Coronary Orbital Atherectomy System Study

This is a prospective, single-arm, multi-center, global study designed to evaluate performance of the Diamondback 360® Coronary Orbital Atherectomy System Micro Crown (OAS Micro Crown) in treating de novo, severely calcified coronary lesions.

Inclusion criteria

• Subjects must be 18 or older.
• Subjects must have a clinical indication for coronary intervention.
• CK and CK-MB must be less than or equal to the upper limit of lab normal value within 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.
• The target vessel reference diameter must be >= 2.5mm and <= 4.0 mm.
• The lesion length must not exceed 40 mm.
• The target vessel must have a TIMI flow three (3) at baseline.
• The target lesion must have fluoroscopic, IVUS or OCT evidence of severe calcium deposit at the lesion site.
• The lesion must be crossable with the study guide wire.

Exclusion criteria

• Inability to understand the study requirements or has a history of non-compliance with medical advice.
• Unwilling to sign the COAST ICF.
• History of any cognitive or mental health status that would interfere with study participation.
• Currently enrolled in any other pre-approval investigational study.
• Female subjects who are pregnant or planning to become pregnant within the study period.
• Known hypersensitivity or contraindication to aspirin, heparin, ticlopidine or clopidogrel without adequate alternative medications.
• Known sensitivity to contrast media, which cannot be adequately pre-medicated.
• Diagnosed with chronic renal failure unless under hemodialysis, or has a serum creatinine level > 2.5 mg/dl.
• Experienced acute MI, STEMI or non-STEMI: CK-MB greater than the upper limit of lab normal value, within 30 days prior to index procedure.
• History of major cardiac intervention within 30 days.
• Evidence of heart failure
• History of a stroke or TIA within six (6) months.
• Active peptic ulcer or upper 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 < 12 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 is not an acceptable candidate for emergent CABG surgery.
• Subject with known allergy to atherectomy lubricant components such as soybean oil, egg yolk phospholipids, glycerin and sodium hydroxide.
• Subject with angiographically confirmed evidence of more than one (1) lesion requiring intervention, unless the treatment of the lesions is staged.
• Target lesion is located in a native vessel distal to anastomosis with a saphenous vein graft or LIMA/RIMA bypass.
• Target vessel has other lesions with greater than 50% diameter stenosis based on visual estimate or on-line QCA.
• Target vessel has angiographically visible or suspected thrombus.
• Target vessel has a stent from previous PCI.
• Target vessel appears to be or is excessively tortuous at baseline.
• Target lesion is an ostial location (within 5 mm of ostium) or an unprotected left main lesion.
• Target lesion is a bifurcation.
• Target lesion has a ≥ 1.5 mm side branch.
• Angiographic evidence of a dissection prior to initiation of OAD.