Intravascular Lithotripsy With or Without Rotational Atherectomy for Coronary Calcified Nodule Treatment
Trial Parameters
Brief Summary
The NODULE-SHOCK trial is a prospective, investigator-initiated, single-center, randomized controlled trial designed to compare the efficacy of intravascular lithotripsy (IVL) with or without rotational atherectomy (RA) in patients with coronary calcified nodules (Cohort A), and operator-determined vs maximum IVL pulses in patients with non-nodular severe coronary calcium (Cohort B).
Eligibility Criteria
Inclusion Criteria * Age ≥18 years who signed written informed consent * Presence of a clinical indication for coronary intervention * Patients undergoing PCI for a de novo calcified lesion with planned drug-eluting stent (DES) implantation * Native coronary artery with significant stenosis defined as: * ≥70% and \<100% stenosis on angiography, or * 50-70% stenosis with evidence of ischemia (positive stress test, FFR ≤ 0.8, or OCT minimal lumen area (MLA) ≤ 4.0 mm2) * Reference vessel diameter: ≥2.5 mm to ≤ 4.0 mm * Lesion length: ≥5mm * Moderate to severe calcification of the target lesion confirmed by angiography * Thrombolysis in Myocardial Infarction (TIMI) flow grade 3 at baseline 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) * Pl