Coronary Calcified Nodule Management With Rotational Atherectomy Plus Shockwave Intravascular Lithotripsy vs. Intravascular Lithotripsy Alone: A Prospective, Randomized Trial (NODULE-SHOCK)
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).
• 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