Intravascular Lithotripsy With or Without Rotational Atherectomy for Coronary Calcified Nodule Treatment
Coronary Calcified Nodule Management With Rotational Atherectomy Plus Shockwave Intravascular Lithotripsy vs. Intravascular Lithotripsy Alone: A Prospective, Randomized Trial (NODULE-SHOCK)
Annapoorna Kini
120 participants
Oct 6, 2025
INTERVENTIONAL
Conditions
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
Plain Language Summary
Simplified for easier understanding
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Interventions
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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07000045