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Key inclusion and exclusion criteria
Key inclusion criteria
Diagnosis of angina pectoris or silent ischemia
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Single target lesion in a native vessel
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Reference vessel diameter between 2.0 - 5.0 mm
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Diameter stenosis between 50 - 100 %
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Key exclusion criteria
Unfavorable clinical condition (MI, elevated CK, etc.)
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Angiographic evidence of thrombus
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Stenosis greater than 50 % proximal or distal to target lesion
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Prior coronary intervention to the target vessel
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