SAVE-FistulaS: the SelfWrap-Assisted ArterioVEnous Fistulas Study

Chronic Kidney Diseases Clinical Trial

— SAVE-FistulaS  

Official title:

SAVE-FistulaS: the SelfWrap-Assisted ArterioVEnous Fistulas Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06001827
• Other study ID #: VENO-CIP002
• Status: Recruiting
• Phase: N/A
• Start date: November 20, 2023
• Est. completion date: December 2027

Study information

• Verified date: March 2024
• Source: VenoStent
• Contact: Mark Barakat, MD
• Phone: (832) 429-5362
• Email: mark.barakat[@]venostent.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2027
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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.

Procedure:
• Untreated AVF Control
AVF creation surgery without any intervention

Locations

Country	Name	City	State
United States	Cardiothoracic and Vascular Surgeons	Austin	Texas
United States	Surgical Specialists of Charlotte, PA	Charlotte	North Carolina
United States	Lutheran Medical Group	Fort Wayne	Indiana
United States	AKDHC Marana Surgery Center	Marana	Arizona
United States	Medical University of South Carolina (MUSC) Orangeburg / Dialysis Access Institute	Orangeburg	South Carolina
United States	Arizona Kidney Disease & Hypertension Centers (AKDHC) Phoenix Surgery Center	Phoenix	Arizona
United States	WakeMed	Raleigh	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
VenoStent

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Freedom from access-related adverse events through 30 days	Freedom from access-related adverse events through 30 days	Assessed through 30 days

External Links

•   VenoStent website