Page 8 - biotronik_BIOFLOW-I

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Patient eligibility
Inclusion Criteria
Patient is шϭϴ years old
Clinical evidence of ischemic heart disease
and / or a positive functional study.
Documented stable angina pectoris, or
documented silent ischemia
Single de noǀo lesion ǁith ш5Ϭ% and <ϵϬ%
stenosis in 1 coronary artery
Exclusion Criteria
Documented left ventricular ejection
fraction ;LVEFͿ ч 3Ϭ%
Unstable angina pectoris (Braunwald Class
A I-III)
Three-vessel coronary artery disease
Evidence of myocardial infarction within
72 hours prior to the index procedure
Total occlusion (TIMI 0 or 1)
Target lesion is located in or supplied by
an arterial or venous bypass graft
Target lesion involves a side branch
>2.0mm in diameter
Unprotected Left main coronary artery
disease (stenosis >50%)