Clinical Trial

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

Study acronym: NODULE-SHOCK
Recruiting
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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).
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2025-05-23; most recent amendment 2026-07-10.
Status change: Not Yet Recruiting → Recruiting 2025-10-07
Trial Details
NCT Number NCT07000045
Lead Sponsor Annapoorna Kini
Conditions Coronary Artery Disease, Coronary Calcification
Enrollment 120 participants
Start Date 2025-10-06
Primary Completion 2026-12-31 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-07-13