SAVE-FistulaS: the SelfWrap-Assisted ArterioVEnous Fistulas Study

Sponsor

VenoStent (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT06001827

Collaborator

(none)

200

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

This is a prospective, randomized, multi-center clinical trial for chronic kidney disease (CKD) patients referred for creation of a new AVF in order to assess the safety and effectiveness of SelfWrap, a bioabsorbable perivascular wrap.

Condition or Disease	Intervention/Treatment	Phase
Chronic Kidney Diseases End Stage Renal Disease Arteriovenous Fistula Hemodialysis Access Failure ESRD Vascular Access Complication Renal Failure Catheter Complications Catheter Dysfunction Renal Insufficiency	Device: SelfWrap Bioabsorbable Perivascular Wrap Procedure: Untreated AVF Control	N/A

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 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

SAVE-FistulaS: the SelfWrap-Assisted ArterioVEnous Fistulas Study

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2025

Anticipated Study Completion Date :

Dec 1, 2027

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Treatment Arm

Treated with SelfWrap Bioabsorbable Perivascular Wrap during AVF creation surgery

Device: SelfWrap Bioabsorbable Perivascular Wrap

SelfWrap is applied during arteriovenous fistula (AVF) creation surgery. It provides mechanical support to improve maturation and patency of AVFs.

Other Names:

SelfWrap

Sham Comparator: Control Arm

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

Procedure: Untreated AVF Control

AVF creation surgery without any intervention

Other Names:

Standard of Care

Outcome Measures

Primary Outcome Measures

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.
Rate of access-related events through 180 days [Assessed at up to 6 months]
Rate of access-related events through the 180 day follow up

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.