A Study Testing the Use of a Perivascular Sirolimus Formulation (Sirogen) in ESRD Patients Undergoing AV Fistula Surgery

PHASE3CompletedINTERVENTIONAL
Enrollment

136

Participants

Timeline

Start Date

August 26, 2022

Primary Completion Date

March 18, 2025

Study Completion Date

August 29, 2025

Conditions
Complication of Renal DialysisEnd Stage Renal DiseaseEnd Stage Kidney DiseaseESRDChronic Kidney FailureComplication of HemodialysisVascular Access ComplicationArteriovenous Fistula
Interventions
DRUG

Sirolimus

SeCI placed at and around the site of the anastomosis of an AV fistula, immediately following completion of a successful AV fistula surgery.

Trial Locations (22)

10029

Mount Sinai Hospital, New York

20010

MedStar Cardiovascular Research Network at MedStar Washington Hospital Center, Washington D.C.

23507

Sentara Norfolk General Hospital/Sentara Health Research Center, Norfolk

28204

Atrium Health, Charlotte

28207

Surgical Specialists of Charlotte, Charlotte

29118

The Regional Medical Center/Dialysis Access Institute, Orangeburg

30308

Emory University Hospital Midtown, Atlanta

30912

Augusta University, Augusta

33156

American Access Care of Miami, Miami

38115

James Eric Gardner, MD PC, Memphis

40202

University of Louisville, Louisville

77030

Houston Methodist, Houston

77479

Houston Methodist, Sugar Land

79912

Arteries & Veins, El Paso

90502

Lundquist Institute for Biomedical Innovation, Torrance

92161

Veterans Affairs San Diego Health Center, San Diego

02115

The Brigham and Women's Hospital, Boston

Unknown

University Hospitals Birmingham NHS Foundation Trust, Birmingham

NHS Greater Glasgow and Clyde, Glasgow

Barts Health NHS Trust of Royal London Hospital, London

St George's University Hospitals NHS Foundation Trust, London

SM5 1AA

St Helier Hospital, Carshalton

All Listed Sponsors
lead

Vascular Therapies, Inc.

INDUSTRY