Intravascular Lithotripsy With or Without Rotational Atherectomy for Coronary Calcified Nodule Treatment

Exclusion Criteria

• •Cardiogenic shock at the time of procedure
• •Primary PCI for ST-segment elevation myocardial infarction (STEMI)
• •Pregnant, nursing, or childbearing potential without adequate contraception
• •Known allergy or contraindication to DAPT (aspirin, clopidogrel, prasugrel, ticagrelor)
• •Planned surgery within 6 months unless DAPT can be maintained
• •Life expectancy \<12 months due to a serious medical illness (e.g., advanced cancer, end-stage heart failure)
• •Severe kidney dysfunction (CrCl \<30 mL/min) without dialysis
• •Concurrent participation in another investigational study
• •Referral for coronary artery bypass grafting (CABG) after a heart team discussion
• •Angiographic evidence of thrombus at the target lesion
• •Angiographic evidence of significant dissection at the treatment site prior to intervention
• •Lesion with a previously placed stent within 10mm (visual estimate)
• •Last remaining vessel with severely compromised left ventricular function (LVEF \<30%)
• •Target lesion within a saphenous vein graft (SVG)