[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"coronary-artery-calcification\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:coronary-artery-calcification":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,43,76,102,126,151,182,211,227,250,277],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100620305","health-enhanced-artery-risk-tracking-with-widespread-implementation-and-screening-effort-in-ascvd-heartwise-ascvd-100620305",false,"NCT07355894","Health Enhanced Artery Risk Tracking With Widespread Implementation and Screening Effort in ASCVD (HEARTWISE-ASCVD)","Health Enhanced Artery Risk Tracking With Widespread Implementation and Screening Effort in AtheroSclerotic CardioVascular Disease (HEARTWISE-ASCVD) Study","HEARTWISE","Inclusion Criteria:\n\n* Non-gated chest CT performed within the prior 2 years within the health system\n* Active health system engagement with an affiliated clinician eligible for notification, defined as ≥1 clinical visit within the prior 2 years AND at least one of the following:\n\n  1. Active enrollment in the site's integrated healthcare plan (e.g., Kaiser Permanente Northern California), OR\n  2. LDL-C measured within the health system within the prior 2 years, OR\n  3. Outpatient cardiovascular medication prescription within the prior year\n* Meets one of the following clinical criteria:\n\n  1. Clinical ASCVD diagnosis (coronary artery disease, peripheral arterial disease, or ischemic cerebrovascular disease) AND AI-detected CAC \\>0 on non-gated chest CT, OR\n  2. No ASCVD diagnosis AND AI-detected CAC ≥100\n* Suboptimal LDL-C control, defined as either: Last LDL-C ≥70 mg\u002FdL in the last 2 years, OR No LDL-C measurement in the last 2 years\n\nNote: Site-level variations and additional refinements may occur based on local stakeholder input and patient population identification.\n\nExclusion Criteria:\n\n* Dementia\n* Heart transplant\n* Active hospice\n* Other life-limiting illness as determined by the site investigator (e.g., metastatic cancer)\n* Additional participant-level exclusions as determined by clinical stakeholders at each site","ALL","18 Years","74 Years",{"count":21,"type":22},120000,"ESTIMATED","INTERVENTIONAL",[25],"NA","This multi-site study will test whether an opportunistic AI-based CAC screening and notification intervention can improve cholesterol treatment and lower cholesterol levels in adults. The study uses artificial intelligence to detect calcium buildup in heart arteries (coronary artery calcium or CAC) on chest CT scans that patients have already had for other reasons. The study will focus on adults who either have known atherosclerotic cardiovascular disease (ASCVD) or have significant calcium buildup (a CAC score of 100 or higher), and whose cholesterol is not well controlled.\n\nIt will also evaluate how well this approach can be implemented at scale across multiple health systems. The main questions it aims to answer are:\n\nDoes notifying patients and their clinicians about incidental CAC increase lipid-lowering therapy(LLT) initiation or intensification?\n\nDoes the intervention improve Low-Density Lipoprotein(LDL)-cholesterol control and related lipid testing?\n\nHow does the intervention affect downstream care (e.g., clinic visits, cardiology referrals, and cardiac testing)?\n\nResearchers will use an FDA-cleared AI algorithm to quantify CAC on previously performed non-gated chest CT scans and identify eligible participants through the electronic health record. Participants will be randomized to receive CAC notification either right away or after a 6-month delay.",[28,29],"Atherosclerotic Cardiovascular Disease (ASCVD)","Coronary Artery Calcification","NOT_YET_RECRUITING","2026-04-17",{"date":33,"type":34},"2026-04-22","ACTUAL",{"date":36,"type":22},"2026-05",{"date":38,"type":22},"2028-03",{"name":40,"class":41},"Stanford University","OTHER",6,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":23,"phases":52,"briefSummary":53,"conditions":54,"keywords":57,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":75},"100622777","lithotripsy-versus-balloon-angioplasty-for-optimal-treatment-of-calcified-lesions-with-and-without-optical-coherence-tomography-evaluation-100622777","NCT07388030","Lithotripsy Versus Balloon Angioplasty for Optimal Treatment of CAlcified Lesions With and Without Optical Coherence Tomography evaluatION","LOCATION","Inclusion Criteria:\n\n* Clinical Inclusion criteria:\n\n  1. Age ≥18 years;\n  2. Subject presents with:\n\n     1. stable ischemic heart disease or\n     2. acute coronary syndrome (non-ST-segment elevation myocardial infarction \\[NSTEMI\\] or unstable angina), or\n     3. stabilized recent ST-segment elevation myocardial infarction (STEMI) (\\>48 hours prior to enrollment);\n  3. Subject has been fully informed and signed the Institutional Review Board (IRB) approved LOCATION trial Informed Consent Form (ICF) prior to any trial related procedures.\n* Angiographic inclusion criteria：\n\n  1. The reference diameter of each target vessel is ≥2.25 mm and ≤4.0 mm at the lesion site (visual estimation);\n  2. The target lesion(s) have:\n\n  \u003C!-- -->\n\n  1. A stenosis ≥70% and \\\u003C100% (visual estimation), or\n  2. A stenosis of the target lesion ≥50% and \\\u003C70% (visual estimation) with evidence of ischemia via:\n\n     1. Positive stress testing (such as single-photon emission computed tomography, echocardiography, treadmill exercise test, etc.), or computed tomography-fractional flow reserve (CT-FFR) value ≤0.80, or;\n     2. 24-hour Holter electrocardiogram: ST-segment elevation or depression of ≥1 mm in horizontal or down-sloping pattern lasting for at least 1 minute, with an interval of more than 1 minute between two episodes; combined with the patient presenting typical angina symptoms with Canadian Cardiovascular Society grading of angina pectoris II - IV;\n     3. Pressure wire FFR or angioFFR value ≤0.80 or instantaneous wave-free ratio (iFR) value ≤0.89.\n\n        3.The target lesion has fluoroscopic evidence of severe calcium at the lesion site, defined via angiogram as fluoroscopic radiopacities noted without cardiac motion before contrast injection involving both sides of the arterial wall in at least 1 location and total length of calcium of at least 15 mm; All lesions in the non-target vessel, if any, that require treatment are successfully treated without complications prior to randomization, defined as final diameter stenosis ≤20% with final TIMI-3 flow, with no residual dissection grade ≥type B, and no transient or sustained angiographic complications (e.g. distal embolization, side branch closure), no chest pain lasting \\>5 minutes, and no ST-segment elevation or depression lasting \\>5 minutes.\n\n        Exclusion Criteria:\n* Clinical exclusion criteria：\n\n  1. Subject has undergone PCI in the target vessel or its branches within 12 months prior to randomization or prior CABG any time;\n  2. Subject has undergone a PCI procedure in a non-target vessel that is unsuccessful or with complications within 30 days prior to randomization, including during the randomization procedure. Successful and uncomplicated PCI is defined as final diameter stenosis ≤20% with final TIMI-3 flow, no residual dissection grade≥ type B, no transient or sustained angiographic complications (e.g., distal embolization, side branch closure), no chest pain lasting \\>5 minutes, and no ST-segment elevation or depression lasting \\>5 minutes);\n  3. PCI is planned within 12 months post randomization aside from a potential planned staged PCI as part of the randomized treatment strategy;\n  4. Planned use in the randomized lesion(s) of a bare metal stent (BMS), bioresorbable scaffold (BRS), or non-stent treatment only;\n  5. The investigator believes that based on the angiographic appearance that 1) it is unlikely that an OCT catheter can be delivered; 2) if randomized to no IVL, it is unlikely that the lesion(s) can be crossed and pre-dilated by balloon angioplasty alone; 3) if randomized to IVL, it is unlikely that the IVL catheter can be delivered to the lesion (note: pre-dilatation is allowed if necessary for IVL delivery);\n  6. Subject has undergone a prior transcatheter or surgical intervention for a non-coronary cardiac condition (e.g. a TAVR or left atrial appendage occlusion) within the prior 6 months, or is anticipated to need such a procedure within 1 year;\n  7. Subject has severe stenosis or regurgitation of any heart valve, or moderate aortic stenosis or regurgitation;\n  8. Subject has evidence of heart failure by at least one of the following:\n\n  \u003C!-- -->\n\n  1. Left ventricular ejection fraction (LVEF) ≤30% within 1 month prior to enrollment, or\n  2. Current heart failure defined as dyspnea with minimal exertion or at rest (NYHA class III or IV within 1 month of the procedure), or\n  3. Killip class ≥2 for post STEMI patients; 9.Subject is hemodynamically unstable as evidenced by a SBP of \\>160 mmHg or \\\u003C90 mmHg or a heart rate of \\\u003C50 bpm or \\>100 bpm (\\>110 bpm if in atrial fibrillation) 10.Subjects with known allergy to heparin unless bivalirudin will be used as the procedural anticoagulant; 11.Subjects with known allergy to contrast media that cannot be effectively pre-medicated or any prior anaphylaxis to contrast; 12.Subjects with known allergy to aspirin or both clopidogrel and ticagrelor; 13.History of a stroke within 6 months prior to enrollment, excluding transient ischemic attack (TIA) or any prior intracranial bleed; 14.History of active peptic ulcer or upper gastrointestinal bleeding within 6 months prior to enrollment; 15.Inability to tolerate dual antiplatelet therapy for at least 6 months; 16.Known malignancy or any condition with a life expectancy of ≤12 months; 17.Chronic kidney disease (CKD) with an estimated glomerular filtration rate (eGFR) \\\u003C45 mL\u002Fmin\u002F1.73m² or on dialysis; 18.Subject has a history of any cognitive or mental health condition that may interfere with the trial participation including all follow-up visits; 19.Subject is a female who is pregnant (women of child-bearing potential must have a negative pregnancy test within 15 days before the procedure); 20.Subject is participating in or has plans to participate in any other investigational drug or device trial that has not reached its primary endpoint.\n* Angiographic Exclusion Criteria:\n\n  1. There are no lesions in any target vessel (main epicardial coronary artery including its side branches) that requires treatment that do not meet all angiographic inclusion criteria;\n  2. A target lesion is an unprotected LM lesion or an ostial lesion (RCA within 3 mm of the aorta proximal LAD or LCX within 3 mm of the LM);\n  3. A target lesion is a true bifurcation with a severely calcified side branch that requires treatment but cannot be treated with IVL because of its size, angulation or other condition. A severely calcified side branch is defined via angiogram as fluoroscopic radiopacities noted without cardiac motion before contrast injection involving both sides of the arterial wall) Note: If a true bifurcation target lesion is included, the main branch must be severely calcified; the side branch may or may not be severely calcified. However, if the side branch is severely calcified, it must be eligible for IVL treatment. Otherwise, the final treatment for the side branch may be balloon angioplasty, a DCB or a DES as per the judgement of the operator. The main branch must be treated with a DES.\n  4. A target lesion is totally occluded (100% diameter stenosis with TIMI flow ≤1);\n  5. A target lesion contains giant thrombus (defined as angiographic length \\>2x the reference vessel diameter);\n  6. Presence of an aneurysm within 10 mm of the target lesion;\n  7. Angiographic evidence of severe dissection (type D - F defined by NHLBI classification) in the target lesion prior to device treatment;\n  8. A target vessel has severe or excessive tortuosity or is deemed unsuitable for angioplasty by investigator judgement; Any intent to perform intravascular imaging during the randomization procedure (unless randomized to OCT).",{"count":51,"type":22},3060,[25],"Severely calcified coronary artery disease means that calcium has built up in the blood vessels that supply the heart. This makes coronary procedures more difficult and increases the risk of complications during and after treatment.\n\nThe LOCATION Study is a large clinical study designed to compare different commonly used treatment strategies for patients with severely calcified coronary arteries who need a coronary stent. The study aims to find safer and more effective ways to prepare the artery and place the stent in order to improve long-term outcomes.\n\nIn this study, participants will be randomly assigned (like flipping a coin) to one of four treatment groups during their coronary procedure. The treatments differ in two ways: (1) how the calcified artery is prepared before placing the stent, and (2) how imaging is used to guide stent placement.\n\nOne method uses a shockwave-based device to help break calcium in the artery, while the other uses standard balloon treatment. For imaging guidance, one approach uses a high-resolution imaging catheter inside the artery, and the other relies on standard X-ray imaging. All participants will receive a standard, approved drug-eluting stent as part of routine care.\n\nThe main goal of the study is to determine which treatment approach best reduces serious heart-related problems over three years. These problems include heart-related death, heart attack in the treated vessel, or the need for another procedure on the same vessel.\n\nAdults aged 18 years or older with significant coronary artery narrowing and severe calcium buildup may be eligible to participate. All participants must provide written informed consent before joining the study.\n\nParticipants will be followed during their hospital stay and through regular follow-up visits or phone calls for up to three years after the procedure. Information collected during the study will help doctors better understand how to treat patients with severely calcified coronary arteries in the future.\n\nParticipation in this study is voluntary, and patients may withdraw at any time without affecting their medical care. All study devices used in this trial are approved for clinical use, and patient privacy will be protected according to applicable regulations.",[55,56,29],"Coronary Artery Disease","Severe Coronary Artery Disease",[58,59,60,61,62,63,64],"severe coronary calcified lesions","intravascular lithotripsy (IVL)","balloon angioplasty (BA)","optical coherence tomography (OCT)-guided","angiography-guided","target vessel failure (TVF)","percutaneous coronary intervention (PCI)","2026-03-10",{"date":67,"type":34},"2026-03-12",{"date":69,"type":22},"2026-03-20",{"date":71,"type":22},"2030-06-30",{"name":73,"class":74},"Shanghai Bluesail Boyuan Medical Technology Co., Ltd.","INDUSTRY",1,{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":83,"targetDuration":85,"studyType":86,"phases":4,"briefSummary":87,"conditions":88,"keywords":89,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":75},"100627108","intravascular-imaging-guided-intravascular-lithotripsy-for-severe-coronary-calcified-lesions-100627108","NCT07444346","Intravascular Imaging-Guided Intravascular Lithotripsy for Severe Coronary Calcified Lesions.","Intravascular Imaging-Guided Intravascular Lithotripsy for Severe Coronary Calcified Lesions, a Prospective,Observational, Single-center Registry Study.","Inclusion Criteria:\n\n1. Patients with coronary angiography showing vessel diameter stenosis ≥ 70% and moderate to severe calcification;\n2. Reference vessel diameter ≥ 2.5 mm;\n3. Signed informed consent form.\n\nExclusion Criteria:\n\n1. Patients with comorbid conditions such as malignant tumors and an expected lifespan of less than 1 year;\n2. Patients with hemodynamic instability;\n3. Patients classified as New York Heart Association (NYHA) functional class IV;\n4. Any other conditions deemed by the investigator as unsuitable for enrollment.",{"count":84,"type":22},200,"6 Months","OBSERVATIONAL","This study aims to investigate the efficacy and safety of intravascular lithotripsy (IVL) balloon in treating coronary calcified lesions at our center.",[29,55],[90,91,92],"intravascular lithotripsy","coronary artery calcification","percutaneous coronary intervention","2026-02-26",{"date":95,"type":34},"2026-03-02",{"date":97,"type":22},"2026-02-10",{"date":99,"type":22},"2027-01-30",{"name":101,"class":41},"The First Affiliated Hospital with Nanjing Medical University",{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":4,"eligibilityCriteria":108,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":109,"enrollmentInfo":110,"targetDuration":4,"studyType":86,"phases":4,"briefSummary":112,"conditions":113,"keywords":114,"overallStatus":118,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":75},"100623728","a-novel-ferumoxytol-enhanced-cardiac-magnetic-resonance-for-the-detection-of-calcified-coronary-arteries-100623728","NCT07400406","A Novel Ferumoxytol-enhanced Cardiac Magnetic Resonance for the Detection of Calcified Coronary Arteries","Diagnostic Performance of a Novel Ferumoxytol-enhanced Cardiac Magnetic Resonance for the Detection of Calcified Coronary Arteries: A Single-center Clinical Study.","Inclusion Criteria:\n\n1. Age ≥18 years, \\\u003C75 years;\n2. Imaging specialists evaluate CCTA images taken within 30 days and report that calcification occupied one or more of the patient's vascular lumen at an angle of \\>50% (using the coronary artery segmentation method recommended by the American Heart Association, including nine segments of the major branches of the coronary artery);\n3. Patient who will undergo coronary angiography;\n4. Patient with normal renal function or chronic renal insufficiency (CKD) stage 1-3;\n5. Patient who signs the informed consent.\n\nExclusion Criteria:\n\n1. People who are allergic to iodine contrast media or have a history of allergy to iron or dextran or are allergic themselves;\n2. Because of psychological (such as suffering from claustrophobic syndrome) or physical reasons (such as the presence of metal objects in the body) can not receive MRI examination;\n3. suffering from terminal diseases (such as malignant tumors) or life expectancy \\\u003C 1 year;\n4. Pregnant or lactating women;\n5. People with limited hearing;\n6. Patients with grade III-IV heart function;\n7. Patients with a history of coronary artery stent implantation or coronary artery bypass;\n8. Other iron agents are being used orally or intravenously;\n9. Patients with hemosiderosis or hemochromatosis;\n10. Patients with acute coronary syndrome;\n11. Patients with hyperthyroidism;\n12. Any other candidates deemed unsuitable by the researchers.","75 Years",{"count":111,"type":22},100,"This study is a single-center, prospective, controlled, diagnostic study. The study will be consecutive and is expected to enroll 100 patients with CCTA confirmed coronary calcified lesions. The purpose of this study was to compare the accuracy of novel Ferumoxytol-enhanced Cardiac Magnetic Resonance (Fe-CMR) and coronary CT angiography (CCTA) in detecting calcified coronary arteries, using coronary angiography (CAG) and optical coherence imaging (OCT) as gold standards.",[29],[115,116,117,29],"Ferumoxytol","Magnetic Resonance Imaging","Ultrasmall Superparamagnetic Iron Oxide Particles","RECRUITING","2026-02-02",{"date":97,"type":34},{"date":122,"type":34},"2024-01-26",{"date":124,"type":22},"2027-08-31",{"name":101,"class":41},{"id":127,"slug":128,"hasResults":11,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":132,"eligibilityCriteria":133,"healthyVolunteers":11,"sex":17,"minAge":134,"maxAge":4,"enrollmentInfo":135,"targetDuration":4,"studyType":23,"phases":137,"briefSummary":139,"conditions":140,"keywords":4,"overallStatus":118,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":149,"locationsCount":75},"100504218","phase-4-high-intensity-statin-and-ezetimibe-therapy-for-asymptomatic-patients-with-positive-coronary-calcium-100504218","NCT05845424","High-intensity Statin and Ezetimibe Therapy for Asymptomatic Patients With Positive Coronary Calcium","Comparison of Efficacy and Safety of High-Intensity Statin and Ezetimibe Combination Versus StanDard carE in AsymptomatiC PatIentS wIth Presence of COroNary Artery CALCIUM (DECISION-CAL)","DECISION-CAL","Inclusion Criteria:\n\n* Subject must be at least 40 years of age.\n* Asymptomatic patients with presence of coronary calcification (Agatston Score ≥ 100)\n* low-density lipoproteins cholesterol (LDL-C) \\\u003C190 mg\u002FdL\n\nExclusion Criteria:\n\n* Objective evidence of at least moderate inducible ischemia requiring revascularization treatment\n* History of cerebrovascular disease\n* History of coronary or peripheral arterial revascularization\n* Active liver disease or persistent unexplained serum transaminase elevations more than 2 times the upper limit of normal range\n* History of any adverse drug reaction requiring discontinuation of statin (e, g. rhabdomyolysis)\n* Allergy or sensitivity to any statin or ezetimibe\n* Concurrent treatment with cyclosporine or a condition likely to result in organ transplantation and the need for cyclosporine\n* Pregnancy or breast feeding\n* Non-cardiac co-morbid conditions are present with life expectancy \\\u003C1 year or that may result in protocol non-compliance (per site investigator's medical judgment)\n* Unwillingness or inability to comply with the procedures described in this protocol.","40 Years",{"count":136,"type":22},6000,[138],"PHASE4","The aim of this study is to compare safety and efficacy between the aggressive treatment with combination of high-intensity statin and ezetimibe and the current standard lipid lowering treatment in asymptomatic patients with presence of coronary calcification.",[29,141,142],"Metabolic Syndrome","Dyslipidemias","2025-01-12",{"date":145,"type":34},"2025-01-14",{"date":147,"type":34},"2023-07-03",{"date":71,"type":22},{"name":150,"class":41},"Samsung Medical Center",{"id":152,"slug":153,"hasResults":11,"nctId":154,"briefTitle":155,"officialTitle":156,"acronym":157,"eligibilityCriteria":158,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":159,"enrollmentInfo":160,"targetDuration":162,"studyType":86,"phases":4,"briefSummary":163,"conditions":164,"keywords":171,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":174,"startDateStruct":176,"completionDateStruct":178,"leadSponsor":180,"locationsCount":4},"100559566","a-maajor-radiation-based-pci-study-in-stemi-and-nstemi-100559566","NCT06565793","A MAajor RAdiation-based PCI Study in STEMI and NSTEMI","The Impact of Radiation Delivered to the Patient and the Amount of Iodinated Contrast Medium Injected in Complex Versus Noncomplex Percutaneous Coronary Intervention.","MARAA","Inclusion Criteria:\n\n* The patient presents with a STEMI or NSTEMI requiring either a non-complex or complex PCI.\n\nExclusion Criteria:\n\n\\-","90 Years",{"count":161,"type":22},15630,"5 Years","In France and Italy, approximately 240,000 percutaneous coronary angioplasties (PCI) are performed annually, with an increasing number of complex procedures, including those involving the left coronary common trunk, a bifurcation, chronic occlusion, or requiring Rotablator Rotary Atherectomy (ARota). The medical literature lacks sufficient data regarding several key aspects of complex angioplasty. These include the epidemiological characteristics of patients undergoing such procedures, the impact of irradiation delivered and the quantity of iodine injected on these lengthy procedures, their procedural complication rate, and in-hospital mortality.",[165,166,167,168,29,169,170,55],"Myocardial Infarction (MI)","Radiation Toxicity","Coronary Stenosis","Coronary Thrombosis","Coronary Occlusion","Coronary Syndrome",[172],"PCI,DES, Radiation","2024-12-21",{"date":175,"type":34},"2024-12-27",{"date":177,"type":22},"2025-03-01",{"date":179,"type":22},"2025-12-31",{"name":181,"class":41},"Centre Cardiologique du Nord",{"id":183,"slug":184,"hasResults":11,"nctId":185,"briefTitle":186,"officialTitle":186,"acronym":187,"eligibilityCriteria":188,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":189,"targetDuration":191,"studyType":86,"phases":4,"briefSummary":192,"conditions":193,"keywords":4,"overallStatus":118,"whyStopped":4,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":203,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":209,"locationsCount":75},"100521900","complex-registry---a-prospective-cohort-study-to-describe-the-management-and-outcomes-of-patients-presenting-with-complex-and-calcified-coronary-artery-disease-100521900","NCT06075602","COMPLEX Registry - a Prospective COhort Study to Describe the Management and Outcomes of Patients Presenting with CompLEX and Calcified Coronary Artery Disease","COMPLEX","Inclusion Criteria:\n\n* Subject \\>18 years of age\n* Individuals presenting with chronic, complex and\u002For calcified CAD and requiring PCI or CABG\n* Complex coronary artery disease \u002F lesions must include at least one of the following attributes:\n* Long and\u002F or heavily calcified coronary lesions\n* In-stent restenosis\n* Chronic total occlusions (CTO)\n* Left main lesions\n* Bifurcation lesions\n* Bypass graft lesions\n* Small vessel disease \u002F coronary microvascular dysfunction (e.g. not amenable to PCI)\n* Subjects must be willing to sign a patient informed consent (PIC) or must have signed the General Consent (GK).\n\nExclusion Criteria:\n\nThe presence of any one of the following exclusion criteria will lead to exclusion of the patient.\n\n* Patient is \\\u003C18 years of age\n* Patient unwilling or unable to provide informed consent\n* Patients with no complex and calcified CAD",{"count":190,"type":22},5000,"10 Years","The purpose of the COMPLEX Registry is to prospectively and retrospectively collect baseline, clinical and procedural data of patients who have undergone PCI or CABG for complex and\u002F or calcified chronic CAD, irrespective of clinical presentation as well as to prospectively collect data about their clinical outcomes. The outcomes will be compared in different clinical subgroups (e.g. PCI vs. CABG). The impact of current PCI techniques\u002F devices, but also CABG strategies in different clinical settings and coronary artery lesions on cardiovascular outcomes will be assessed.",[194,55,195,196,29,197,198,199,200,201],"Coronary Disease","Coronary Restenosis","Coronary Arteriosclerosis","Stable Chronic Angina","Angina Pectoris","Angina, Stable","Angina, Unstable","Stent Thrombosis","2024-10-27",{"date":204,"type":34},"2024-10-29",{"date":206,"type":34},"2021-11-01",{"date":208,"type":22},"2031-12-31",{"name":210,"class":41},"Luzerner Kantonsspital",{"id":212,"slug":213,"hasResults":11,"nctId":214,"briefTitle":215,"officialTitle":215,"acronym":216,"eligibilityCriteria":217,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":218,"targetDuration":191,"studyType":86,"phases":4,"briefSummary":220,"conditions":221,"keywords":4,"overallStatus":118,"whyStopped":4,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":222,"startDateStruct":223,"completionDateStruct":225,"leadSponsor":226,"locationsCount":75},"100438392","siroop-registry---a-prospective-registry-study-to-evaluate-the-outcomes-of-coronary-artery-disease-patients-treated-with-sirolimus-or-paclitaxel-eluting-balloon-catheters-100438392","NCT04988685","SIROOP Registry - A Prospective Registry Study to Evaluate the Outcomes of Coronary Artery Disease Patients Treated With SIROlimus Or Paclitaxel Eluting Balloon Catheters","SIROOP","Inclusion Criteria:\n\n* Subject \\>18 years of age\n* Patients with significant acute or chronic coronary de-novo lesions or ISR lesions requiring treatment using PCI\n* Treatment with at least one DCB (device choice at the operator's discretion) In case of a patient with lesions treated at different procedural time, lesions will be separately collected and documented\n* Subjects must be willing to sign a patient informed consent (PIC) or must have signed the General Consent (GK).\n\nExclusion Criteria:\n\n* Patient is \\\u003C18 years of age\n* Patient unwilling or unable to provide informed consent\n* pregnancy and lactation\n* Indication for surgical revascularization",{"count":219,"type":22},2000,"The purpose of the SIROOP Registry is to retrospectively and prospectively collect baseline, clinical and procedural characteristics of patients who have undergone PCI and are treated with either currently available sirolimus or paclitaxel coated DCBs (see Table 1), irrespective of clinical presentation as well as to prospectively collect data about their clinical outcomes. Outcomes will be compared in different clinical subgroups. The impact of current DCBs in different clinical settings and coronary artery lesions on cardiovascular outcomes will be assessed.",[194,55,195,196,29,197,198,199,200,201],{"date":204,"type":34},{"date":224,"type":34},"2021-06-01",{"date":208,"type":22},{"name":210,"class":41},{"id":228,"slug":229,"hasResults":11,"nctId":230,"briefTitle":231,"officialTitle":232,"acronym":233,"eligibilityCriteria":234,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":235,"targetDuration":4,"studyType":23,"phases":237,"briefSummary":238,"conditions":239,"keywords":4,"overallStatus":118,"whyStopped":4,"lastUpdateSubmitDate":242,"lastUpdatePostDateStruct":243,"startDateStruct":245,"completionDateStruct":247,"leadSponsor":249,"locationsCount":75},"100465849","the-value-of-ivl-compared-to-opn-non-compliant-balloons-for-treatment-of-refractory-coronary-lesions-victory-trial-100465849","NCT05346068","The Value of IVL Compared To OPN Non-Compliant Balloons for Treatment of RefractorY Coronary Lesions (VICTORY) Trial","The Value of IVL Compared To OPN Non-Compliant Balloons for Treatment of RefractorY Coronary Lesions (VICTORY) Trial - A Randomized, Multicenter, Non-inferiority Comparison of Shockwave Intravascular Lithotripsy (IVL) and the OPN Non-compliant Balloon for Treatment of Calcified and Refractory Coronary Lesions","VICTORY","Clinical inclusion criteria:\n\n* Age ≥18 years and consentable;\n* Acute or chronic coronary artery disease with ischemia related symptoms (e.g. angina) and\u002For evidence of myocardial ischemia (e.g. FFR\u002F iFR, CMR, SPECT or PET-CT);\n* Angiographically-proven coronary artery disease;\n* Lesions in non-target vessels requiring PCI may be treated either\n\n  * prior to the study procedure if the procedure was unsuccessful or complicated; or\n  * in the same session if feasible and safe for the patient, otherwise a staged PCI procedure for non-target vessels may be considered;\n* Informed Consent signed by the subject.\n\nAngiographic inclusion criteria:\n\n* Single de novo target lesion stenosis of protected LMCA, or LAD, RCA or LCX (or of their branches) with\\*:\n\n  * Stenosis of ≥70%;\n  * Stenosis ≥50% and \\\u003C70% (visually assessed) with evidence of ischemia via positive stress test, or fractional flow reserve value ≤0.80, or iFR \\\u003C0.90 or IVUS minimum lumen area ≤4.0 mm²;\n* The target vessel reference diameter must be ≥2.5 mm \\& ≤4.5mm;\n* AND AT LEAST ONE OF THE FOLLOWING CRITERIA:\n\n  * Evidence of calcification at the lesion site by angiography (Grade 3), with fluoroscopic radio-opacities noted without cardiac motion prior to contrast injection involving both sides of the arterial wall in at least one location and total length of calcium of at least 15 mm and extending partially into the target lesion,\n  * AND\u002F OR by OCT, with presence of ≥270° calcium;\n  * AND\u002F OR Prior attempt at PCI with inability to expand a balloon in target lesion.\n\nAnnotation: Only one lesion and vessel per randomized patient may be treated according to protocol and considered for the purpose of this study. The lesion considered for the study should represent the most calcified one.\n\nThe presence of any one of the following exclusion criteria will lead to the exclusion of the subject:\n\nExclusion criteria:\n\n* Patient experienced an acute STEMI or cardiogenic shock related to an acute MI within 2 days prior to index procedure;\n* Any comorbidity or condition which may reduce compliance with this protocol, including follow-up calls\u002F visits (e.g. advanced dementia);\n* Any medical, geographic, and\u002For social factor making study participation impractical or precluding required follow-up.\n* Patient is pregnant or nursing (a negative pregnancy test is required for women of child-bearing potential within 7 days prior to enrollment);\n* Unable to take a P2Y12 inhibitor (i.e. clopidogrel, prasugrel, or ticagrelor) for at least 6 months;\n* Patient has an allergy to imaging contrast media which cannot be adequately pre-medicated;\n* Renal failure with an eGFR \\\u003C30ml\u002Fmin1.73m2;\n* History of a stroke or transient ischemic attack (TIA) within 7 days, or any prior intracranial hemorrhage;\n* Active peptic ulcer or upper gastrointestinal (GI) bleeding within 6 months;\n* Untreated pre-procedural hemoglobin \\\u003C10g\u002FdL or intention to refuse blood transfusions if one should become necessary;\n* Patient has an allergy or intolerance to cobalt-chromium and\u002F or everolimus.\n* Life expectancy of less than 1 year.\n\nAngiographic exclusion criteria:\n\n* Anatomy where the device or OCT catheter are unlikely to be delivered due to tortuosity or other characteristics;\n* Target lesion is in a coronary artery bypass graft;\n* Target lesion is an in-stent restenosis (ISR);\n* Flow limiting target vessel thrombus (evident on angiography or OCT);\n* Definite or possible thrombus (by angiography or intravascular imaging) in the target vessel;\n* Evidence of aneurysm in target vessel within 10 mm of the target lesion.\n\nOf note, only qualified physicians who are investigators or a sub-investigators for the trial will assess each individual´s eligibility criteria and take the final decision to include the subject in the trial (ICH GCP 4.3.1). This decision will be documented prior to the subject receiving the first intervention.",{"count":236,"type":22},280,[25],"Percutaneous coronary intervention (PCI) with drug-eluting stent (DES) implantation has become the dominant treatment strategy for patients with acute and chronic coronary artery disease (CAD) requiring revascularization. Nonetheless, PCI with stent implantation has some limitations and especially patients with severely calcified coronary lesions (approximately 10-20% of all patients with CAD) have an elevated risk for adverse outcomes, including target lesion failure (TLF) and stent thrombosis (ST).\n\nSeveral dedicated PCI devices have been developed for treatment of severely calcified lesions. Whereas especially two of them have shown promising results in smaller, prospective studies. First, the super high-pressure NC PCI balloon (OPN™ NC, SIS Medical AG, Frauenfeld, Switzerland) has been shown to represent an effective and safe device for lesion preparation. Second, the lately introduced Shockwave intravascular lithotripsy (IVL)™ balloon catheter (Shockwave Medical, Santa Clara, CA, USA) appears to be a safe and efficient alternative device for treatment of calcified coronary lesions. However, it remains unknown, if the OPN™ NC balloon is non-inferior to to IVL regarding lesion preparation and completeness of stent expansion in severely calcified lesions.",[194,55,240,241,29],"Calcific Coronary Arteriosclerosis","Stent Restenosis","2024-06-16",{"date":244,"type":34},"2024-06-18",{"date":246,"type":34},"2022-11-22",{"date":248,"type":22},"2028-05-30",{"name":210,"class":41},{"id":251,"slug":252,"hasResults":11,"nctId":253,"briefTitle":254,"officialTitle":255,"acronym":4,"eligibilityCriteria":256,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":257,"targetDuration":4,"studyType":86,"phases":4,"briefSummary":259,"conditions":260,"keywords":266,"overallStatus":118,"whyStopped":4,"lastUpdateSubmitDate":269,"lastUpdatePostDateStruct":270,"startDateStruct":272,"completionDateStruct":273,"leadSponsor":275,"locationsCount":75},"100430743","coronary-artery-calcification-in-type-2-diabetes-mellitus-uscac-study-100430743","NCT04889053","Coronary Artery Calcification in Type 2 Diabetes Mellitus (USCAC Study)","Prospective Cohort Study of Coronary Artery Calcification in Type 2 Diabetes Mellitus (USCAC Study)","Inclusion Criteria:\n\n* Age ≥ 18 years old\n* Type 2 diabetes is diagnosed according to WHO diagnostic criteria\n* Low dose prospectively triggered sequential dual-source CT coronary angiography can be performed at baseline investigation\n* Those subjects are able to understand the purpose and procedure of this study and sign the informed consent voluntarily\n\nExclusion Criteria:\n\n* Those have received coronary artery stenting or coronary artery bypass grafting\n* Those with severe lung (respiratory failure), liver (ALT or AST 3 times normal value or bilirubin increase), renal dysfunction\\[GFR \\\u003C 45ml\u002F(min.1.73m2) or dialysis patients\n* Malignant tumor\n* Mental illness or mental retardation\n* Pregnant or lactating women or those with fertility planning\n* Concomitant diseases (hyperparathyroidism, sarcoidosis, amyloidosis) affecting calcium balance and soft tissue calcification\n* Contraindications of contrast agents\n* Based on the judgment of the researcher, the compliance is poor and the study could not be completed according to the requirements",{"count":258,"type":22},1400,"Coronary artery calcification (CAC) is a common complication of type 2 diabetes mellitus(T2DM), which can significantly increase all-cause mortality and the incidence of serious cardiovascular events, and increase the burden of the national economy. The epidemiological characteristics and the clinical progress of CAC are still not clear. Moreover, the pathogenesis of CAC has not yet been fully elucidated, and lack of specific diagnostic indicators. Arterial calcification is an active, reversible, and multifactorial biological process like bone formation. It is generally believed that early detection of calcification lesions and active targeted treatment may be the key to prevention and treatment of vascular calcification. In addition, statins are commonly used in patients with dyslipidemia and can stabilize CAC plaque. However, the timing, dosage and effect of statins are controversial. Moreover, our previous study found that the expression of miR-32 is significantly elevated in patients with CAC, and can promoting vascular calcification. Herein, this study is to conduct a prospective cohort study on T2DM patients with CAC in Hunan province through a multidisciplinary and multi-center cooperation model, the main research objectives include the following three parts: ① To identify the prevalence, incidence, and characteristics of CAC in T2DM patients in Hunan province, and to build a risk assessment model. ② To observe the effects of statins on the occurrence and development of CAC in patients with T2DM, and to provide clinical data for the improvement of medication guidelines; ③To observe the dynamic changes of serum miR-32 in the progression of CAC in patients with T2DM, and to explore its possibility as a serological diagnosis or prognostic bio-maker of CAC. The completion of this research project is expected to bring a new breakthrough in the field of early diagnosis, prognosis evaluation, and intervention treatment of patients with T2DM combined with CAC, and provide an important reference for the formulation of cardiovascular disease prevention and control strategy.",[261,262,29,263,264,265],"Type 2 Diabetes","Vascular Calcification","Strains","Epidemiology","microRNA",[261,267,264,268],"Vascular calcification","microRNA-32","2021-09-27",{"date":271,"type":34},"2021-09-29",{"date":224,"type":34},{"date":274,"type":22},"2030-12-31",{"name":276,"class":41},"University of South China",{"id":278,"slug":279,"hasResults":11,"nctId":280,"briefTitle":281,"officialTitle":281,"acronym":282,"eligibilityCriteria":283,"healthyVolunteers":11,"sex":17,"minAge":284,"maxAge":4,"enrollmentInfo":285,"targetDuration":287,"studyType":86,"phases":4,"briefSummary":288,"conditions":289,"keywords":290,"overallStatus":118,"whyStopped":4,"lastUpdateSubmitDate":294,"lastUpdatePostDateStruct":295,"startDateStruct":297,"completionDateStruct":299,"leadSponsor":301,"locationsCount":303},"100419496","rovus-asia-registry-evaluate-safety-and-effectiveness-of-rotational-atherectomy-and-intravascular-ultrasound-for-heavily-calcified-coronary-lesion-100419496","NCT04742478","ROVUS Asia Registry (Evaluate Safety and Effectiveness of Rotational Atherectomy and Intravascular Ultrasound for Heavily Calcified Coronary Lesion)","ROVUS","Inclusion Criteria:\n\n* Able to understand and sign an informed consent form\n* Presence of clinical indication for percutaneous coronary intervention (PCI) and\u002For stent placement\n* Subjects willing to comply with all research and follow-up requirements.\n* Angiographic criteria (ONE of the following criteria MUST be met)\n\n  1. Target lesions visually have at least moderate calcifications\\*\n  2. Target lesion balloon dilatation failure\n  3. Inability of devices (microcatheters, balloons or stents) to pass through the target lesion.\n* Procedural criteria\n\n  1. All patients treated with RA with or without other forms of debulking therapy\n\n     * Moderate calcification is defined as radio-opacities noted only during cardiac cycle prior to contrast injection whereas severe calcification is defined as radio-opacities seen without cardiac motion prior to contrast injection, usually affecting both sides of the arterial lumen.\n\nExclusion Criteria:\n\n* Decline to give consent","21 Years",{"count":286,"type":22},1000,"1 Year","Rotablation with or without other calcium debulking therapies is a safe adjunctive procedure for patients with severe coronary calcification requiring Percutaneous Coronary Intervention (PCI).",[29],[291,292,293],"Atherosclerotic Calcification","Medial Artery Calcification","Rotational Atherectomy","2021-04-21",{"date":296,"type":34},"2021-04-23",{"date":298,"type":34},"2021-03-10",{"date":300,"type":22},"2026-12-31",{"name":302,"class":41},"National Heart Centre Singapore",2]