The Study to Assess AMI Treated With Balloon Angioplasty.

Study Overview
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Brief Summary
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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 failure (TVF) in subjects treated for acute myocardial infarction as compared to a bare metal stent.

Detailed Description
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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 the bare stents. Patients with de novo native coronary artery lesions will be treated with the CYPHER™ (Sirolimus-eluting) stent or a bare stent. Subjects will be followed at 30 days, 6 months and at 1, 3, 4 and 5 years post-procedure. 200 subjects will have an angiographic follow-up at 8 months.

Official Title
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Trial to Assess the Use of the Cypher TM Stent in Acute Myocardial Infarction Treated With Balloon Angioplasty

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: drug-eluting stent
* Device: bare-metal stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Cypher Sirolimus-eluting Coronary Stent | Device: drug-eluting stent<br>* Cypher Sirolimus-eluting Coronary Stent<br>|
| Active Comparator: 2<br>Bare-metal stent | Device: bare-metal stent<br>* any bare-metal stent brand<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of target vessel failure (TVF) defined as target vessel revascularization, recurrent myocardial infarction, or cardiac death that could not be clearly attributed to a vessel other than the target vesselpost-procedure. |  | 1 and 6 months and at 1, 3, 4, and 5 years post-procedure. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cardiac death |  | 1, 3, 4 and 5 years post-procedure | 
| recurrence of myocardial infarction |  | 1, 3, 4 and 5 years post-procedure | 
| revascularization of the target vessel (TVR) |  | 1, 3, 4 and 5 years post-procedure | 
| recurrence of ischemia |  | 1, 3, 4 and 5 years post-procedure |