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 Marana Surgery Center
Marana, Arizona 85658
Marana, Arizona 85658
Arizona Kidney Disease & Hypertension Centers (AKDHC) Phoenix Surgery Center
Phoenix, Arizona 85012
Phoenix, Arizona 85012
Banner University Medical Center
Tucson, Arizona 85724
Tucson, Arizona 85724
Orange County Vascular Access Center
Garden Grove, California 92840
Garden Grove, California 92840
Tallahassee Research Institute
Tallahassee, Florida 32308
Tallahassee, Florida 32308
Lutheran Medical Group
Fort Wayne, Indiana 46804
Fort Wayne, Indiana 46804
Surgical Associates of Lexington
Lexington, Kentucky 40503
Lexington, Kentucky 40503
Brigham and Women's Hospital
Boston, Massachusetts 02115
Boston, Massachusetts 02115
Mayo Clinic
Rochester, Minnesota 55905
Rochester, Minnesota 55905
University of Missouri
Columbia, Missouri 65212
Columbia, Missouri 65212
Saint Louis University
St Louis, Missouri 63104
St Louis, Missouri 63104
Washington University School of Medicine
St Louis, Missouri 63110
St Louis, Missouri 63110
Surgical Specialists of Charlotte, P.A.
Charlotte, North Carolina 28226
Charlotte, North Carolina 28226
Vascular Care of South Carolina
Columbia, South Carolina 29203
Columbia, South Carolina 29203
Medical University of South Carolina (MUSC) Orangeburg / Dialysis Access Institute
Orangeburg, South Carolina 29118
Orangeburg, South Carolina 29118
Spartanburg Regional Medical Center
Spartanburg, South Carolina 29650
Spartanburg, South Carolina 29650
James Eric Gardner, MD, PC
Memphis, Tennessee 38115
Memphis, Tennessee 38115
Saint David's HealthCare Partnership, L.P., LLP
Austin, Texas 78701
Austin, Texas 78701
A&V Doctors PLLC
El Paso, Texas 79912
El Paso, Texas 79912
Houston Methodist Research Institute
Houston, Texas 77030
Houston, Texas 77030
Upper Valley Dialysis Access Center, LLC
Mission, Texas 78572
Mission, Texas 78572
Houston Methodist Research Institute (Sugar Land)
Sugar Land, Texas 77479
Sugar Land, Texas 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 600 participants from up to 30 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.