Calcium Reduction by Orbital Atherectomy in Western Europe

Inclusion Criteria: * De novo significant native coronary artery lesion * The target lesion must have evidence of severe calcification: 1) presence of radiopacities noted without cardiac motion prior to contrast injection involving both sides of the arterial wall with calcification length of at least 15 mm and extend partially into the target lesion. 2) OR presence of ≥ 270° of calcium or lumen protruding calcified nodules at \>1 cross section by intravascular imaging (OCT) * The target vessel reference diameter ≥ 2.5 mm and ≤ 4.0 mm and lesion must not exceed 40 mm in length Exclusion Criteria: * Left main disease * Prior stenting of the target vessel * Target lesion has thrombus or dissection * Known left ventricular ejection fraction LVEF ≤ 25% * Diagnosed with chronic renal failure (GFR \< 30 ml/min) * Confirmed pregnancy * Life expectancy \< 12 months * Coronary anatomy that prevents delivery of OCT catheter * Known allergy to soybean oil, egg yolk phospholipids, glycerin or sodium hydroxide