Clinical Research Directory

Inclusion Criteria: * Subjects with native coronary artery disease (including stable or unstable angina and NSTEMI) suitable for PCI. * The lesion must be crossable with the study guide wire. * The target vessel reference diameter must be ≥ 2.5mm and ≤ 4.0 mm. * The target lesion must have evidence of severe calcium deposit at the lesion site based on the protocol criterion. * Subject or legally authorized representative, signs a written Informed Consent form to participate in the study, prior to any study-mandated procedures. * Male or female, age above or equal to 18 years at the time of signing informed consent. Further inclusion criteria may apply Exclusion Criteria: * Inability to understand the study or a history of non-compliance with medical advice. * Unwilling or unable to sign the Informed Consent Form (ICF). * History of any cognitive or mental health status that would interfere with trial participation. * Male or female, age under 18 years at the time of signing informed consent. * Female subjects who are pregnant or planning to become pregnant within the study period. * Subject has a known sensitivity to contrast media, which cannot be adequately pre-medicated. * Subject has evidence of an active infection on the day of the procedure requiring oral or intravenous antibiotics. * Limited long term prognosis due to other conditions. * Subjects in cardiogenic shock or with decompensated heart failure (NYHA class IV). * Subject diagnosed with chronic kidney disease stage 4 or greater (eGFR \<30). * Most recent left ventricular ejection fraction ≤ 20%. * Subject is an acceptable candidate for coronary artery bypass surgery. * The target vessel reference diameter is under 2.0 mm. * Target lesion is located in or supplied by an arterial or venous bypass graft. * The target vessel has angiographically visible or suspected thrombus. * The target lesion is in an in-stent restenosis. * Subject has received a heart transplant. * Subject has major valve disease and underwent intervention within 30 days prior to randomization. Further exclusion criteria may apply