SAVE-FistulaS: the SelfWrap-Assisted ArterioVEnous Fistulas Study

Not Applicable

Recruiting

• Conditions: Arteriovenous Fistula; Renal Failure; Catheter Complications; Hemodialysis Access Failure; Catheter Dysfunction; Chronic Kidney Diseases; Vascular Access Complication; End Stage Renal Disease; Renal Insufficiency; ESRD
• Interventions: Device: SelfWrap Bioabsorbable Perivascular Wrap; Procedure: Untreated AVF Control

• Registration Number: NCT06001827
• Lead Sponsor: VenoStent

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.

Detailed Description

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 25 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.

Study Timeline

• Study First Submitted: 2023-08-14
• Study First Submitted QC: 2023-08-14
• Study First Posted: 2023-08-21
• Study Start: 2024-01-03
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-26
• Last Update Posted: 2025-04-01
• Primary Completion: 2026-09
• Study Completion: 2029-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Arm	SelfWrap Bioabsorbable Perivascular Wrap	Treated with SelfWrap Bioabsorbable Perivascular Wrap during AVF creation surgery
Control Arm	Untreated AVF Control	AVF creation surgery without any intervention (untreated AVF control, or standard of care)

Primary Outcome Measures

Name	Time	Method
Freedom from access-related adverse events through 30 days	Assessed through 30 days	Freedom from access-related adverse events through 30 days
Unassisted Maturation by 180 days	Assessed at up to 6 months	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.

Trial Locations

Locations (22)

Surgical Associates of Lexington; 🇺🇸 Lexington, Kentucky, United States

AKDHC Bullhead City; 🇺🇸 Bullhead City, Arizona, United States

Tallahassee Research Institute; 🇺🇸 Tallahassee, Florida, United States

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

Saint Louis University; 🇺🇸 Saint Louis, Missouri, United States

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States

MUSC Charleston; 🇺🇸 Charleston, South Carolina, United States

Northwell Health; 🇺🇸 Lake Success, New York, United States

MUSC Black River; 🇺🇸 Florence, South Carolina, United States

Houston Methodist Research Institute (Sugar Land); 🇺🇸 Sugar Land, Texas, United States

Arizona Kidney Disease & Hypertension Centers (AKDHC) Phoenix Surgery Center; 🇺🇸 Phoenix, Arizona, United States

Surgical Specialists of Charlotte, P.A.; 🇺🇸 Charlotte, North Carolina, United States

Prisma Health; 🇺🇸 Greenville, South Carolina, United States

Spartanburg Regional Medical Center; 🇺🇸 Spartanburg, South Carolina, United States

Saint David's HealthCare Partnership, L.P., LLP; 🇺🇸 Austin, Texas, United States

AKDHC Marana Surgery Center; 🇺🇸 Marana, Arizona, United States

Banner University Medical Center; 🇺🇸 Tucson, Arizona, United States

Lutheran Medical Group; 🇺🇸 Fort Wayne, Indiana, United States

University of Missouri; 🇺🇸 Columbia, Missouri, United States

WakeMed; 🇺🇸 Raleigh, North Carolina, United States

Medical University of South Carolina (MUSC) Orangeburg / Dialysis Access Institute; 🇺🇸 Orangeburg, South Carolina, United States

Houston Methodist Research Institute; 🇺🇸 Houston, Texas, United States