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Study endpoints
Primary Endpoint
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In-stent late lumen loss at 9 months by QCA
Secondary Endpoints
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In-stent and in-segment binary restenosis rate at 4 and 9 months post procedure
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Clinically driven target lesion revascularization (TLR) at 1, 4 and 9 months and at 1, 2 and 3
years post-procedure
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Composite of cardiac death, MI attributed to the target vessel and clinically driven target
lesion revascularization at 1, 4 and 9 month post-procedure, and yearly up to 3 years
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Stent thrombosis at 1, 4 and 9 months, and at 1, 2 and 3 years post-procedure.
Definitions
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Lesion Treatment Success is defined as the attainment of <30% residual stenosis by offline
QCA using any percutaneous method
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Device Success defined as achievement of a final residual diameter stenosis of <30% by
offline QCA, using the assigned device only