Status:

TERMINATED

Multi-Center Clinical Trial: Evaluation of Effectiveness and Safety

Lead Sponsor:

Conor Medsystems

Collaborating Sponsors:

Getz Pharma

Conditions:

Coronary Disease

Eligibility:

All Genders

20-95 years

Phase:

NA

Brief 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 ...

Detailed Description

This is a complementary, multi-center, open-label, single-arm trial investigating angiographic and clinical patient outcomes in Japan. Historical data from the 2-arm randomized COSTAR II trial will be...

Eligibility Criteria

Inclusion

  • General Inclusion Criteria
  • Eligible for percutaneous coronary intervention (PCI)
  • Documented stable or unstable angina pectoris (Class I, II, III or IV), documented ischemia, or documented silent ischemia
  • Documented LVEF ≥25% within the last 6 weeks.
  • Eligible for coronary artery bypass graft surgery (CABG)

Exclusion

  • General

Key Trial Info

Start Date :

November 1 2006

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

May 1 2012

Estimated Enrollment :

120 Patients enrolled

Trial Details

Trial ID

NCT00415961

Start Date

November 1 2006

End Date

May 1 2012

Last Update

January 9 2009

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Shonan Kamakura General Hospital

Kamakura, Japan, 247-8533