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RECRUITING
NCT07000045
NA

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

Sponsor: Annapoorna Kini

View on ClinicalTrials.gov

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).

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2025-10-06

Completion Date

2027-12-31

Last Updated

2025-10-09

Healthy Volunteers

No

Interventions

DEVICE

Intravascular 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.

DEVICE

Rotational 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