[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100053354":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":39,"centralContacts":43,"locations":49,"responsibleParty":70,"collaborators":34,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":76,"sex":82,"minAge":83,"maxAge":34,"enrollmentInfo":84,"targetDuration":34,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":94,"overallStatus":52,"whyStopped":34,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"Icahn School of Medicine at Mount Sinai","OTHER",[8,15,20,24],{"label":9,"type":10,"description":11,"interventionNames":12},"RA + IVL (Cohort A)","EXPERIMENTAL","Patients with coronary calcified nodules treated with rotational atherectomy followed by intravascular lithotripsy for lesion preparation prior to stenting.",[13,14],"Device: Intravascular lithotripsy","Device: Rotational atherectomy",{"label":16,"type":17,"description":18,"interventionNames":19},"IVL alone (Cohort A)","ACTIVE_COMPARATOR","Patients with coronary calcified nodules treated with intravascular lithotripsy alone for lesion preparation prior to stenting.",[13],{"label":21,"type":10,"description":22,"interventionNames":23},"Maximum IVL pulses (Cohort B)","Patients with non-nodular severe coronary calcium treated with intravascular lithotripsy prior to stenting using the maximum number of pulses per manufacturer's instructions.",[13],{"label":25,"type":17,"description":26,"interventionNames":27},"Operator-determined IVL pulses (Cohort B)","Patients with non-nodular severe coronary calcium treated with intravascular lithotripsy prior to stenting using a pulse number determined at the operator's discretion.",[13],[29,35],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"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.",[16,21,25,9],null,{"type":30,"name":36,"description":37,"armGroupLabels":38,"otherNames":34},"Rotational atherectomy","Rotational atherectomy device used to debulk calcified nodules before IVL and stent implantation.",[9],[40],{"name":41,"affiliation":5,"role":42},"Annapoorna S Kini, MD","PRINCIPAL_INVESTIGATOR",[44],{"name":45,"role":46,"phone":47,"phoneExt":34,"email":48},"Keisuke Yasumura, MD","CONTACT","(212) 241-4181","keisuke.yasumura@mountsinai.org",[50],{"facility":51,"status":52,"city":53,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"Mount Sinai Hospital","RECRUITING","New York","10029","United States","US",{"type":58,"coordinates":59},"Point",[60,61],-74.00597,40.71427,{"lat":61,"lon":60},[64,66,68],{"name":41,"role":46,"phone":47,"phoneExt":34,"email":65},"annapoorna.kini@mountsinai.org",{"name":45,"role":46,"phone":67,"phoneExt":34,"email":48},"212-241-4181",{"name":69,"role":42,"phone":34,"phoneExt":34,"email":34},"Annapoorna S Kini",{"type":71,"investigatorFullName":72,"investigatorTitle":73,"investigatorAffiliation":5,"oldNameTitle":34,"oldOrganization":34},"SPONSOR_INVESTIGATOR","Annapoorna Kini","Professor","100053354","intravascular-lithotripsy-with-or-without-rotational-atherectomy-for-coronary-calcified-nodule-treatment-100053354",false,"NCT07000045","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)","NODULE-SHOCK","Inclusion Criteria\n\n* Age ≥18 years who signed written informed consent\n* Presence of a clinical indication for coronary intervention\n* Patients undergoing PCI for a de novo calcified lesion with planned drug-eluting stent (DES) implantation\n* Native coronary artery with significant stenosis defined as:\n* ≥70% and \\\u003C100% stenosis on angiography, or\n* 50-70% stenosis with evidence of ischemia (positive stress test, FFR ≤ 0.8, or OCT minimal lumen area (MLA) ≤ 4.0 mm2)\n* Reference vessel diameter: ≥2.5 mm to ≤ 4.0 mm\n* Lesion length: ≥5mm\n* Moderate to severe calcification of the target lesion confirmed by angiography\n* Thrombolysis in Myocardial Infarction (TIMI) flow grade 3 at baseline\n\nExclusion Criteria\n\n* Cardiogenic shock at the time of procedure\n* Primary PCI for ST-segment elevation myocardial infarction (STEMI)\n* Pregnant, nursing, or childbearing potential without adequate contraception\n* Known allergy or contraindication to DAPT (aspirin, clopidogrel, prasugrel, ticagrelor)\n* Planned surgery within 6 months unless DAPT can be maintained\n* Life expectancy \\\u003C12 months due to a serious medical illness (e.g., advanced cancer, end-stage heart failure)\n* Severe kidney dysfunction (CrCl \\\u003C30 mL\u002Fmin) without dialysis\n* Concurrent participation in another investigational study\n* Referral for coronary artery bypass grafting (CABG) after a heart team discussion\n* Angiographic evidence of thrombus at the target lesion\n* Angiographic evidence of significant dissection at the treatment site prior to intervention\n* Lesion with a previously placed stent within 10mm (visual estimate)\n* Last remaining vessel with severely compromised left ventricular function (LVEF \\\u003C30%)\n* Target lesion within a saphenous vein graft (SVG)","ALL","18 Years",{"count":85,"type":86},120,"ESTIMATED","INTERVENTIONAL",[89],"NA","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).",[92,93],"Coronary Artery Disease","Coronary Calcification",[95,96,31,36,97,98],"Coronary calcification","Calcified nodule","Optical coherence tomography","Percutaneous coronary intervention","2026-07-10",{"date":101,"type":102},"2026-07-13","ACTUAL",{"date":104,"type":102},"2025-10-06",{"date":106,"type":86},"2027-12-31",{"name":72,"class":6},1]