Intravascular Lithotripsy With or Without Rotational Atherectomy for Coronary Calcified Nodule Treatment
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAnnapoorna Kini
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).
Eligibility criteria
Qualifiers
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
≥70% and <100% stenosis on angiography, or
Disqualifiers
Cardiogenic shock at the time of procedure
Primary PCI for ST-segment elevation myocardial infarction (STEMI)
Pregnant, nursing, or childbearing potential without adequate contraception
Known allergy or contraindication to DAPT (aspirin, clopidogrel, prasugrel, ticagrelor)
Trial design
Treatments tested in this trial
- Intravascular lithotripsy
- Rotational atherectomy
Treatment groups
120 Participants
are divided into 4 treatment groupsSponsors and collaborators
Annapoorna Kini
Lead sponsor
Icahn School of Medicine at Mount Sinai
Sponsor institution
Source ClinicalTrials.gov