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Recently presented retrospective analysis comparing none, moderate, and severely calcified coronary lesions showed that percutaneous coronary intervention (PCI) patients that have moderate/severely calcified coronary lesions have poorer outcomes than patients with none/mild calcified coronary lesions.
MACE study conducted by Cardiovascular Systems Inc. (CSI) is the first study that will prospectively monitor PCI outcomes in patients with varied degrees of calcification in coronary lesions. This study will enroll up to 500 subjects in up to 50 U.S. study sites. The objectives of the MACE study are to: 1) assess current standard of care treatment outcomes in none/mild (n=100), moderate (n=200), and severe (n=200) calcified coronary lesions. 2) Obtain financial data and procedure data to support reimbursement initiatives and health care economics analysis. Subjects scheduled for endovascular treatment involving stent deployment in de novo coronary lesions are qualified to be included in the study. Endovascular treatment is defined as treatment with commercially available devices that may include but is not limited to balloon, cutting balloon, Rotablator, etc. followed by the stent placement. The subjects will not be included in the study if 1) diagnosed with chronic renal failure unless under hemodialysis or has a serum creatinine level >2.5 mg/dl; 2) have evidence of current LVEF ≤25%; 3) have history of major cardiac intervention within 30 days, not including a PCI procedure for a staging purpose; 4) have uncontrolled insulin dependent diabetes.
The primary endpoint is to assess the current standard of care treatment when used to facilitate stent deployment in de novo, coronary lesions. This will be measured by a composite of major adverse cardiac events (MACE) at 30 days and 1-year post procedure. MACE is composed of cardiac death; myocardial infarction (MI) – defined as a CK-MB level > 3 times the upper limit of lab normal (ULN) value with or without new pathologic Q wave; and target vessel revascularization (TVR) – defined as revascularization at the target vessel (inclusive of the target lesion) after the completion of the index procedure. Secondary endpoints include procedural success and health economics.
An interim analysis of acute outcomes will be presented on up to 50 subjects that have completed the discharge visit.