BIOFLOW-INDIA Safety and Clinical PerFormance of the Drug Eluting ORSIRO Stent in Single de Novo Coronary Artery Lesions
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Ages Eligible for Study:
18 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Main Inclusion Criteria:
Subject has provided a written informed consent
Single de novo lesion with ≥ 50% and <100% stenosis in up to 2 coronary arteries
The target lesion length is ≤ 26 mm
The target reference vessel diameter is ≥ 2.0 mm and ≤ 4.0 mm
Main Exclusion Criteria:
Evidence of myocardial infarction within 72 hours prior to index procedure
Unprotected left main coronary artery disease (stenosis >50%)
Three-vessel coronary artery disease at time of procedure Thrombus in target vessel
Target lesion involves a side branch > 2.0 mm in diameter
Heavily calcified lesion
Target lesion is located in or supplied by an arterial or venous bypass graft