Recruiting

SelfWrapSAVE-FistulaS: the SelfWrap-Assisted ArterioVEnous Fistulas Study

Sponsor:

VenoStent

Code:

NCT06001827

Conditions

Chronic Kidney Diseases

End Stage Renal Disease

Arteriovenous Fistula

Hemodialysis Access Failure

ESRD

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

SelfWrap Bioabsorbable Perivascular Wrap

Untreated AVF Control

Study Details

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.

Conditions

Chronic Kidney Diseases

End Stage Renal Disease

Arteriovenous Fistula

Hemodialysis Access Failure

ESRD

Study ID

NCT06001827

Start date

Jan 3, 2024

Status verified date

Feb, 2026

Completion date

Dec, 2029

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

600 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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)

Interventions

SelfWrap Bioabsorbable Perivascular Wrap

SelfWrap is applied during arteriovenous fistula (AVF) creation surgery. It provides mechanical support to improve maturation and patency of AVFs.

Untreated AVF Control

AVF creation surgery without any intervention

Primary outcome measure

Unassisted Maturation by 180 days [ Time Frame: Assessed at up to 6 months ]
Freedom from access-related adverse events through 30 days [ Time Frame: Assessed through 30 days ]

Central Contacts and Locations

Central contacts

Mark Barakat, MD

(832) 429-5362 mark.barakat@venostent.com

Locations

AKDHC Bullhead City

Recruiting

Bullhead City, Arizona, United States, 86442

Contacts

Cynthia Carrizoza

ccarrizoza@akdhc.com

Principal Investigator:

Rick Mishler, MD

AKDHC Marana Surgery Center

Recruiting

Marana, Arizona, United States, 85658

Contacts

Anell S Munoz Gallego

amgallego@akdhc.com

Principal Investigator:

Zhongguang (Ziggy) Yang, MD, PhD

Arizona Kidney Disease & Hypertension Centers (AKDHC) Phoenix Surgery Center

Recruiting

Phoenix, Arizona, United States, 85012

Contacts

Cynthia Carrizoza

(602) 200-8288 ccarrizoza@akdhc.com

Principal Investigator:

Shouwen Wang, MD, PhD

Banner University Medical Center

Recruiting

Tucson, Arizona, United States, 85724

Contacts

Jennifer Lopez

jpinedalopez@arizona.edu

Principal Investigator:

Wei Zhou, MD

Orange County Vascular Access Center

Recruiting

Garden Grove, California, United States, 92840

Contacts

Nicole Hilton

803-252-3373 Nicole.Hilton@azuracare.com

Principal Investigator:

Steven Posner, MD

Tallahassee Research Institute

Recruiting

Tallahassee, Florida, United States, 32308

Contacts

Brianna Everett

hopefullybrianna@gmail.com

Principal Investigator:

Andres Vargas, MD

Lutheran Medical Group

Recruiting

Fort Wayne, Indiana, United States, 46804

Contacts

Barbara Anderson

260-458-3555 banderson2@lutheran-hosp.com

Principal Investigator:

Vincent Scavo, MD

Surgical Associates of Lexington

Recruiting

Lexington, Kentucky, United States, 40503

Contacts

Amanda Gaddis

gaddisak@yahoo.com

Principal Investigator:

Colby Atkins, MD

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Navya Kotturu

nkotturu@bwh.harvard.edu

Danielle Montano

dmontano2@bwh.harvard.edu

Principal Investigator:

Mohamad Hussain, MD, PhD

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Jess Schneider

507-284-2511 schneider.jessica1@mayo.edu

Principal Investigator:

Randall DeMartino, MD

University of Missouri

Recruiting

Columbia, Missouri, United States, 65212

Contacts

Brianna Ledbetter

573-882-4387 balg34@health.missouri.edu

Jennifer Randolph

573-882-4387 randolphjl@health.missouri.edu

Principal Investigator:

Jonathan Bath, MD

Saint Louis University

Recruiting

St Louis, Missouri, United States, 63104

Contacts

Kathryn Lindsay

kathryn.lindsay@health.slu.edu

Craig Dedert

craig.dedert@health.slu.edu

Principal Investigator:

Matthew Smeds, MD

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Ashley Cosentino

ashley.cosentino@wustl.edu

Laura McDonald

m.laura@wustl.edu

Principal Investigator:

Mohamed Zayed, MD, PhD

Northwell Health

Recruiting

Lake Success, New York, United States, 11042

Contacts

Victoria Wairimu

mwairimu@northwell.edu

Principal Investigator:

Yana Etkin, MD

Surgical Specialists of Charlotte, P.A.

Recruiting

Charlotte, North Carolina, United States, 28226

Contacts

Decca Taylor

(704) 945-3560 dtaylor@ssclt.com

Crystal Turner

cturner@ssclt.com

Principal Investigator:

Jason Burgess, MD

WakeMed

Recruiting

Raleigh, North Carolina, United States, 27610

Contacts

Jenna Cassels

919-350-5252 jcassels@wakemed.org

Principal Investigator:

Kirk Charles, MD

MUSC Charleston

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Natalie Koren

korenn@musc.edu

Principal Investigator:

Adam Tanious, MD

Vascular Care of South Carolina

Recruiting

Columbia, South Carolina, United States, 29203

Contacts

Alicia Phillips-Pough, RN

803-252-3373 alicia.phillips-pough@azuracare.com

Principal Investigator:

Dion Franga, MD

MUSC Black River

Recruiting

Florence, South Carolina, United States, 29505

Contacts

Patricia Robinson

robinpat@musc.edu

Tannesha Clements

clemtann@musc.edu

Principal Investigator:

Cary Brewton, DO

Prisma Health

Recruiting

Greenville, South Carolina, United States, 29615

Contacts

Kya Spann

Kya.Spann@prismahealth.org

Nikita Kasinger

Nikita.Kasinger@PrismaHealth.org

Principal Investigator:

Christopher Carsten, MD

Medical University of South Carolina (MUSC) Orangeburg / Dialysis Access Institute

Recruiting

Orangeburg, South Carolina, United States, 29118

Contacts

Virginia Anderson

(803) 395-3878 andersvi@musc.edu

Amy Lawson

lawsoamy@musc.edu

Principal Investigator:

Mark London, MD

Spartanburg Regional Medical Center

Recruiting

Spartanburg, South Carolina, United States, 29650

Contacts

Darla Howard

DHoward@srhs.com

Shannon Stancil

SStancil@srhs.com

Principal Investigator:

Ari Kramer, MD

James Eric Gardner, MD, PC

Recruiting

Memphis, Tennessee, United States, 38115

Contacts

Hannah Gardner

901-493-7821 hannahgardner3@gmail.com

Principal Investigator:

James E Gardner, MD

Saint David's HealthCare Partnership, L.P., LLP

Recruiting

Austin, Texas, United States, 78701

Contacts

Shir Yelovitch, PhD

(512) 459-3300 SYelovitch@ctvstexas.com

Principal Investigator:

Ryan Turley, MD

A&V Doctors PLLC

Recruiting

El Paso, Texas, United States, 79912

Contacts

Joshua Crawford

915-307-7800 jcrawford@arteriesveins.com

Principal Investigator:

Emmanuel Anekwe, MD

Houston Methodist Research Institute

Recruiting

Houston, Texas, United States, 77030

Contacts

Caroline Antunes

cantunes@houstonmethodist.org

Principal Investigator:

Eric Peden, MD

Upper Valley Dialysis Access Center, LLC

Recruiting

Mission, Texas, United States, 78572

Contacts

Martha Perez

956-600-8899 martha.perez@uvdac.com

Principal Investigator:

Chijoke Ogbu, MD

Houston Methodist Research Institute (Sugar Land)

Recruiting

Sugar Land, Texas, United States, 77479

Contacts

Sheila Moore

srmoore@houstonmethodist.org

Principal Investigator:

Eric Peden, MD

More Information

Sponsor

VenoStent

Last update posted

Feb 17, 2026

Last verified

Feb, 2026

Keywords

Vascular Surgery
Vascular Access
Nephrology
Bioabsorbable
Perivascular Wrap
External Support
Hemodialysis
Dialysis
Chronic Kidney Disease
End Stage Renal Disease
Arteriovenous Fistula
AVF

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-22. This information was provided to ClinicalTrials.gov by VenoStent on 2026-02-17.