A Continuation in the Clinical Evaluation of the Abbott Vascular Everolimus-Eluting Bioresorbable Vascular Scaffold in the Treatment of Subjects With de Novo Native Coronary Artery Lesions

Bioresorbable Vascular Solutions Everolimus Eluting Coronary Scaffold System (BVS EECSS). Percutaneous Coronary Intervention (PCI) is commonly known as coronary angioplasty. Typically, PCI is performed by threading a slender balloon-tipped tube, a catheter, from an artery in the groin to a trouble spot in an artery of the heart. The balloon is then inflated, compressing the plaque and dilating (widening) the narrowed coronary artery so that blood can flow more easily. During PCI for this study, the BVS EECSS is then placed in the coronary artery to support the previously narrowed area. The BVS EECSS will remain in place until the bioresorbtion process is complete, your physician will discuss this process with you. The duration of the PCI procedure will depend on many factors, and is typically less than 2 hours. Your physician will discuss those factors and the length of your procedure with you. Optical Coherence Tomography (OCT) subgroup definition: - A subgroup of up to 50 subjects who: - Have their procedures performed at selected investigational sites with OCT capability; and - Receive planned overlapping BVS treatment of the target lesion. - The need for planned overlapping of BVS will be determined by the investigator up to the time of the index procedure. - Angiography, Intravascular Ultrasound (IVUS) and OCT are required for all subjects in the OCT subgroup post-procedure and at 2-year follow-up Multi-Slice Computed Tomography subgroup definition: - A subgroup of up to 100 subjects who: - Have their procedures performed at selected investigational sites having both OCT and MSCT capability; and - Receive at least one BVS EECSS in the target lesion. MSCT imaging and clinical follow-up at 18 months is required for all subjects in the MSCT subgroup.