Annapoorna Kini
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).
The trial consists of two cohorts: * Patients with calcified nodules (CN) (Cohort A) * Patients with non-nodular severe coronary calcium (Cohort B) Randomization will occur as follows: * Rotational atherectomy followed by intravascular lithotripsy (IVL) or IVL alone for lesion preparation prior to stenting (Cohort A). * Operator-determined or maximum IVL pulses prior to stenting. (Cohort B) The trial is designed to compare two calcium modification strategies in each cohort with regard to the primary endpoints of post-procedural minimum stent area assessed by optical coherence tomography at…
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 c…
Intravascular lithotripsy device used for calcium modification in coronary lesions, using either operator-determined or maximum pulsed numbers for lesion preparation prior to stenting.
Rotational atherectomy device used to debulk calcified nodules before IVL and stent implantation.
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