidney Diseases, End Stage Renal Disease, Arteriovenous Fistula, Hemodialysis Access Failure, ESRD, Vascular Access Complication, Catheter Complications, Catheter Dysfunction, Renal Insufficiency

Intervention / Treatment
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* Device: SelfWrap Bioabsorbable Perivascular Wrap
* Procedure: Untreated AVF Control


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Arm<br>Treated with SelfWrap Bioabsorbable Perivascular Wrap during AVF creation surgery | Device: SelfWrap Bioabsorbable Perivascular Wrap<br>* SelfWrap is applied during arteriovenous fistula (AVF) creation surgery. It provides mechanical support to improve maturation and patency of AVFs.<br>* Other names: SelfWrap;|
| Sham Comparator: Control Arm<br>AVF creation surgery without any intervention (untreated AVF control, or standard of care) | Procedure: Untreated AVF Control<br>* AVF creation surgery without any intervention<br>* Other names: Standard of Care;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Unassisted Maturation by 180 days | A participant who is either 1) on hemodialysis on or before day 150 and the AVF has been cannulated with two needles for at least 75% of dialysis sessions within any 4 consecutive week period to achieve the prescribed dialysis by the 180 day follow up, and did not require any facilitative endovascular or surgical intervention to achieve this, or 2) is not on hemodialysis on or before day 150, but ultrasound measurements by the 180 day follow up indicate a proximal arterial flow rate of at least 500 mL/min and a vein inner diameter of at least 5.0 mm at 5 - 8 cm from the anastomosis, and did not require any facilitative endovascular or surgical intervention through the 180 day follow up. | Assessed at up to 6 months | 
| Freedom from access-related adverse events through 30 days | Freedom from access-related adverse events through 30 days | Assessed through 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AVF, Vascular Surgery, Vascular Access, Nephrology, Bioabsorbable, Perivascular Wrap, External Support, Hemodialysis, Dialysis, Chronic Kidney Disease, End Stage Renal Disease, Arteriovenous Fistula