Status:
COMPLETED
Cobalt Chromium Stent With Antiproliferative for Restenosis II Trial (COSTAR II)
Lead Sponsor:
Cordis US Corp.
Collaborating Sponsors:
Conor Medsystems
Conditions:
Coronary Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of the investigational stent CoStar™ Paclitaxel-Eluting Coronary Stent- a reservoir based DES system in comparison to a surface co...
Detailed Description
Non -inferiority in 8-month Major Adverse Cardiac Events (MACE) and in-segment late lumen loss at 9 months between the CoStar™ Paclitaxel-Eluting Coronary Stent System and the TAXUS™ Express2™ Drug El...
Eligibility Criteria
Inclusion
- General
- 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 :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
1701 Patients enrolled
Trial Details
Trial ID
NCT00165035
Start Date
May 1 2005
End Date
July 1 2011
Last Update
August 4 2011
Active Locations (2)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27705
2
Christ Linder
Cincinnati, Ohio, United States, 45219