[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"atherosclerosis-of-coronary-artery\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:atherosclerosis-of-coronary-artery":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,52,77],{"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":34,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100599991","safety-and-clinical-performance-of-the-freesolve-resorbable-magnesium-scaffold-system-in-the-treatment-of-subjects-with-long-de-novo-lesions-100599991",false,"NCT07091682","Safety and Clinical Performance of the Freesolve Resorbable Magnesium Scaffold System in the Treatment of Subjects With Long de Novo Lesions","BIOTRONIK - Safety and Clinical Performance of the Drug Eluting Resorbable MAGnesium Scaffold (Freesolve) in the Treatment of Subjects With Long de Novo Lesions in Native Coronary Arteries: BIOMAG-LL","BIOMAG-LL","Inclusion Criteria:\n\nClinical Inclusion Criteria\n\n1. Subject is ≥ 18 years and ≤ 80 years of age\n2. Subject has provided written informed consent as approved by the Independent Ethical Committee (IEC) or Institutional Review Board (IRB) of the respective clinical site prior to the study related procedures\n3. Subject is eligible for PCI according to the applicable guidelines\n4. Subject is an acceptable candidate for coronary artery bypass surgery\n5. Subjects with stable or unstable angina pectoris, documented silent ischemia\u002Fabnormal physiologic testing or hemodynamically stable non-ST elevation myocardial infarction (NSTEMI) patients without angiographic evidence of thrombus at target lesion\n\n   Note: STEMI patients may be eligible for the study for treatment of selected non-culprit lesions, if:\n   * Subject and target lesion(s) meet all inclusion and no exclusion criteria and consent occurs at least ≥ 72 hours after successful treatment of the culprit lesion(s) \\[lesion(s) causing the acute STEMI\\];\n   * Subject is hemodynamically stable with documented declining cardiac biomarkers;\n   * Target lesion(s) to be treated are not located in the culprit vessel(s) and are not culprit lesion(s)\n6. Subject is eligible for Dual Antiplatelet Therapy (DAPT) with aspirin plus either clopidogrel, prasugrel, ticagrelor, cangrelor or ticlopidine\n7. Documented left ventricular ejection fraction (LVEF) ≥ 30% within 6 months prior to or during the procedure (prior to enrollment)\n8. Subject is willing and able to comply with protocol requirements, including completion of study visits for the duration of the study\n\nAngiographic Inclusion Criteria\n\n1. Subjects with a maximum of two single de novo target lesions each in separate native coronary arteries\n2. Target vessel must have a reference diameter between 2.7-4.2 mm by visual estimation, which may be assisted by Quantitative Coronary Angiography (QCA) \u002F Intravascular Ultrasound (IVUS) \u002F Optical Coherence Tomography (OCT)\n3. Target lesion must be \\>28 mm and ≤ 38 mm in length by operator visual estimation, which may be assisted by QCA \u002F IVUS \u002F OCT, and should be amenable to treatment with a single study device\n4. Target lesion stenosis ≥ 50% and \\\u003C 100% by operator visual estimation, which may be assisted by QCA \u002F IVUS \u002F OCT. Target lesion stenosis \\\u003C 70% by visual estimation, should have clinical justification for treatment as per local standards.\n5. Target lesion must have a Thrombolysis In Myocardial Infarction (TIMI) flow ≥1\n\nExclusion Criteria:\n\nClinical Exclusion Criteria\n\n1. Subject is pregnant and\u002For breastfeeding or intends to become pregnant during the duration of the study\n2. Subject has clinical symptoms and\u002For electrocardiogram (ECG) changes consistent with STEMI \\\u003C 72 hours prior to the index procedure.\n\n   Note: Hemodynamically stable non-STEMI (NSTEMI) subjects are eligible for study enrollment.\n3. Subject has undergone prior PCI within the target vessel during the last 12 months prior to the index procedure or prior PCI within a non-target vessel \\\u003C72 hours prior to the index procedure (time window is defined as the time from the end of previous intervention to the start of index procedure)\n4. Subject is on dialysis or with impaired renal function (serum creatinine \\> 2.5 mg\u002FdL or 221 µmol\u002FL, determined within 72 hours prior to the index procedure)\n5. Subject has a known allergy to contrast medium that cannot be adequately premedicated, or any known allergy to aspirin, P2Y12 inhibitors, both heparin and bivalirudin, sirolimus (or similar limus drugs), poly L-lactide, the scaffold material (magnesium, aluminum, tantalum)\n6. Subject is receiving oral or intravenous immunosuppressive therapy (inhaled steroids are permitted) or has known life-limiting immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematosus; diabetes mellitus is permitted)\n7. Life expectancy less than 1 year\n8. Planned surgery or dental surgical procedure within 6 months after index procedure, unless DAPT can be maintained.\n9. In the investigator's opinion subject will not be able to comply with the follow-up requirements\n10. Subjects under oral anticoagulation therapy (OAC) prior to index procedure unless DAPT + OAC (i.e. triple therapy) can be maintained for a minimum of 1 month\n11. Subject has had a stroke or transient ischemic attack (TIA) within 6 months prior to the index procedure .\n12. Subject with active bleeding disorder, active coagulopathy, or any other reason, who is ineligible for DAPT.\n13. Subject is currently participating or plans to participate in another study with an investigational device or an investigational drug\n\nAngiographic Exclusion Criteria:\n\n1. Target vessel has been previously treated and the target lesion is within 5 mm proximal or distal to the previously treated lesion.\n2. Left main coronary artery disease\n3. Target lesion was totally occluded (100% stenosis)\n4. Thrombus in target vessel\n5. Future planned staged PCI either in target or non-target vessel\n6. Ostial target lesion within the left descending (LAD), left circumflex (LCx), or right coronary artery (within 5.0 mm of vessel origin)\n7. Target lesion involves a side branch ≥ 2.0 mm in diameter that requires a two-device strategy after pre-dilatation.\n8. Target lesion is located in or supplied by an arterial or venous bypass graft.\n9. Target lesion with excessive tortuosity proximal to or within the lesion based on visual estimation or heavily calcified target lesion which cannot be adequately pre-dilated by a non-compliant and\u002For cutting\u002Fscoring balloon as described in angiographic exclusion criteria 10.\n10. The target lesion requires treatment with the device other than the non-compliant balloon and\u002For cutting\u002Fscoring balloon prior to scaffold placement (including but not limited to atherectomy devices, intravascular lithotripsy, drug-coated balloons etc.)\n11. Target vessel was treated with brachytherapy any time prior to the index procedure.\n12. Unsuccessful pre-dilatation, defined as residual stenosis \\> 20% (by visual estimation) and \u002F or angiographic complications (e.g. distal embolization, side branch closure, flow-limiting dissections)","ALL","18 Years","80 Years",{"count":21,"type":22},100,"ESTIMATED","INTERVENTIONAL",[25],"NA","The study objective is the assessment of safety and clinical performance of Freesolve 35- and 40-mm in de novo coronary artery lesions up to 38 mm length.",[28,29,30,31,32,33],"Coronary Artery Disease","Atherosclerosis of Coronary Artery","Myocardial Ischemia","Ischemic Heart Disease","Acute Coronary Syndromes","Angina Pectoris",[35,36,37,38],"Resorbable Magnesium Scaffold","Sirolimus","RMS","Drug eluting absorbable metal scaffold","RECRUITING","2025-11-20",{"date":42,"type":43},"2025-11-21","ACTUAL",{"date":45,"type":43},"2025-02-18",{"date":47,"type":22},"2031-06",{"name":49,"class":50},"Biotronik AG","INDUSTRY",8,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":4,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":23,"phases":61,"briefSummary":63,"conditions":64,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":76},"100575058","phase-4-comparison-of-moderate-intensity-statin-plus-ezetimibe-vs-high-intensity-statin-for-coronary-plaque-stabilization-100575058","NCT06767345","Comparison of Moderate-Intensity Statin Plus Ezetimibe vs. High-Intensity Statin for Coronary Plaque Stabilization","Comparing the Moderate Intensity STatin With Ezetimibe COmbination TheraPy With High Intensity Statin Monotherapy on Coronary PLAQUE Stabilization","Inclusion Criteria:\n\n* Adult men and women over the age of 18 years.\n* Patients with coronary artery disease undergoing a coronary intervention procedure using intravascular imaging.\n* At least one major native coronary artery (\"target vessel\") meeting all the following criteria for intracoronary imaging immediately following a qualifying PCI procedure:\n\n  * Angiographic evidence of coronary artery stenosis ≥30% by angiographic visual estimation.\n  * Target vessel is accessible to the imaging catheter and suitable for intracoronary imaging in the proximal 50 mm segment.\n  * Target vessel is not a bypass graft (aortic or arterial) or a bypassed graft vessel.\n  * Target vessel has not undergone PCI within the target segment.\n  * Target vessel is not a candidate for PCI at the time of the procedure or for 6 months thereafter (per investigator's judgment).\n* Patients who have provided written informed consent to participate in the study.\n\nExclusion Criteria:\n\n* Left main stem lesion: Left main coronary artery stenosis ≥50% by coronary angiographic visual estimation.\n* History of coronary artery bypass graft surgery (CABG).\n* Unstable clinical condition (hemodynamic or electrical instability).\n* Severe coronary artery calcification or tortuosity interfering with IVUS, NIRS, or evaluation.\n* Uncontrolled cardiac arrhythmia (recurrent and symptomatic ventricular tachycardia or atrial fibrillation with rapid ventricular response) not controlled by medication within 3 months prior to screening.\n* Active liver disease or liver dysfunction.\n* Severe renal dysfunction (eGFR \\\u003C30 mL\u002Fmin\u002F1.73m²)\n* Known allergy to contrast media, heparin, aspirin, ticagrelor, or prasugrel.\n* Active infection or major hematologic, metabolic, or endocrine dysfunction as determined by the investigator.\n* Planned surgery within 12 months.\n* Currently enrolled in another investigational device or drug study.\n* Estimated life expectancy of less than 2 years.\n* Women of childbearing potential (under 50 years of age) who:\n\n  * Had their last menstrual period within the last 12 months.\n  * Have not had tubal ligation, oophorectomy, or hysterectomy.",{"count":60,"type":22},408,[62],"PHASE4","This study is a prospective, multicenter, randomized clinical trial aimed at comparing the effects of moderate-intensity statin plus ezetimibe combination therapy versus high-intensity statin monotherapy on coronary plaque stabilization. Using advanced imaging techniques such as near-infrared spectroscopy-intravascular ultrasound (NIRS-IVUS), the trial evaluates whether the combination therapy is non-inferior to monotherapy in stabilizing coronary plaques over 52 weeks. The primary endpoint is the percentage change in coronary atheroma volume (PAV) assessed by grayscale IVUS, with secondary outcomes including changes in lipid core burden, inflammatory markers, and clinical events like myocardial infarction and ischemic stroke. The study plans to enroll 408 patients undergoing coronary intervention across 7 domestic institutions, with rigorous follow-up protocols and adherence to international research guidelines.",[28,29,65],"Plaque, Atherosclerotic","2025-09-08",{"date":68,"type":43},"2025-09-15",{"date":70,"type":43},"2025-05-12",{"date":72,"type":22},"2028-06-25",{"name":74,"class":75},"Korea University Anam Hospital","OTHER",1,{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":17,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":88,"studyType":89,"phases":4,"briefSummary":90,"conditions":91,"keywords":92,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":76},"100582206","immunoregulation-in-atherosclerosis-a-single-cell-rna-sequencing-study-100582206","NCT06860295","\"Immunoregulation in Atherosclerosis: A Single-Cell RNA Sequencing Study\"","The Architectural Immunoregulation in Atherosclerotic Disease: A Single-Cell RNA Sequencing and Spatial Biology Approach","Inclusion Criteria:\n\n* Patients diagnosed with ischemic cardiomyopathy due to advanced atherosclerosis, undergoing heart transplantation;\n* Patients with coronary artery disease submitted to coronary artery bypass graft surgery (CABG).\"\n* Aged between 40 and 75 years;\n* Signed informed consent form.\n\nExclusion Criteria:\n\n* Patients with systemic inflammatory or autoimmune diseases;\n* History of cancer within the last 5 years or active malignancy;\n* Recent use (within the last 6 months) of immunosuppressive therapy.","45 Years","75 Years",{"count":87,"type":22},30,"2 Years","OBSERVATIONAL","Atherosclerosis is the leading cause of acute cardiovascular events, such as myocardial infarction and stroke, and is a significant risk factor for cardiovascular mortality. The detailed understanding of the immune mechanisms and cellular transformations involved in the pathogenesis of atherosclerosis is still limited, and the use of single-cell RNA sequencing (scRNAseq) has revealed new cellular functions and subpopulations associated with disease progression. This study aims to identify cellular subpopulations, molecular pathways, and changes in gene expression related to the development of atherosclerosis in human coronary arteries. Using scRNAseq, the study seeks to characterize the transcriptomic landscape of cells present in atherosclerotic plaques and identify molecular signatures that reveal individual predispositions to specific phenotypes, such as disease susceptibility and response to therapies. The research will be conducted at the Albert Einstein Israeli Hospital in São Paulo and will involve samples from coronary arteries and atherosclerotic plaques of the explanted hearts of patients who have undergone heart transplants as well as from discarded material of coronary artery bypass graft surgery (CABG). With an estimated sample size of 20-30 plaques, the data obtained will allow for a detailed analysis of the molecular mechanisms involved in atherosclerosis, contributing to the development of specific therapeutic targets.",[29],[93,94,95],"Atherosclerosis","Single Cell RNA-sequencing","Immunology","NOT_YET_RECRUITING","2025-06-09",{"date":99,"type":43},"2025-06-10",{"date":101,"type":22},"2025-06-25",{"date":103,"type":22},"2027-04-25",{"name":105,"class":75},"Hospital Israelita Albert Einstein"]