MedTrace Logo

Safety and Effectiveness Study of Combo Bio-engineered Sirolimus Eluting Stent

NCT00967902 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2016-03-29

No results posted yet for this study

Summary

To demonstrate the safety and effectiveness of the Combo Bio-engineered Sirolimus Eluting Stent (Combo Stent) compared to the Taxus® Liberté® Stent in the treatment of coronary artery lesions.

Conditions

  • Coronary Artery Lesions

Interventions

DEVICE

coronary stenting

Balloon dilatation of obstructive coronary artery disease with deployment of a metallic stent to scaffold the dilated lesion; stent incorporating sustained release of anti-proliferative agent to control neointimal proliferation and reocclusion; test device incorporates affinity surface for circulating EPCs

Sponsors & Collaborators

  • OrbusNeich

    lead INDUSTRY

Principal Investigators

  • Ian T Meredith, MBBS, PhD · Monash University

  • Stephan Windecker, MD · University of Bern

  • Alexandre Abizaid, MD · Inst Dante Pazzanese of Cardiology

  • Roxana Mehran, MD · CardioVascular Research Foundation

  • Alexandra Lansky, MD · CardioVascular Research Foundation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2011-07-31
Completion
2015-09-30

Countries

  • Australia

Study Locations

More Related Trials

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 NCT00967902 on ClinicalTrials.gov