Multi-center Prospective Study to Evaluate Outcomes of the Moderate to Severely Calcified Coronary Lesions (MACE)

Inclusion Criteria

• Subjects must be at least 18 years of age.
• Subjects must be scheduled for percutaneous coronary revascularization involving stent deployment in de novo coronary lesions. Percutaneous coronary revascularization is defined as treatment with commercially available devices that may include but not limited to balloon angioplasty, cutting balloon, rotablation, etc. followed by the stent placement.
• Subjects CK-MB must be less than or equal to the upper limit of lab normal value within eight (8) hours prior to procedure. If CK-MB results are not yet available prior to initiating procedure, subjects Troponin I or Troponin T must be less than or equal to the upper limit of lab normal value within eight (8) hours prior to the procedure.
• The target lesion must be a de novo coronary lesion that has not been previously treated with any interventional procedure.
• The target vessel must be a native coronary artery with:
• A stenosis ≥ 70% and 2.5 mg/dl.
• History of major cardiac intervention within 30-day, not including a PCI procedure for a staging purpose.
• Evidence of heart failure by one of the following:

i. Left Ventricular Ejection Fraction (LVEF) ≤ 25% ii. New York Heart Association (NYHA) class III or IV iii. Clinical symptoms

• History of a stroke or transient ischemic attack (TIA) within six (6) months
• Active peptic ulcer or upper gastrointestinal (GI) bleeding within six (6) months.
• History of bleeding diathesis or coagulopathy or intention to refuse blood transfusion if one should become necessary.
• Concurrent medical condition with a life expectancy of < 36 months.
• History of immune deficiency.
• Uncontrolled insulin dependent diabetes.
• Evidence of active infections on the day of the index procedure.
• Subject has planned cardiovascular intervention within 60 days post index procedure.
• Subject with angiographically confirmed evidence of more than two (2) lesions within one (1) vessel or more than one (1) vessel requiring intervention, unless the treatment is staged. See Section 10.1 for more details.
• Target lesion is located in a native vessel distal to anastomosis with a saphenous vein graft or Left Internal Mammary Artery/ Right Internal Mammary Artery (LIMA/RIMA) bypass.
• Target vessel has angiographically visible or suspected thrombus.
• Target vessel appears to be/is excessively tortuous at baseline.
• Target lesion is an ostial location (within 5mm of ostium) or an unprotected left main lesion.
• Target lesion is a bifurcation (side branch ≥ 1.5mm).
• Treatment of the target lesion with the CSI coronary Diamondback Orbital Atherectomy System (OAS).