SelfWrap-Assisted Arteriovenous Fistulas

Study Overview
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Brief Summary
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This is a single-center, prospective, single-arm clinical study to evaluate the feasibility, safety, and performance of VenoStent's SelfWrap® Bioabsorbable Perivascular Wrap on arteriovenous fistulas (AVFs). All participants are chronic kidney disease (CKD) patients already receiving hemodialysis treatments that are referred for creation of a new arteriovenous fistula (AVF).

Official Title
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Initial Feasibility Study of SelfWrap-Assisted Arteriovenous Fistulas (SW-AVF)

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

Intervention / Treatment
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* Device: SelfWrap Bioabsorbable Perivascular Wrap


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years, male or female; Subjects already receiving hemodialysis treatments that are ultimately referred for a new AVF, per current US KDOQI Clinical Practice Guidelines for Vascular Access updated in 2019 which recommend an AVF or arteriovenous graft (AVG) consistent with patient life-plan, overall goals of care, and anticipated duration of hemodialysis; if life expectancy > 1 year, recommend forearm AVF, forearm AVG, or upper arm AVF; if < 1 year, recommend forearm AVG/upper arm AVG; if urgent start, early cannulation AVG or central venous catheter (CVC); Target cephalic vein inner diameter ≥ 2.5 mm and target artery ≥ 2.0 mm as measured via duplex ultrasound with a tourniquet applied; For radial AVFs, a nonpathological modified Allen test; Triphasic arterial flow and intact venous outflow; A vascular access site being used for hemodialysis that is either positioned contralateral to the planned AVF creation surgery or located in the groin. If the catheter is positioned on the same side as the planned AVF, the catheter will be moved to the other arm prior to the AVF created surgery. Participant is willing and able to comply with study requirements and sign an informed consent. Exclusion Criteria: Planned index procedure to revise or repair an existing fistula; Twelve months or longer with a catheter, on the planned side of AVF creation; or if there has been any previously failed AVF and AVG on the planned side of AVF creation. Significant (> 50%) stenosis at the target vein on the side of surgery, as diagnosed by preoperative ultrasound; Known central venous stenosis > 50%; Amputated limb; Use of a peripherally-inserted central catheter (PICC) line; Abnormal cardiac rhythm; Known coagulation disorder; 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 and has not completed the primary endpoint(s), or was previously enrolled in this study; Life expectancy less than 12 months; Patient expecting to undergo kidney transplant surgery within 12 months of enrollment; Patient has a comorbid condition that, in the judgment of the Investigator, may cause him/her to be non-compliant with the protocol or confound data interpretation. Unwillingness or inability to give consent and/or comply with the study follow up schedule.

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SelfWrap-treated<br>Treated with SelfWrap Bioabsorbable Perivascular Wrap during AVF creation surgery | Device: SelfWrap Bioabsorbable Perivascular Wrap<br>* SelfWrap is applied during the normal arteriovenous fistula (AVF) creation procedure. It provides mechanical support to the vein and induces outward remodeling to improve maturation and patency of AVFs.<br>* Other names: SelfWrap;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Patency | Proportion of participants with a created AVF that is not abandoned nor occluded and is free from access thrombosis as well as any intervention required to facilitate, maintain, or reestablish patency (e.g. angioplasty), through 6 months | Through 6 months post-AVF creation | 
| Cumulative Patency | Proportion of participants with a created AVF that is not abandoned or occluded, through 6 months | Through 6 months post-AVF creation | 
| Freedom from Device-Related Safety Events | Proportion of participants with freedom from device-related infection, thrombosis, aneurysm, pseudoaneurysm, major bleeding, and rehospitalizations | Through 6 months post-AVF creation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Patency | Proportion of participants with a created AVF that is not abandoned nor occluded and is free from access thrombosis as well as any intervention required to facilitate, maintain, or reestablish patency (e.g. angioplasty), through 1, 2, 3, and 12 months | Through 1, 2, 3, 12, 18, and 24 months post-AVF creation | 
| Cumulative Patency | Proportion of participants with a created AVF that is not abandoned or occluded, through 1, 2, 3, and 12 months | Through 1, 2, 3, 12, 18, and 24 months post-AVF creation | 
| Number of Interventions |  | Through 1, 2, 3, 6, 12, 18, and 24 months post-AVF creation | 
| Unassisted Physiological Maturation | A created AVF with a proximal arterial flow rate ≥ 500 mL/min and a vein inner diameter ≥ 4.0 mm near the cannulation site, in absence of intervention(s) to initially establish this flow rate and vein size | 1, 2, 3, and 6 months post-AVF creation | 
| Freedom from Device-Related Safety Events | Proportion of participants with freedom from device-related infection, thrombosis, aneurysm, pseudoaneurysm, major bleeding, and rehospitalizations | Through 1, 2, 3, 12, 18, and 24 months post-AVF creation | 

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