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To assess the long-term safety and efficacy of the Xposition S stent (self-expanding sirolimus-eluting stent with a durable polymer coating) in the treatment of unprotected left main coronary artery disease.
Primary clinical endpoint:
Target Lesion Failure at 12 months post-procedure. TLF is defined as cardiac death, Myocardial Infarction (MI, WHO Extended Definition) not attributable to a non-target vessel, or clinically driven Target Lesion Revascularization (TLR) by percutaneous or surgical methods.
Primary efficacy endpoint:
Angiographic success: placement of the stent as intended at the target lesion with achievement of <20% final residual stenosis of the target lesion (mean along the target lesion length (main branch) determined by visual estimation), with TIMI 3 flow in main branch.