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Recruiting NCT07000045

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

Conditions: Coronary Artery Disease, Coronary Calcification

Sex: All

Ages: 18 Years – N/A

Healthy volunteers: No

Phase: NA

Enrollment: 120

Sponsor: Annapoorna Kini

Location: Mount Sinai Hospital New York New York

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 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 as: * ≥70% and \

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07000045). StuddyBuddy aggregates publicly available trial information.