Status:
COMPLETED
The Study to Assess AMI Treated With Balloon Angioplasty.
Lead Sponsor:
Cordis US Corp.
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The main objective of this study is to assess the effectiveness and safety of the CYPHER™ (CYPHER SELECT™) (Sirolimus-eluting) stent in reducing the occurrence of a composite endpoint of target vessel...
Detailed Description
This is an international, multicenter (up to 52 sites), randomized, single-blind study in patients with an acute myocardial infarction treated with the CYPHER™ (Sirolimus-eluting) stent as compared to...
Eligibility Criteria
Inclusion
- Have prolonged, continuous (lasting at least 20 minutes) chest pain despite administration of nitrates and onset within 12 hours of randomization, and one of the following:
- ST segment elevation \>=1mm in standard leads and \>=2mm in 2 or more contiguous precordial leads with reciprocal ST depression
- New or presumably new left bundle branch block (LBBB)
- The culprit lesion must be identified on a de novo native coronary artery and an emergency angioplasty must be possible. The culprit site must be visualized before the stent implantation;
Exclusion
- Killip class \> 2 upon arrival to the cath-lab;
- Significant (\>50%) stenosis proximal or distal to the target lesion that might require revascularization or impede inflow or runoff;
- Evidence of massive thrombus in the infarct related artery distally to the culprit lesion;
- Documented left ventricular ejection fraction \<=30%;
- Target lesion is located in an arterial or venous by-pass graft;
- ECG documented evidence of prior myocardial infarction;
- Patient who received thrombolytic therapy for the current AMI before enrollment in this study.
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
715 Patients enrolled
Trial Details
Trial ID
NCT00232830
Start Date
October 1 2003
End Date
April 1 2009
Last Update
September 16 2009
Active Locations (2)
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1
HOPITAL COCHIN, René Descartes University
Paris, France, 75014
2
University of Freiburg, Albert-Ludwigs-Universitätskliniken
Freiburg im Breisgau, Germany, 79106