Prospective, Randomized, Multicenter Study to Assess the Safety and Effectiveness of the Orsiro Sirolimus-eluting Stent

BIOTRONIK-A Prospective, Randomized, Multicenter Study to Assess the Safety and Effectiveness of the Orsiro Sirolimus Eluting Stent in the Treatment of Subjects With up to Two de Novo Coronary Artery Lesions - IV

BIOFLOW-IV is a prospective, international, multicenter, randomised controlled trial. The purpose of this trial is to compare the Biotronik Orsiro drug eluting stent system with the Xience Prime / Xience Xpedition (Xience)drug eluting stent system in de novo coronary lesions. The study is powered for non-inferiority with respect to Target Vessel Failure(TVF)at 12 months.

Main Inclusion Criteria:

• Subject must provide written informed consent
• The target reference vessel diameter (RVD) is ≥ 2.50 mm and ≤ 3.75 mm assessed either visually or by online QCA.
• Target lesion length is ≤ 26 mm (assessed either visual estimate or by online QCA) and can be covered by one study stent
• Single de novo lesion with ≥ 50% and < 100% stenosis in up to 2 coronary arteries

Main Exclusion Criteria:

• Subject has evidence of myocardial infarction within 72 hours prior to the index procedure
• Planned intervention of non-target vessel(s) within 30 days after the index procedure
• Planned intervention of target vessel(s) after the index procedure
• Target lesion is located in the left main
• Target lesion is located in or supplied by an arterial or venous bypass graft
• Target lesion involves a side branch > 2.0 mm in diameter by visual estimate or by online QCA
• Proximal or distal to the target lesion located stenosis that might require future revascularization or impede run off