Study of the Orsiro Drug Eluting Stent System

BIOTRONIK-Safety and Clinical PerFormance of the Drug ELuting Orsiro Stent in the Treatment of Subjects With Single de Novo Coronary Artery Lesions - II

The purpose of this study is to compare the BIOTRONIK Orsiro Drug Eluting Stent System with the Abbott Xience Prime™ Drug Eluting Stent System with respect to in-stent Late Lumen Loss in a non-inferiority study in de novo coronary lesions at 9 months.

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 ≥ 2.25 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