SAVE-FistulaS: the SelfWrap-Assisted ArterioVEnous Fistulas Study
VenoStent · NCT06001827
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18+ · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Not applicable
- Target enrollment
- 600
- US sites recruiting
- 28
- Study start
- January 3, 2024
- Record last updated
- February 17, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: SelfWrap Bioabsorbable Perivascular Wrap; Untreated AVF Control
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 criteria
Copied from the official record. The study team makes the final decision at screening.
Show full 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.
Recruiting US locations
AKDHC Bullhead City
Bullhead City, AZ 86442
Site contact: Cynthia Carrizoza · ccarrizoza@akdhc.com
AKDHC Marana Surgery Center
Marana, AZ 85658
Site contact: Anell S Munoz Gallego · amgallego@akdhc.com
Arizona Kidney Disease & Hypertension Centers (AKDHC) Phoenix Surgery Center
Phoenix, AZ 85012
Site contact: Cynthia Carrizoza · (602) 200-8288 · ccarrizoza@akdhc.com
Banner University Medical Center
Tucson, AZ 85724
Site contact: Jennifer Lopez · jpinedalopez@arizona.edu
Orange County Vascular Access Center
Garden Grove, CA 92840
Site contact: Nicole Hilton · 803-252-3373 · Nicole.Hilton@azuracare.com
Tallahassee Research Institute
Tallahassee, FL 32308
Site contact: Brianna Everett · hopefullybrianna@gmail.com
Lutheran Medical Group
Fort Wayne, IN 46804
Site contact: Barbara Anderson · 260-458-3555 · banderson2@lutheran-hosp.com
Surgical Associates of Lexington
Lexington, KY 40503
Site contact: Amanda Gaddis · gaddisak@yahoo.com
Brigham and Women's Hospital
Boston, MA 02115
Site contact: Navya Kotturu · nkotturu@bwh.harvard.edu
Mayo Clinic
Rochester, MN 55905
Site contact: Jess Schneider · 507-284-2511 · schneider.jessica1@mayo.edu
University of Missouri
Columbia, MO 65212
Site contact: Brianna Ledbetter · 573-882-4387 · balg34@health.missouri.edu
Saint Louis University
St Louis, MO 63104
Site contact: Kathryn Lindsay · kathryn.lindsay@health.slu.edu
Washington University School of Medicine
St Louis, MO 63110
Site contact: Ashley Cosentino · ashley.cosentino@wustl.edu
Northwell Health
Lake Success, NY 11042
Site contact: Victoria Wairimu · mwairimu@northwell.edu
Surgical Specialists of Charlotte, P.A.
Charlotte, NC 28226
Site contact: Decca Taylor · (704) 945-3560 · dtaylor@ssclt.com
WakeMed
Raleigh, NC 27610
Site contact: Jenna Cassels · 919-350-5252 · jcassels@wakemed.org
MUSC Charleston
Charleston, SC 29425
Site contact: Natalie Koren · korenn@musc.edu
Vascular Care of South Carolina
Columbia, SC 29203
Site contact: Alicia Phillips-Pough, RN · 803-252-3373 · alicia.phillips-pough@azuracare.com
MUSC Black River
Florence, SC 29505
Site contact: Patricia Robinson · robinpat@musc.edu
Prisma Health
Greenville, SC 29615
Site contact: Kya Spann · Kya.Spann@prismahealth.org
Medical University of South Carolina (MUSC) Orangeburg / Dialysis Access Institute
Orangeburg, SC 29118
Site contact: Virginia Anderson · (803) 395-3878 · andersvi@musc.edu
Spartanburg Regional Medical Center
Spartanburg, SC 29650
Site contact: Darla Howard · DHoward@srhs.com
James Eric Gardner, MD, PC
Memphis, TN 38115
Site contact: Hannah Gardner · 901-493-7821 · hannahgardner3@gmail.com
Saint David's HealthCare Partnership, L.P., LLP
Austin, TX 78701
Site contact: Shir Yelovitch, PhD · (512) 459-3300 · SYelovitch@ctvstexas.com
A&V Doctors PLLC
El Paso, TX 79912
Site contact: Joshua Crawford · 915-307-7800 · jcrawford@arteriesveins.com
Houston Methodist Research Institute
Houston, TX 77030
Site contact: Caroline Antunes · cantunes@houstonmethodist.org
Upper Valley Dialysis Access Center, LLC
Mission, TX 78572
Site contact: Martha Perez · 956-600-8899 · martha.perez@uvdac.com
Houston Methodist Research Institute (Sugar Land)
Sugar Land, TX 77479
Site contact: Sheila Moore · srmoore@houstonmethodist.org
Study contacts (from the official record)
- Mark Barakat, MD · (832) 429-5362 · mark.barakat@venostent.com