RecruitingNot ApplicableNCT07000045

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)


Sponsor

Annapoorna Kini

Enrollment

120 participants

Start Date

Oct 6, 2025

Study Type

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Intravascular lithotripsy and a medical device called Rotational atherectomy for people with coronary artery disease and coronary calcification. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEIntravascular lithotripsy

Intravascular lithotripsy device used for calcium modification in coronary lesions, using either operator-determined or maximum pulsed numbers for lesion preparation prior to stenting.

DEVICERotational atherectomy

Rotational atherectomy device used to debulk calcified nodules before IVL and stent implantation.


Locations(1)

Mount Sinai Hospital

New York, New York, United States

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NCT07000045


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