NCT02513303View on ClinicalTrials.gov

Trial to Evaluate the Sirolimus-Eluting Collagen Implant on AV Fistula Outcomes

PHASE3CompletedINTERVENTIONAL
Enrollment

269

Participants

Timeline

Start Date

November 30, 2015

Primary Completion Date

June 30, 2021

Study Completion Date

June 30, 2021

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

Sirolimus

A single dose of sirolimus delivered locally

PROCEDURE

AV Fistula Surgery

AV Fistula Surgery

DEVICE

Sirolimus-eluting Collagen Implant (SeCI)

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 (4)

18017

Northeast Clinical Research Center, Bethlehem

35805

Nephrology Consultants, LLC, Huntsville

85012

AKDHC Medical Research Service, Phoenix

92025

San Diego Institute of Medical Research, Escondido

All Listed Sponsors
lead

Vascular Therapies, Inc.

INDUSTRY

NCT02513303 - Trial to Evaluate the Sirolimus-Eluting Collagen Implant on AV Fistula Outcomes | Biotech Hunter | Biotech Hunter