[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100053354":3},{"organization":4,"outcomesModule":7,"designInfo":52,"detailedDescription":62,"studyPopulation":51,"armGroups":63,"interventions":84,"overallOfficials":94,"centralContacts":98,"locations":104,"responsibleParty":125,"collaborators":51,"id":129,"slug":130,"hasResults":131,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":135,"eligibilityCriteria":136,"healthyVolunteers":131,"sex":137,"minAge":138,"maxAge":51,"enrollmentInfo":139,"targetDuration":51,"studyType":142,"phases":143,"briefSummary":145,"conditions":146,"keywords":149,"overallStatus":107,"whyStopped":51,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":163},{"fullName":5,"class":6},"Icahn School of Medicine at Mount Sinai","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":51},[9],{"measure":10,"description":11,"timeFrame":12},"Minimum stent area (MSA)","Post-procedural minimum stent area measured at the site of the calcified nodule (Cohort A) or the point of maximum calcification (Cohort B), as assessed by optical coherence tomography (OCT)","Immediately after Index procedure",[14,17,21,25,28,31,34,38,42,45,48],{"measure":15,"description":16,"timeFrame":12},"Number of Calcium fractures","Number and presence of post-IVL calcium fractures identified on OCT",{"measure":18,"description":19,"timeFrame":20},"Target vessel failure (TVF)","Target vessel failure (TVF) defined as composite of cardiac death, target vessel myocardial infarction, and target vessel revascularization","during hospitalization, approximately 1-2 days, 30 days, and 12 months",{"measure":22,"description":23,"timeFrame":24},"Stent thrombosis","Definite or probable stent thrombosis according to academic research consortium-2 (ARC-2) definitions.\n\nDefinite stent thrombosis is defined as the presence of a thrombus within the stent, within 5 mm of the stent edge, or in a side branch of the stented segment, confirmed by angiography or pathology, along with evidence of acute ischemia such as symptoms, ECG changes, or elevated cardiac biomarkers.\n\nProbable is defined as a myocardial infarction in the territory of the stented vessel without angiographic confirmation and without another obvious cause.","12 months",{"measure":26,"description":27,"timeFrame":12},"Device success","Successful lesion crossing and device delivery to the target site",{"measure":29,"description":30,"timeFrame":12},"Angiographic success","Angiographic success defined as stent deployment with residual stenosis \\\u003C30% and TIMI 3 flow without significant angiographic complications (perforation, major dissection, distal embolization, slow flow, or no flow)",{"measure":32,"description":33,"timeFrame":12},"Procedural success","Procedural success defined as angiographic success and no in-hospital TVF",{"measure":35,"description":36,"timeFrame":37},"Bailout or adjunctive calcium modification","Use of additional calcium modification device beyond initial randomized strategy","Intraoperatively during Index procedure",{"measure":39,"description":40,"timeFrame":41},"Pre- and post-dilatation ballon size","Balloon size recorded during lesion preparation and post-dilatation","Immediately before and after Index procedure",{"measure":43,"description":44,"timeFrame":41},"Pre- and post-dilatation inflation pressure","Inflation pressure recorded during lesion preparation and post-dilatation",{"measure":46,"description":47,"timeFrame":37},"Total number of IVL pulses delivered to the lesion during treatment","IVL pulse characteristics - Total number of IVL pulses delivered to the lesion during treatment relative to overall lesion length and calcified segment length",{"measure":49,"description":50,"timeFrame":37},"Lesion length of IVL pulses delivered","IVL pulse characteristics - The lesion length over which pulses were applied, relative to overall lesion length and calcified segment length",null,{"allocation":53,"interventionModel":54,"interventionModelDescription":55,"primaryPurpose":56,"observationalModel":51,"timePerspective":51,"maskingInfo":57},"RANDOMIZED","PARALLEL","Cohort A: RA + IVL vs IVL alone for calcified nodules Cohort B: Operator-determined IVL pulses vs Maximum IVL pulses for non-CN severe calcium","TREATMENT",{"masking":58,"maskingDescription":59,"whoMasked":60},"SINGLE","Participants are blinded to treatment allocation. Operators and investigators are unblinded.",[61],"PARTICIPANT","The trial consists of two cohorts:\n\n* Patients with calcified nodules (CN) (Cohort A)\n* Patients with non-nodular severe coronary calcium (Cohort B)\n\nRandomization will occur as follows:\n\n* Rotational atherectomy followed by intravascular lithotripsy (IVL) or IVL alone for lesion preparation prior to stenting (Cohort A).\n* Operator-determined or maximum IVL pulses prior to stenting. (Cohort B)\n\nThe trial is designed to compare two calcium modification strategies in each cohort with regard to the primary endpoints of post-procedural minimum stent area assessed by optical coherence tomography at the CN site (Cohort A) and at the site of maximum calcification (Cohort B).",[64,71,76,80],{"label":65,"type":66,"description":67,"interventionNames":68},"RA + IVL (Cohort A)","EXPERIMENTAL","Patients with coronary calcified nodules treated with rotational atherectomy followed by intravascular lithotripsy for lesion preparation prior to stenting.",[69,70],"Device: Intravascular lithotripsy","Device: Rotational atherectomy",{"label":72,"type":73,"description":74,"interventionNames":75},"IVL alone (Cohort A)","ACTIVE_COMPARATOR","Patients with coronary calcified nodules treated with intravascular lithotripsy alone for lesion preparation prior to stenting.",[69],{"label":77,"type":66,"description":78,"interventionNames":79},"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.",[69],{"label":81,"type":73,"description":82,"interventionNames":83},"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.",[69],[85,90],{"type":86,"name":87,"description":88,"armGroupLabels":89,"otherNames":51},"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.",[72,77,81,65],{"type":86,"name":91,"description":92,"armGroupLabels":93,"otherNames":51},"Rotational atherectomy","Rotational atherectomy device used to debulk calcified nodules before IVL and stent implantation.",[65],[95],{"name":96,"affiliation":5,"role":97},"Annapoorna S Kini, MD","PRINCIPAL_INVESTIGATOR",[99],{"name":100,"role":101,"phone":102,"phoneExt":51,"email":103},"Keisuke Yasumura, MD","CONTACT","(212) 241-4181","keisuke.yasumura@mountsinai.org",[105],{"facility":106,"status":107,"city":108,"state":108,"zip":109,"country":110,"countryCode":111,"cosmosGeoPoint":112,"geoPoint":117,"contacts":118},"Mount Sinai Hospital","RECRUITING","New York","10029","United States","US",{"type":113,"coordinates":114},"Point",[115,116],-74.00597,40.71427,{"lat":116,"lon":115},[119,121,123],{"name":96,"role":101,"phone":102,"phoneExt":51,"email":120},"annapoorna.kini@mountsinai.org",{"name":100,"role":101,"phone":122,"phoneExt":51,"email":103},"212-241-4181",{"name":124,"role":97,"phone":51,"phoneExt":51,"email":51},"Annapoorna S Kini",{"type":126,"investigatorFullName":127,"investigatorTitle":128,"investigatorAffiliation":5,"oldNameTitle":51,"oldOrganization":51},"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":140,"type":141},120,"ESTIMATED","INTERVENTIONAL",[144],"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).",[147,148],"Coronary Artery Disease","Coronary Calcification",[150,151,87,91,152,153],"Coronary calcification","Calcified nodule","Optical coherence tomography","Percutaneous coronary intervention","2026-07-10",{"date":156,"type":157},"2026-07-13","ACTUAL",{"date":159,"type":157},"2025-10-06",{"date":161,"type":141},"2027-12-31",{"name":127,"class":6},1]