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A study evaluating the safety and efficacy of the BioFreedomTM Biolimus A9TM coated Cobalt Chromium coronary stent system in patients at high risk of bleeding.
The objective of this study is to evaluate if the BioFreedomTM CoCr Drug Coated stent has a similar clinical safety and efficacy characteristics to the BioFreedomTM SS Drug Coated stent.
Primary Safety Endpoint: MACE, defined as a composite of cardiac death, MI and definite/probable ST at one year.
Primary Efficacy Endpoint: Clinically driven target lesion revascularization (TLR) at one year.