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Multi-Center Clinical Trial: Evaluation of Effectiveness and Safety

NCT00415961 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2009-01-09

No results posted yet for this study

Summary

This trial aims to demonstrate the non-inferiority of the CI-CMS-005 Coronary Stent System to the study device as well as to the TAXUS™ Express2™ Drug-Eluting Coronary Stent System in in-segment late lumen loss at 9 months after treatment of a single de novo lesion per vessel.

Conditions

  • Coronary Disease

Interventions

DEVICE

CoStar Paclitaxel Drug-Eluting Coronary Stent System

CoStar Paclitaxel Drug-Eluting Coronary Stent System

Sponsors & Collaborators

  • Getz Pharma

    collaborator INDUSTRY

  • Conor Medsystems

    lead INDUSTRY

Principal Investigators

  • Shigeru Saito, MD · ShonanKamakura General Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
95 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-11-30
Completion
2012-05-31

Countries

  • Japan

Study Locations

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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 NCT00415961 on ClinicalTrials.gov