• Subject is ≥18 years of age

• Subject is able and willing to comply with all assessments in the study.

• Subjects with native coronary artery disease including stable angina or following stabilization after acute coronary syndromes (ACS) for non-emergent percutaneous coronary intervention (PCI)

• Biomarkers (troponin) must be:

∙ less than or equal to the upper limit of lab normal within 24 hours prior to the procedure or may be drawn from the side port of the sheath at the time of index if the PCI is a non-emergent procedure and has stable angina (result will not be known prior to procedure); OR

‣ if above the upper limit of lab normal, biomarker result must be less than 5 times the upper limit of lab normal within 24 hours prior to the procedure and the following criteria must be met: • The procedure must not be emergent and the subject cannot have angina at rest.

• Left ventricular ejection fraction (LVEF) \>30% within 6 months (note: in the case of an event (MI or Revascularization) the LVEF must be taken post-event and in the case of multiple assessments of LVEF, the measurement closest to enrollment will be used for this criterion; may be assessed at time of index procedure).

• Subject, or legally authorized representative, signs a written Informed Consent form to participate in the study, prior to any study-mandated procedures.

• Estimated life expectancy \>1 year.

• Lesions in non-target vessels requiring PCI may be treated either:

∙ \>30 days prior to the study procedure if the procedure was unsuccessful or complicated; OR

‣ \>24 hours prior to the study procedure if the procedure was successful and uncomplicated (defined as a final lesion angiographic diameter stenosis \<30% and TIMI 3 flow (visually assessed) for all non-target lesions and vessels without perforation, cardiac arrest or need for defibrillation or cardioversion or hypotension/heart failure requiring mechanical or intravenous hemodynamic support or intubation, and no evidence of elevated biomarkers post-procedure; OR

‣ \>30 days after the study procedure

• Angiographic Inclusion Criteria

• The target lesion must be a de novo coronary lesion that has not been previously treated successfully with any interventional procedure

⁃ Single de novo target lesion stenosis of protected LMCA, or LAD, RCA or LCX (or of their branches)

⁃ The target vessel reference diameter must be ≥2.5 mm and ≤4.0 mm

⁃ The target lesion must meet one of the following criteria:

• Target lesion stenosis \>90% up to 40 mm in length and evidence of moderate or severe calcification at the lesion site. Moderate calcification defined as angiography with densities noted only during the cardiac cycle prior to contrast injection; severe calcification defined as angiography with fluoroscopic radio-opacities noted without cardiac motion prior to contrast injection involving both sides of the arterial wall; OR

∙ Chronic total occlusion presenting with J-CTO score of 1 with evidence of calcification and occlusion length up to 20 mm.

⁃ Guidewire must be in true lumen, distal to the lesion, and not subintimal, prior to insertion of Shockwave Javelin Coronary IVL catheter (antegrade wire technique only)