A Post-approval Study of the Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System
Phase: NA
Conditions: Coronary Artery Disease
Sponsor: Medtronic Vascular

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The term acute myocardial infarction (MI) should be used when there is 
evidence of myocardial necrosis in a clinical setting consistent with acute 
myocardial ischemia. Under these conditions any one of the following criteria 
meets the diagnosis for MI: 
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Detection of a rise and/or fall of cardiac biomarker values [preferably 
cardiac troponin (cTn)] with at least one value above the 99th percentile 
upper reference limit (URL) and with at least one of the following: 
x
Symptoms of ischemia. 
x
New or presumed new significant ST-segment-T wave (ST-T) 
changes or new left bundle branch block (LBBB). 
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Development of pathological Q waves in the ECG. 

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Imaging of evidence of new loss of viable myocardium or new 
regional wall motion abnormality.  
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autopsy.  
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Cardiac death with symptoms suggestive of myocardial ischemia and 
presumed new ischemic ECG changes or new LBBB, but death occurred 
before cardiac biomarkers were obtained, or before cardiac biomarker 
values would be increased.  
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Percutaneous coronary intervention (PCI) related MI is arbitrarily defined 
by elevation of cTn values (>5 x 99th percentile URL) in patients with 
normal baseline values (ч99th percentile URL) or a rise in cTn values >20% if 
the baseline values are elevated and are stable or falling. In addition, either 
(i) symptoms suggestive of myocardial ischemia or (ii) new ischemic ECG 
changes or (iii) angiographic findings consistent with a procedural 
complication or (iv) imaging demonstration of new loss of viable 
myocardium or new regional wall motion abnormality are required.  
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angiography or autopsy in the setting of myocardial ischemia and with a 
rise and/or fall of cardiac biomarker values with at least one value above 
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