SAVE-FistulaS: the SelfWrap-Assisted ArterioVEnous Fistulas Study

VenoStent

Status: Enrolling

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

Treatments: Device: SelfWrap Bioabsorbable Perivascular Wrap; Procedure: Untreated AVF Control

Study type: Interventional

Funder types: Industry

Identifiers

NCT06001827

VENO-CIP002

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 2 patient groups

Treatment Arm

Experimental group

Description:

Treated with SelfWrap Bioabsorbable Perivascular Wrap during AVF creation surgery

Treatment:

Device: SelfWrap Bioabsorbable Perivascular Wrap

Control Arm

Sham Comparator group

Description:

AVF creation surgery without any intervention (untreated AVF control, or standard of care)

Treatment:

Procedure: Untreated AVF Control