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

Recruiting N/A Interventional Study
Coronary Artery Disease Coronary Calcification
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
120 (estimated)
Sponsor
Annapoorna Kini · Other
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About This Trial

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).

Trial Locations
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Eligibility Criteria
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…
Contacts

Keisuke Yasumura, MD

(212) 241-4181

keisuke.yasumura@mountsinai.org

CONTACT