Intravascular Lithotripsy in Comparison to Rotational Atherectomy: An Evaluation by OFDI

The ICARE trial will aim to assess the efficacy of rotational atherectomy by Rotablator and Intravascular Lithotripsy by C2 Shockwave Medical® (IVL) in a randomized fashion in highly calcified lesions measured by final minimal stent area (MSA) on Optical Frequency Domain Imaging (OFDI). The investigator hypothesize that there will be no significant difference in final MSA in OFDI between the two groups after angioplasty with a last generation drug eluting stent ULTIMASTER TANSEI.

Inclusion Criteria: 1. Patient ≥ 18 years old 2. Subjects with native coronary artery disease (including stable or unstable angina and silent ischemia) suitable for Percutaneous Coronary Intervention (PCI) 3. For patients with unstable ischemic heart disease, biomarkers (troponin or CK-MB) must be less than or equal to the upper limit of the lab (URL) normal within 12 hours prior to the procedure 4. The target lesion must be a de novo coronary lesion that has not been previously treated with any interventional procedure 5. Single de novo target lesion stenosis of protected LMCA, or LAD, RCA, or LCX (or of their branches) with: 1. Stenosis of ≥70% and \