A CERC company

BIOFREEDOM STEMI REGISTRY

Brief summary: BioFreedom Stemi Registry is a prospective, multicenter, fully observational post market registry designed to enroll 1000 STEMI patients at 15 centers in 7 Asian countries where the BioFreedom™ BA9™ (SS) DCS is available for clinical use. All enrolled patients will be followed up for 1 year. Primary endpoints Target Lesion Failure (TLF) defined as composite of cardiovascular death, target-vessel related myocardial infarction (Q-wave and non-Q-wave), or ischemia-driven target lesion revascularization within 12 months (device-oriented outcome per ARC2 definitions) CERC Asia Services Project Management Site Start-up Regulatory Submissions Contracts and payments Management Monitoring Safety Annual Reporting Organization of CEC CERC Services : Data Management/EDC Corelab (Events)   Countries Hong Kong, Malaysia, Singapore, South Korea, Taiwan, Thailand, Vietnam Center number : 15 centers + 2 satellite...