[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"coronary-calcified-nodules\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:coronary-calcified-nodules":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,56,85],{"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":36,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":55},"100572699","orbital-atherectomy-vs-intravascular-lithotripsy-for-the-treatment-of-calcified-coronary-nodules-orbit-shock-100572699",false,"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.","ALL","18 Years",{"count":20,"type":21},50,"ESTIMATED","INTERVENTIONAL",[24],"NA","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.",[27,28,29,30,31,32,33,34,35],"Coronary Arterial Disease (CAD)","Coronary Calcification","Coronary Calcified Nodules","Orbital Atherectomy","Intravascular Lithotripsy","Optical Coherence Tomography (OCT)","Percutaneous Coronary Intervention (PCI)","Chronic Coronary Syndrome","Acute Coronary Syndrome (ACS)",[37,38,39,40,41,32,33,34,35,15,42],"Coronary arterial disease","Coronary calcification","Coronary calcified nodules","Orbital atherectomy","Intravascular lithotripsy","ORBIT SHOCK","RECRUITING","2026-04-26",{"date":46,"type":47},"2026-04-30","ACTUAL",{"date":49,"type":47},"2025-06-12",{"date":51,"type":21},"2027-12",{"name":53,"class":54},"Spanish Society of Cardiology","OTHER",6,{"id":57,"slug":58,"hasResults":11,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":64,"targetDuration":4,"studyType":22,"phases":66,"briefSummary":67,"conditions":68,"keywords":71,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":80,"leadSponsor":82,"locationsCount":84},"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":65,"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.",[69,28,70,29],"Coronary Artery Disease (CAD)","Coronary Calcified Disease",[72,73,74],"Aero CAD","Aero IVL","IVL","NOT_YET_RECRUITING","2026-04-01",{"date":78,"type":47},"2026-04-06",{"date":76,"type":21},{"date":81,"type":21},"2026-12-01",{"name":83,"class":54},"OPCI Core Laboratories LLC",8,{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":4,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":92,"targetDuration":94,"studyType":95,"phases":4,"briefSummary":96,"conditions":97,"keywords":100,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"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":93,"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.",[98,99,29,28],"Coronary Artery Disease","Coronary Artery Atherosclerosis",[101,102,103,104,105],"coronary artery disease","coronary calcification","coronary calcified nodules","optical coherence tomography","intravascular ultrosound","2025-11-22",{"date":108,"type":47},"2025-12-03",{"date":110,"type":21},"2025-12-01",{"date":112,"type":21},"2031-12-01",{"name":114,"class":54},"Shanghai Zhongshan Hospital"]