SAVE-FistulaS: the SelfWrap-Assisted ArterioVEnous Fistulas Study

NARecruitingINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

January 3, 2024

Primary Completion Date

September 30, 2026

Study Completion Date

March 31, 2029

Conditions
Chronic Kidney DiseasesEnd Stage Renal DiseaseArteriovenous FistulaHemodialysis Access FailureESRDVascular Access ComplicationRenal FailureCatheter ComplicationsCatheter DysfunctionRenal Insufficiency
Interventions
DEVICE

SelfWrap Bioabsorbable Perivascular Wrap

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

PROCEDURE

Untreated AVF Control

AVF creation surgery without any intervention

Trial Locations (22)

11042

RECRUITING

Northwell Health, Lake Success

27610

RECRUITING

WakeMed, Raleigh

28226

RECRUITING

Surgical Specialists of Charlotte, P.A., Charlotte

29118

RECRUITING

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

29425

RECRUITING

MUSC Charleston, Charleston

29505

RECRUITING

MUSC Black River, Florence

29615

RECRUITING

Prisma Health, Greenville

29650

RECRUITING

Spartanburg Regional Medical Center, Spartanburg

32308

RECRUITING

Tallahassee Research Institute, Tallahassee

40503

RECRUITING

Surgical Associates of Lexington, Lexington

46804

RECRUITING

Lutheran Medical Group, Fort Wayne

63104

RECRUITING

Saint Louis University, St Louis

63110

RECRUITING

Washington University School of Medicine, St Louis

65212

RECRUITING

University of Missouri, Columbia

77030

RECRUITING

Houston Methodist Research Institute, Houston

77479

RECRUITING

Houston Methodist Research Institute (Sugar Land), Sugar Land

78701

RECRUITING

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

85012

RECRUITING

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

85658

RECRUITING

AKDHC Marana Surgery Center, Marana

85724

RECRUITING

Banner University Medical Center, Tucson

86442

RECRUITING

AKDHC Bullhead City, Bullhead City

02115

RECRUITING

Brigham and Women's Hospital, Boston

Sponsors

Lead Sponsor

All Listed Sponsors
lead

VenoStent

INDUSTRY

NCT06001827 - SAVE-FistulaS: the SelfWrap-Assisted ArterioVEnous Fistulas Study | Biotech Hunter | Biotech Hunter