Modification of Coronary Calcium With Laser Based Intravascular Lithotripsy for Coronary Artery Disease (FRACTURE)

The FRACTURE Trial is a prospective, non-randomized, single-arm, multicenter, interventional study in US and international centers.

Key Inclusion Criteria: * Subject is ≥18 years of age; * Subjects with native coronary artery disease (including stable or unstable angina and silent ischemia) suitable for Percutaneous Coronary Intervention (PCI); * For patients with unstable ischemic heart disease, a local site-based biomarker (preferably troponin or hs-troponin) must be less than or equal to the upper limit of lab normal (ULN) within 12 hours prior to the study procedure; * For patients with stable ischemic heart disease, CK-MB will be drawn at the time of the study procedure from the side port of the sheath; results need not be analyzed prior to enrollment, but must be less than or equal to the upper limit of lab normal (ULN); * Single de novo target lesion stenosis of protected LMCA, or LAD, RCA, or LCX (or of their branches) with: * Stenosis of ≥70% and \