Clinical trial NCT06001827: SAVE-FistulaS: the SelfWrap-Assisted ArterioVEnous Fistulas Study
Official title: SAVE-FistulaS: the SelfWrap-Assisted ArterioVEnous Fistulas Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Kidney Diseases
End Stage Renal Disease
Arteriovenous Fistula
Hemodialysis Access Failure
ESRD
Vascular Access Complication
Renal Failure
Catheter Complications
Catheter Dysfunction
Renal Insufficiency
Keywords: Vascular Surgery
Vascular Access
Nephrology
Bioabsorbable
Perivascular Wrap
External Support
Hemodialysis
Dialysis
Chronic Kidney Disease
End Stage Renal Disease
Arteriovenous Fistula
AVF
Lead sponsor: VenoStent
Sponsor class: INDUSTRY
First posted: 2023-08-21
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Unassisted Maturation by 180 days
timeFrame: Assessed at up to 6 months
measure: Freedom from access-related adverse events through 30 days
timeFrame: Assessed through 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Bullhead City
country: United States
facility: AKDHC Bullhead City
state: Arizona
city: Marana
country: United States
facility: AKDHC Marana Surgery Center
state: Arizona
city: Phoenix
country: United States
facility: Arizona Kidney Disease & Hypertension Centers (AKDHC) Phoenix Surgery Center
state: Arizona
city: Tucson
country: United States
facility: Banner University Medical Center
state: Arizona
city: Tallahassee
country: United States
facility: Tallahassee Research Institute
state: Florida
city: Fort Wayne
country: United States
facility: Lutheran Medical Group
state: Indiana
city: Lexington
country: United States
facility: Surgical Associates of Lexington
state: Kentucky
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Columbia
country: United States
facility: University of Missouri
state: Missouri
city: Saint Louis
country: United States
facility: Saint Louis University
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Lake Success
country: United States
facility: Northwell Health
state: New York
city: Charlotte
country: United States
facility: Surgical Specialists of Charlotte, P.A.
state: North Carolina
city: Raleigh
country: United States
facility: WakeMed
state: North Carolina
city: Charleston
country: United States
facility: MUSC Charleston
state: South Carolina
city: Florence
country: United States
facility: MUSC Black River
state: South Carolina
city: Greenville
country: United States
facility: Prisma Health
state: South Carolina
city: Orangeburg
country: United States
facility: Medical University of South Carolina (MUSC) Orangeburg / Dialysis Access Institute
state: South Carolina
city: Spartanburg
country: United States
facility: Spartanburg Regional Medical Center
state: South Carolina
city: Austin
country: United States
facility: Saint David's HealthCare Partnership, L.P., LLP
state: Texas
city: Houston
country: United States
facility: Houston Methodist Research Institute
state: Texas
city: Sugar Land
country: United States
facility: Houston Methodist Research Institute (Sugar Land)
state: Texas
Study officials:
affiliation: VenoStent, Inc.
name: Timothy Boire, PhD
role: STUDY_DIRECTOR
References: