• Subject must be at least 18 years of age.

• Subject must sign and date a written informed consent form before any study-specific tests or procedures are performed.

• Subject is able and willing to comply with all protocol requirements.

• Subject has native coronary artery disease (including stable or unstable angina and silent ischemia) suitable for PCI.

• For subject with unstable ischemic heart disease, cardiac biomarker (troponin) must be less than or equal to the upper reference limit (URL) within 12 hours prior to the procedure.

• For subject with stable ischemic heart disease, blood for cardiac biomarkers may be drawn prior to the procedure or at the time of the procedure from the side port of the sheath.

⁃ 6a. If drawn prior to the procedure, cardiac biomarker (troponin) must be less than or equal to the URL within 12 hours prior to the index procedure.

⁃ 6b. If drawn at the time of the procedure from the side port of the sheath prior to any intervention, cardiac biomarker results need to be analyzed and resulted prior to registering the subject into the study.

⁃ 7\) Left ventricular ejection fraction (LVEF) ≥ 25% within 6 months (note: in the case of multiple assessments of LVEF, the measurement closest to enrollment will be used for these criteria; may be assessed at time of index procedure).

⁃ 8\) Lesions in non-target vessels requiring PCI may be treated either: a. \>30 days prior to the study procedure if the procedure was unsuccessful or complicated; or b. \>24 hours prior to the study procedure if the procedure was successful and uncomplicated; or c. \>30 days after the study procedure (in 1 or 2 non-target vessels).

⁃ Anatomic Inclusion Criteria

⁃ Anatomic inclusion criteria are applied at the time of cardiac catheterization for PCI by the investigator and are visually assessed by angiography. The anatomic inclusion criteria include the following:

• The target lesion must be a single de novo coronary lesion that has not been previously treated with ANY interventional procedure.

• Single de novo target lesion stenosis of protected left main coronary artery (LMCA), or left anterior descending artery (LAD), right coronary artery (RCA), left circumflex artery (LCX), or ramus intermedius (RI), or of their branches with: a. Stenosis of ≥70% and \<100% or b. Stenosis ≥50% and \<70% with evidence of ischemia via positive stress test, or fractional flow reserve (FFR) value ≤0.80, or RFR/iFR \<0.89 (or any other non-hyperemic pressure index), or IVUS or OCT minimum lumen area ≤4.0 mm\^2

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

• The lesion length must not exceed 36 mm. 4a) Tandem lesions are allowed and considered one lesion if they are \<5 mm apart and as long as the total lesion length does not exceed 36 mm.

• The target vessel must have TIMI grade 3 flow at baseline; may be assessed after pre-dilatation.

• Evidence of calcification at the lesion site by, a. Angiography, with fluoroscopic radiopacities noted as severe (radiopacities noted without cardiac motion before contrast injection compromising both sides of the arterial lumen) OR b. IVUS or OCT, with presence of ≥270 degrees of calcium on at least 1 cross section.

• Ability to pass a 0.014 guide wire across the lesion.