SAVE-FistulaS: the SelfWrap-Assisted ArterioVEnous Fistulas Study
Purpose
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.
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
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Treatment Arm |
Treated with SelfWrap Bioabsorbable Perivascular Wrap during AVF creation surgery |
|
|
Sham Comparator Control Arm |
AVF creation surgery without any intervention (untreated AVF control, or standard of care) |
|
Recruiting Locations
AKDHC Bullhead City
Bullhead City 5287565, Arizona 5551752 86442
Bullhead City 5287565, Arizona 5551752 86442
AKDHC Marana Surgery Center
Marana 5303705, Arizona 5551752 85658
Marana 5303705, Arizona 5551752 85658
Arizona Kidney Disease & Hypertension Centers (AKDHC) Phoenix Surgery Center
Phoenix 5308655, Arizona 5551752 85012
Phoenix 5308655, Arizona 5551752 85012
Banner University Medical Center
Tucson 5318313, Arizona 5551752 85724
Tucson 5318313, Arizona 5551752 85724
Tallahassee Research Institute
Tallahassee 4174715, Florida 4155751 32308
Tallahassee 4174715, Florida 4155751 32308
Lutheran Medical Group
Fort Wayne 4920423, Indiana 4921868 46804
Fort Wayne 4920423, Indiana 4921868 46804
Surgical Associates of Lexington
Lexington 4297983, Kentucky 6254925 40503
Lexington 4297983, Kentucky 6254925 40503
Brigham and Women's Hospital
Boston 4930956, Massachusetts 6254926 02115
Boston 4930956, Massachusetts 6254926 02115
University of Missouri
Columbia 4381982, Missouri 4398678 65212
Columbia 4381982, Missouri 4398678 65212
Saint Louis University
St Louis 4407066, Missouri 4398678 63104
St Louis 4407066, Missouri 4398678 63104
Washington University School of Medicine
St Louis 4407066, Missouri 4398678 63110
St Louis 4407066, Missouri 4398678 63110
Northwell Health
Lake Success 5123853, New York 5128638 11042
Lake Success 5123853, New York 5128638 11042
Surgical Specialists of Charlotte, P.A.
Charlotte 4460243, North Carolina 4482348 28226
Charlotte 4460243, North Carolina 4482348 28226
WakeMed
Raleigh 4487042, North Carolina 4482348 27610
Raleigh 4487042, North Carolina 4482348 27610
MUSC Charleston
Charleston 4574324, South Carolina 4597040 29425
Charleston 4574324, South Carolina 4597040 29425
MUSC Black River
Florence 4578737, South Carolina 4597040 29505
Florence 4578737, South Carolina 4597040 29505
Prisma Health
Greenville 4580543, South Carolina 4597040 29615
Greenville 4580543, South Carolina 4597040 29615
Medical University of South Carolina (MUSC) Orangeburg / Dialysis Access Institute
Orangeburg 4590184, South Carolina 4597040 29118
Orangeburg 4590184, South Carolina 4597040 29118
Spartanburg Regional Medical Center
Spartanburg 4597200, South Carolina 4597040 29650
Spartanburg 4597200, South Carolina 4597040 29650
Saint David's HealthCare Partnership, L.P., LLP
Austin 4671654, Texas 4736286 78701
Austin 4671654, Texas 4736286 78701
Houston Methodist Research Institute
Houston 4699066, Texas 4736286 77030
Houston 4699066, Texas 4736286 77030
Houston Methodist Research Institute (Sugar Land)
Sugar Land 4734825, Texas 4736286 77479
Sugar Land 4734825, Texas 4736286 77479
More Details
- NCT ID
- NCT06001827
- Status
- Recruiting
- Sponsor
- VenoStent
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.