SAVE-FistulaS: the SelfWrap-Assisted ArterioVEnous Fistulas Study

Part of paid clinical trials in Bullhead City, Arizona.

Sponsor
VenoStent
Study ID
NCT06001827
Status
Recruiting
Apply to this trial

Conditions

  • Arteriovenous Fistula
  • Catheter Complications
  • Catheter Dysfunction
  • Chronic Kidney Diseases
  • ESRD
  • End Stage Renal Disease
  • Hemodialysis Access Failure
  • Renal Failure
  • Renal Insufficiency
  • Vascular Access Complication

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SelfWrap Bioabsorbable Perivascular Wrap — DEVICE
    SelfWrap is applied during arteriovenous fistula (AVF) creation surgery. It provides mechanical support to improve maturation and patency of AVFs.
  • Untreated AVF Control — PROCEDURE
    AVF creation surgery without any intervention

Study Details

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.

Key Dates

Start date
Jan 3, 2024
Status verified
Feb 2026
Primary completion
Jun 30, 2027
Completion
Dec 31, 2029

Study Design

Enrollment
600 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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)

Primary Outcome Measure

Unassisted Maturation by 180 days [ Time Frame: Assessed at up to 6 months ]

Central Contacts

Locations (28)

FacilityCityStateZIPSite coordinators
AKDHC Bullhead CityBullhead CityArizona86442
Cynthia Carrizoza
[email protected]
Rick Mishler, MD (PRINCIPAL_INVESTIGATOR)
AKDHC Marana Surgery CenterMaranaArizona85658
Anell S Munoz Gallego
[email protected]
Zhongguang (Ziggy) Yang, MD, PhD (PRINCIPAL_INVESTIGATOR)
Arizona Kidney Disease & Hypertension Centers (AKDHC) Phoenix Surgery CenterPhoenixArizona85012
Cynthia Carrizoza
[email protected]
(602) 200-8288
Shouwen Wang, MD, PhD (PRINCIPAL_INVESTIGATOR)
Banner University Medical CenterTucsonArizona85724
Jennifer Lopez
[email protected]
Wei Zhou, MD (PRINCIPAL_INVESTIGATOR)
Orange County Vascular Access CenterGarden GroveCalifornia92840
Nicole Hilton
[email protected]
803-252-3373
Steven Posner, MD (PRINCIPAL_INVESTIGATOR)
Tallahassee Research InstituteTallahasseeFlorida32308
Brianna Everett
[email protected]
Andres Vargas, MD (PRINCIPAL_INVESTIGATOR)
Lutheran Medical GroupFort WayneIndiana46804
Barbara Anderson
[email protected]
260-458-3555
Sharon Eichman
Vincent Scavo, MD (PRINCIPAL_INVESTIGATOR)
Surgical Associates of LexingtonLexingtonKentucky40503
Amanda Gaddis
[email protected]
Colby Atkins, MD (PRINCIPAL_INVESTIGATOR)
Brigham and Women's HospitalBostonMassachusetts02115
Navya Kotturu
[email protected]
Danielle Montano
[email protected]
Mohamad Hussain, MD, PhD (PRINCIPAL_INVESTIGATOR)
Mayo ClinicRochesterMinnesota55905
Jess Schneider
[email protected]
507-284-2511
Randall DeMartino, MD (PRINCIPAL_INVESTIGATOR)
University of MissouriColumbiaMissouri65212
Brianna Ledbetter
[email protected]
573-882-4387
Jennifer Randolph
[email protected]
573-882-4387
Jonathan Bath, MD (PRINCIPAL_INVESTIGATOR)
Saint Louis UniversitySt LouisMissouri63104
Kathryn Lindsay
[email protected]
Craig Dedert
[email protected]
Matthew Smeds, MD (PRINCIPAL_INVESTIGATOR)
Washington University School of MedicineSt LouisMissouri63110
Ashley Cosentino
[email protected]
Laura McDonald
[email protected]
Mohamed Zayed, MD, PhD (PRINCIPAL_INVESTIGATOR)
Northwell HealthLake SuccessNew York11042
Victoria Wairimu
[email protected]
Yana Etkin, MD (PRINCIPAL_INVESTIGATOR)
Surgical Specialists of Charlotte, P.A.CharlotteNorth Carolina28226
Decca Taylor
[email protected]
(704) 945-3560
Crystal Turner
[email protected]
Jason Burgess, MD (PRINCIPAL_INVESTIGATOR)
WakeMedRaleighNorth Carolina27610
Jenna Cassels
[email protected]
919-350-5252
Rhonda Norton
Kirk Charles, MD (PRINCIPAL_INVESTIGATOR)
MUSC CharlestonCharlestonSouth Carolina29425
Natalie Koren
[email protected]
Adam Tanious, MD (PRINCIPAL_INVESTIGATOR)
Vascular Care of South CarolinaColumbiaSouth Carolina29203
Alicia Phillips-Pough, RN
[email protected]
803-252-3373
Dion Franga, MD (PRINCIPAL_INVESTIGATOR)
MUSC Black RiverFlorenceSouth Carolina29505
Patricia Robinson
[email protected]
Tannesha Clements
[email protected]
Cary Brewton, DO (PRINCIPAL_INVESTIGATOR)
Prisma HealthGreenvilleSouth Carolina29615
Nikita Kasinger
[email protected]
Christopher Carsten, MD (PRINCIPAL_INVESTIGATOR)
Medical University of South Carolina (MUSC) Orangeburg / Dialysis Access InstituteOrangeburgSouth Carolina29118
Virginia Anderson
[email protected]
(803) 395-3878
Amy Lawson
[email protected]
Mark London, MD (PRINCIPAL_INVESTIGATOR)
Spartanburg Regional Medical CenterSpartanburgSouth Carolina29650
Darla Howard
[email protected]
Shannon Stancil
[email protected]
Ari Kramer, MD (PRINCIPAL_INVESTIGATOR)
James Eric Gardner, MD, PCMemphisTennessee38115
Hannah Gardner
[email protected]
901-493-7821
James E Gardner, MD (PRINCIPAL_INVESTIGATOR)
Saint David's HealthCare Partnership, L.P., LLPAustinTexas78701
Shir Yelovitch, PhD
[email protected]
(512) 459-3300
Ryan Turley, MD (PRINCIPAL_INVESTIGATOR)
A&V Doctors PLLCEl PasoTexas79912
Joshua Crawford
[email protected]
915-307-7800
Emmanuel Anekwe, MD (PRINCIPAL_INVESTIGATOR)
Houston Methodist Research InstituteHoustonTexas77030
Caroline Antunes
[email protected]
Eric Peden, MD (PRINCIPAL_INVESTIGATOR)
Upper Valley Dialysis Access Center, LLCMissionTexas78572
Martha Perez
[email protected]
956-600-8899
Chijoke Ogbu, MD (PRINCIPAL_INVESTIGATOR)
Houston Methodist Research Institute (Sugar Land)Sugar LandTexas77479
Sheila Moore
[email protected]
Eric Peden, MD (PRINCIPAL_INVESTIGATOR)

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AKDHC Bullhead City· Bullhead City, AZAKDHC Marana Surgery Center· Marana, AZArizona Kidney Disease & Hypertension Centers (AKDHC) Phoenix Surgery Center· Phoenix, AZBanner University Medical Center· Tucson, AZOrange County Vascular Access Center· Garden Grove, CATallahassee Research Institute· Tallahassee, FL

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