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

NCT02513303 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 269

Last updated 2025-10-09

Study results available
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Summary

The objective of this study is to evaluate efficacy and safety outcomes following use of the Sirolimus-eluting Collagen Implant (SeCI) in subjects undergoing surgical creation of an AV fistula for vascular access (index procedure).

Conditions

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.

Sponsors & Collaborators

  • Vascular Therapies, Inc.

    lead INDUSTRY

Principal Investigators

  • Sriram Iyer, MD · Vascular Therapies, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2021-06-30
Completion
2021-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02513303 on ClinicalTrials.gov