[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"coronary-calcification\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:coronary-calcification":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,49,85,114,139,166,178],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"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":20,"type":21},120,"ESTIMATED","INTERVENTIONAL",[24],"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).",[27,28],"Coronary Artery Disease","Coronary Calcification",[30,31,32,33,34,35],"Coronary calcification","Calcified nodule","Intravascular lithotripsy","Rotational atherectomy","Optical coherence tomography","Percutaneous coronary intervention","RECRUITING","2026-07-10",{"date":39,"type":40},"2026-07-13","ACTUAL",{"date":42,"type":40},"2025-10-06",{"date":44,"type":21},"2027-12-31",{"name":46,"class":47},"Annapoorna Kini","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":60,"conditions":61,"keywords":70,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":84},"100572699","orbital-atherectomy-vs-intravascular-lithotripsy-for-the-treatment-of-calcified-coronary-nodules-orbit-shock-100572699","NCT06736665","Orbital Atherectomy vs Intravascular Lithotripsy for the Treatment of Calcified Coronary Nodules (ORBIT-SHOCK).","Comparative Efficacy of Orbital Atherectomy and Intravascular Lithotripsy in the Treatment of Calcified Coronary Nodules. The ORBIT-SHOCK Pilot Study.","ORBIT-SHOCK","Inclusion Criteria:\n\n1. Patients aged ≥ 18 years.\n2. Atherosclerotic coronary artery disease with calcified nodules identified by OCT in a native vessel, eligible for percutaneous coronary revascularization.\n3. Clinical presentation of chronic coronary syndrome or acute coronary syndrome without ST elevation\\*.\n4. Distal vessel reference diameters ≥ 2.5 mm and ≤ 4.0 mm. \\* Non-culprit lesions eligible for revascularization in a staged procedure following a ST-elevation myocardial infarction (STEMI) are considered for inclusion.\n\nExclusion Criteria:\n\n1. Culprit lesions in acute coronary syndrome with ST elevation.\n2. Left main disease.\n3. In-stent restenosis lesions.\n4. Critical stenoses where it is not possible to advance the OCT catheter across the lesion after predilation with a balloon of up to 2 mm in diameter.\n5. Lesion involving a bifurcation with a secondary branch diameter ≥2 mm.\n6. Cardiogenic shock.\n7. Patients requiring cardiac surgery or percutaneous valve intervention within three months before or after angioplasty.\n8. Pregnancy.\n9. Life expectancy of less than one year.\n10. Contraindication for the use of appropriate antiplatelet therapy post-revascularization.\n11. Coronary artery disease with an indication for surgical revascularization.\n12. Advanced chronic kidney disease or anatomical characteristics that contraindicate the use of optical coherence tomography.\n13. Inability to obtain informed consent.\n14. Allergy to eggs or soy, contraindicating the use of OA.",{"count":58,"type":21},50,[24],"The ORBIT-SHOCK pilot study is a multicenter, prospective, randomized clinical trial initiated by investigators. It will include patients diagnosed with atherosclerotic coronary artery disease presenting calcified nodules (CN), identified by optical coherence tomography (OCT), causing significant angiographic stenosis and eligible for revascularization through percutaneous coronary intervention (PCI).\n\nPatients will be randomized in a 1:1 ratio to undergo lesion preparation with either orbital atherectomy (OA) or intravascular lithotripsy (IVL).\n\nThe ORBIT-SHOCK pilot study is a multicenter, prospective, randomized clinical trial initiated by investigators. It will include patients diagnosed with atherosclerotic coronary artery disease presenting calcified nodules (CN), identified by optical coherence tomography (OCT), causing significant angiographic stenosis and eligible for revascularization through percutaneous coronary intervention (PCI). Patients will be randomized in a 1:1 ratio to undergo lesion preparation with either orbital atherectomy (OA) or intravascular lithotripsy (IVL).\n\nThe aim of this pilot trial is to compare PCI outcomes and the incidence of adverse events between both techniques.",[62,28,63,64,65,66,67,68,69],"Coronary Arterial Disease (CAD)","Coronary Calcified Nodules","Orbital Atherectomy","Intravascular Lithotripsy","Optical Coherence Tomography (OCT)","Percutaneous Coronary Intervention (PCI)","Chronic Coronary Syndrome","Acute Coronary Syndrome (ACS)",[71,30,72,73,32,66,67,68,69,55,74],"Coronary arterial disease","Coronary calcified nodules","Orbital atherectomy","ORBIT SHOCK","2026-04-26",{"date":77,"type":40},"2026-04-30",{"date":79,"type":40},"2025-06-12",{"date":81,"type":21},"2027-12",{"name":83,"class":47},"Spanish Society of Cardiology",6,{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":91,"eligibilityCriteria":92,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":93,"targetDuration":4,"studyType":22,"phases":95,"briefSummary":96,"conditions":97,"keywords":100,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":109,"leadSponsor":111,"locationsCount":113},"100632324","aero-cad-study-evaluating-the-shockwave-c2-aero-ivl-system-in-coronary-artery-disease-100632324","NCT07512206","AERO CAD Study Evaluating the Shockwave C2 Aero IVL System in Coronary Artery Disease","AERO CAD: A Prospective, Multi-Center, Single-Arm Study Evaluating the Shockwave C2 Aero Coronary IVL System in Calcified Coronary Artery Disease","AERO CAD","Inclusion Criteria:\n\n1. Age ≥18 years\n2. Patient undergoing percutaneous coronary intervention (PCI) for coronary artery disease\n3. Target lesion(s) intended for treatment with intravascular lithotripsy (IVL) and stent implantation per standard of care\n4. Ability to provide informed consent\n5. Willingness and ability to comply with study follow-up requirements\n\nExclusion Criteria:\n\n1. ST-elevation myocardial infarction (STEMI) at presentation\n2. Cardiogenic shock at time of procedure\n3. In-stent restenosis (ISR) target lesion\n4. Known contraindication to antiplatelet or anticoagulation therapy\n5. Known intolerance or contraindication to contrast media not amenable to premedication\n6. Participation in another investigational drug or device study that could interfere with the endpoints of this study\n7. Life expectancy \\\u003C1 year\n8. Inability or unwillingness to comply with study procedures or follow-up",{"count":94,"type":21},200,[24],"The AERO CAD study is a prospective, multi-center, single-arm, post-market clinical investigation evaluating the procedural performance and clinical outcomes of the Shockwave C2 Aero Coronary Intravascular Lithotripsy (IVL) System in patients with calcified coronary artery disease undergoing percutaneous coronary intervention (PCI).\n\nThe study will enroll up to 200 subjects across up to 8 U.S. sites. The primary objective is to generate real-world evidence on device performance and clinical outcomes, including target lesion failure at 30 days and procedural success.",[98,28,99,63],"Coronary Artery Disease (CAD)","Coronary Calcified Disease",[101,102,103],"Aero CAD","Aero IVL","IVL","NOT_YET_RECRUITING","2026-04-01",{"date":107,"type":40},"2026-04-06",{"date":105,"type":21},{"date":110,"type":21},"2026-12-01",{"name":112,"class":47},"OPCI Core Laboratories LLC",8,{"id":115,"slug":116,"hasResults":11,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":4,"eligibilityCriteria":120,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":121,"targetDuration":4,"studyType":22,"phases":123,"briefSummary":124,"conditions":125,"keywords":126,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":48},"100614247","dcb-vs-des-for-severe-coronary-calcification-after-optimal-modification-assessed-by-qfr-100614247","NCT07277114","DCB vs DES for Severe Coronary Calcification After Optimal Modification Assessed by QFR","Drug Coated Balloons Versus Drug-Eluting Stents for Severe Coronary Calcification After Optimal Calcium Modification Assessed by QFR (PRECISE CAL Study)","Inclusion Criteria:\n\n* Age ≥ 18 years\n\n  * Moderate to severe calcified lesions assessed by coronary angiography\n\n    * In situ coronary artery calcification\n\n      * Target lesion with indications for coronary intervention\n\n        * Target lesion vessel diameter ≥ 2.25 mm and ≤ 4.0 mm\n\n          * Calcification modification treatment performed using rotational atherectomy, intravascular lithotripsy (IVL), or excimer laser coronary angioplasty (ELCA).\n\n            * QFR \\> 0.8 after calcification modification\n\nExclusion Criteria:\n\n* Patients with ST-segment elevation myocardial infarction:\n\n  * Patients with renal failure requiring dialysis or currently undergoing dialysis.\n\n    * Patients whose coronary angiography quality is unsuitable for QFR analysis.\n\n      * Patients with in-stent restenosis.\n\n        ⑤ Patients with other medical conditions and a life expectancy of \\\u003C1 year.\n\n        ⑥ Patients scheduled for surgery within 6 months post-procedure, and whose surgery would interfere with continued use of antiplatelet therapy.\n\n        ⑦ Patients who cannot tolerate dual antiplatelet therapy.\n\n        ⑧ Patients who cannot adhere to the protocol-required follow-up, or whose participation in the trial is deemed risky by the investigator.\n\n        ⑨ Patients who cannot provide written informed consent or cannot follow the trial protocol.\n\n        ⑩ Patients currently participating in another clinical trial for coronary interventional devices.",{"count":122,"type":21},656,[24],"The goal of this clinical trial is to learn if the short and long term effect of drug coated balloon (DCB) is non-inferior to drug eluting stent (DES) in patients with severe coronary calcification after optimal calcium modification assessed by quantitative flow ratio (QFR). The main questions it aims to answer are:\n\n1. Researchers will compare to see if DCB is non-inferior to DES when evaluated by major cardiovascular adverse events (MACE) one year after percutaneous coronary intervention (PCI).\n2. Researchers will compare to see if the perioperative cardiovascular events is different between DCB and DES treated lesions.\n3. Researchers will compare to see if the QFR is different between DCB and DES treated lesions one year after PCI.\n\nParticipants with severe coronary calcification diagnosed by coronary angiography or intravascular ultrasound (IVUS) will receive calcium modification through rotational atherectomy (RA), excimer laser coronary angioplasty (ELCA), or intravascular lithotripsy (IVL). Then, QFR will be measured based on angiographic image. QFR \\>0.8 will be defined as optimal calcium modification and patients will be randomized 1:1 to DCB or DES treated groups. Telephone follow-ups will be conducted at 1 month, 6 months after PCI and .angiophraphy follow-up will be performed at 12 months after PCI.",[28],[127,128,129],"coronary calcification","Drug coated balloon","quantitative flow reserve","2026-02-26",{"date":132,"type":40},"2026-03-02",{"date":134,"type":40},"2026-02-01",{"date":136,"type":21},"2030-12-31",{"name":138,"class":47},"Shanghai Zhongshan Hospital",{"id":140,"slug":141,"hasResults":11,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":4,"eligibilityCriteria":145,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":146,"targetDuration":148,"studyType":149,"phases":4,"briefSummary":150,"conditions":151,"keywords":153,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":4},"100613113","intravascular-imaging-evaluated-calcified-nodule-china-registry-100613113","NCT07262359","Intravascular Imaging Evaluated Calcified Nodule China Registry","A Multi-Center, Prospective, Observational Registry for the Evaluation of Coronary Artery Calcified Nodules Using Intravascular Ultrasound (IVUS) and\u002For Optical Coherence Tomography (OCT) in China (CN-IVI Registry)","Inclusion Criteria:\n\n* The patient must be at least 18 years old.\n\nIntracoronary imaging confirms the presence of at least one calcified nodule lesion.\n\nThe patient is willing and able to comply with the study procedures and follow-up until the study concludes.\n\nThe subject confirms understanding of the study's risks, benefits, and alternative treatments, and has signed the informed consent form approved by the ethics committee prior to any protocol-related procedures.\n\nExclusion Criteria:\n\nContraindication to Procedure: Known contraindication to coronary angiography, PCI, or adjunctive pharmacologic therapy (e.g., aspirin, P2Y12 inhibitors, heparin, contrast media) that cannot be adequately managed with standard medical care.\n\nLife Expectancy: Life expectancy of less than 1 year due to non-cardiac comorbid conditions (e.g., active malignancy, advanced organ failure).\n\nInability to Follow-Up: Inability or unwillingness to comply with the study protocol or scheduled follow-up visits.",{"count":147,"type":21},500,"3 Years","OBSERVATIONAL","What is this study about? This is a nationwide research study in China focused on understanding a specific type of challenging plaque in heart arteries called a Calcified Nodule (CN). The study will use advanced imaging technology inside the blood vessels to see these nodules in great detail, track how they are treated, and see how patients do in the long term.\n\nWhy is this important? Calcified nodules are hard, bony-like plaques that can cause sudden heart attacks. They are difficult to treat with standard procedures like stenting because they are rigid and can be unpredictable. This registry aims to create a large database of real-world cases to help doctors better understand how to identify and manage CNs effectively, ultimately improving patient care and outcomes across China.\n\nWhat are IVUS and OCT? These are sophisticated imaging tools that doctors use during a heart catheterization. Think of them like a \"GPS\" or an \"ultrasound\" for the inside of your arteries.\n\nIVUS (Intravascular Ultrasound): Uses sound waves to create a detailed, 360-degree picture of the artery wall. It shows the size of the plaque and how deep it goes, helping doctors choose the right size stent.\n\nOCT (Optical Coherence Tomography): Uses light waves to create extremely high-resolution images, like a microscope inside the artery. It is excellent for seeing the precise surface and structure of a calcified nodule.\n\nTogether, these tools give doctors a clear view of the problem, which is crucial for planning the best treatment strategy.\n\nWhat will the study do?\n\nThe registry will collect anonymous data from participating hospitals across China. Researchers will analyze:\n\nHow common calcified nodules are in Chinese patients.\n\nThe best ways to use IVUS and OCT to identify and characterize CNs.\n\nWhich treatment techniques (e.g., special balloons, atherectomy) work best.\n\nThe long-term results for patients who receive stents to treat a CN.\n\nWho is this for?\n\nPatients \\& Families: To understand that advanced care and research are being dedicated to complex heart conditions. Participation (if eligible) contributes to medical knowledge that may help future patients.\n\nHealthcare Providers: To provide a standardized, large-scale analysis of CNs, leading to improved diagnosis, treatment guidelines, and procedural techniques for this complex lesion.\n\nThis registry represents a significant step forward in personalized cardiac care in China, using cutting-edge technology to solve a difficult clinical problem.",[27,152,63,28],"Coronary Artery Atherosclerosis",[154,127,155,156,157],"coronary artery disease","coronary calcified nodules","optical coherence tomography","intravascular ultrosound","2025-11-22",{"date":160,"type":40},"2025-12-03",{"date":162,"type":21},"2025-12-01",{"date":164,"type":21},"2031-12-01",{"name":138,"class":47},{"id":167,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":168,"targetDuration":4,"studyType":22,"phases":169,"briefSummary":25,"conditions":170,"keywords":171,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":172,"lastUpdatePostDateStruct":173,"startDateStruct":175,"completionDateStruct":176,"leadSponsor":177,"locationsCount":48},"100592946",{"count":20,"type":21},[24],[27,28],[30,31,32,33,34,35],"2025-10-07",{"date":174,"type":40},"2025-10-09",{"date":42,"type":40},{"date":44,"type":21},{"name":46,"class":47},{"id":179,"slug":180,"hasResults":11,"nctId":181,"briefTitle":182,"officialTitle":183,"acronym":184,"eligibilityCriteria":185,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":186,"targetDuration":187,"studyType":149,"phases":4,"briefSummary":188,"conditions":189,"keywords":192,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":198,"lastUpdatePostDateStruct":199,"startDateStruct":201,"completionDateStruct":203,"leadSponsor":205,"locationsCount":48},"100568236","implementation-of-a-standardized-algorithm-for-coronary-calcification-with-plaque-modification-100568236","NCT06678594","Implementation of a Standardized Algorithm for Coronary Calcification With Plaque Modification","Implementation of a Standardized Algorithm for CoronarY CaLcificatiOn With PlaquE Modification Using UltraSound Guidance to Improve Procedural and Clinical Outcomes (CYCLOPES)","CYCLOPES","Inclusion Criteria:\n\n1. Documented myocardial ischaemia.\n2. At least one moderate to severely calcified native coronary artery lesion confirmed by QCA and\u002For 60MHz HD IVUS, with the presence of significant calcium, ≥70% diameter stenosis by visual estimation (in a reference vessel diameter of ≥2.5mm and ≤4.0mm) and TIMI 3 flow at baseline that is suitable for PCI.\n\n   a. Significant calcium at the target lesion site is defined as either: i. The presence of radiopacities involving both sides of the arterial wall \\>10mm and involving the target lesion on angiography.\n\n   or ii. The presence of \\>270° arc of superficial calcium on HD intravascular imaging with a length \\>5mm or the presence of 360° arc of calcium on HD intravascular imaging. \\[1\\]\n3. It is possible to cross the calcified lesion with a coronary guidewire.\n4. Age ≥ 18 years.\n5. Patient is willing and able to comply with the study procedures and follow-up.\n\nExclusion Criteria:\n\n1. Patients with cardiogenic shock.\n2. ST-segment elevation myocardial infarction.\n3. Instent re-stenosis.\n4. Stent thrombosis.\n5. Coronary artery dissection.\n6. Chronic total occlusion in a major artery.\n7. Left ventricular ejection fraction ≤30%. Need for coronary artery bypass graft surgery.\n\n9\\. Documented allergy to everolimus or to any stent material 10. Any contraindication for dual antiplatelet therapy with aspirin and a P2Y12 inhibitor for at least 3 months (except for patients on oral anticoagulation). 11. For female, pregnancy, breastfeeding or intend to become pregnant within 1 year 12. Life expectancy \\<1 year. 13. Participation in another study with an investigational product. 14. Inability to provide informed consent.",{"count":147,"type":21},"1 Year","In this study, the doctors will follow a set of rules that is called an algorithm. An algorithm is a step-by-step approach that doctors use to guide them when making decisions about the best way to treat their patients. Algorithms are useful because they help doctors decide on the best treatment approach based on the patient's individual circumstances and the best medical evidence available. The algorithm that is being used in this study is called a calcium modification algorithm and it will guide doctors when deciding on the best way to modify or break up the calcium in coronary arteries.\n\nIn this study, we aim to prove that the calcium modification algorithm, described above, safely and effectively guides doctors on the best way to modify calcium in patients' coronary arteries. By doing so, it will help doctors in making decisions about patients' treatment during their procedure. It will also help standardise care for patients, so patients receive the same treatment no matter what hospital they are in or what doctor is treating them.",[190,191,28],"Myocardial Ischaemia","Severely Calcified Coronary Stenoses",[193,127,194,195,196,197],"calcium modification","plaque modification","IVUS","Intravascular Ultrasound","calcium modification algorithm","2024-11-05",{"date":200,"type":40},"2024-11-07",{"date":202,"type":40},"2024-09-24",{"date":204,"type":21},"2027-03-23",{"name":206,"class":47},"Royal College of Surgeons, Ireland"]