BIOFLOW-INDIA Safety and Clinical PerFormance of the Drug Eluting ORSIRO Stent in Single de Novo Coronary Artery Lesions

BIOTRONIK-Safety and Clinical PerFormance of the Drug Eluting ORSIRO Stent in the Treatment of Patients With Single de Novo Coronary Artery Lesions in an Indian Population

The objective of this clinical investigation is to assess the safety and clinical performance of the Orsiro Limus Eluting Stent System in Indian subjects with single de-novo coronary artery lesions.

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