[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"coronary-arterial-disease-cad\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:coronary-arterial-disease-cad":27},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,63,0,25,[9,46,79,103,127,160,182,205,232,259,292,318,339,376,402,433,462,482,509,536,564,590,619,639,667],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100589831","agent-dcb-stance-safety-and-effectiveness-study-of-agent-drug-coated-balloon-compared-to-standard-of-care-percutaneous-coronary-intervention-pci-treatment-for-de-novo-coronary-lesions-100589831",false,"NCT06959524","AGENT DCB STANCE: Safety and Effectiveness Study of AGENT Drug-Coated Balloon Compared to Standard of Care Percutaneous Coronary Intervention (PCI) Treatment for de Novo Coronary Lesions","AGENT DCB STANCE: AGENT Drug-Coated Balloon for STent AvoidANCE in PCI for De Novo Coronary Artery Disease","Clinical Inclusion Criteria:\n\n* Subject must be at least 18 years of age.\n* Subject (or legal guardian) understands the trial requirements and the treatment procedures and provides written informed consent before any trial-specific tests or procedures are performed.\n* Subject is eligible for percutaneous coronary intervention (PCI).\n* Subject is willing to comply with all protocol-required follow-up evaluation.\n* Women of child-bearing potential must agree to use a reliable method of contraception from the time of screening through 12 months after the index procedure.\n\nAngiographic Inclusion Criteria:\n\n* Target lesion is a de novo lesion located in a native coronary artery\n* Target lesion must have visually estimated stenosis \\> 50% and \\\u003C 100% in symptomatic subjects (\\>70% and \\\u003C100% in asymptomatic subjects) prior to lesion pre-dilation.\n* Target lesion must be successfully pre-dilated.\n* If a non-target lesion is treated, it must be treated first and must be deemed a success.\n\nClinical Exclusion Criteria:\n\n* Subject has other serious medical illness (e.g. cancer, congestive heart failure) that may reduce life expectancy to less than 12 months.\n* Subject has current problems with substance abuse (e.g. alcohol, cocaine, heroin, etc.).\n* Subject has planned procedure that may cause non-compliance with the protocol or confound data interpretation.\n* Subject is participating in another investigational drug or device clinical study that has not reached its primary endpoint.\n* Subject intends to participate in another investigational drug or device clinical study within 12 months after the index procedure.\n* Subject is a woman who is pregnant or nursing. A pregnancy test must be performed within 7 days prior to the index procedure, except for women who definitely do not have child-bearing potential.\n* Subject has left ventricular ejection fraction known to be \\\u003C 30%.\n* Subject had PCI or other coronary interventions within the last 30 days.\n* Subject has planned PCI or CABG after the index procedure.\n* Subject had STEMI or QWMI \\\u003C72h prior to the index procedure.\n* Subject presents with NSTEMI and rising biomarkers, or ongoing chest pain or is hemodynamically unstable.\n* Subject has cardiogenic shock (SBP \\\u003C 80 mmHg requiring inotropes, IABP or fluid support).\n* Subject has history (within 6 months prior to the index procedure) of New York Heart Association (NYHA) class III or IV heart failure.\n* Subject is considered not able to tolerate at least 30 seconds of coronary occlusion of the target lesion.\n* Subject has known allergy to paclitaxel or other components of the used medical devices.\n* Subject has known hypersensitivity or contraindication to contrast dye that in the opinion of the investigator cannot be adequately pre-medicated.\n* Subject has intolerance to antiplatelet drugs, anticoagulants required for procedure.\n* Subject has platelet count \\\u003C 100k\u002Fmm3 (risk of bleeding) or \\> 700k\u002Fmm3.\n* Subject with renal insufficiency (creatinine ≥2.0 mg\u002Fdl) or failure (dialysis dependent).\n\nAngiographic Exclusion Criteria:\n\n* In-stent restenosis.\n* Target lesion is located within a saphenous vein or arterial graft.\n* Target lesion is a total occlusion or has evidence of thrombus present in the target vessel.\n* Target lesion is severely calcified by angiography or has \\> 270° calcium arc on intravascular imaging or requires atherectomy.\n* Subject has unprotected left main coronary artery disease (\\>50% diameter stenosis) or three-vessel coronary disease requiring revascularization of all 3 vessels.\n* Subject with planned treatment of lesion involving aortic ostial location.","ALL","18 Years",{"count":20,"type":21},1616,"ESTIMATED","INTERVENTIONAL",[24],"NA","AGENT DCB STANCE is a prospective, multicenter, open-label, 1:1 randomized controlled study designed to assess the safety and effectiveness of a treatment strategy with the AGENT Drug-Coated Balloon compared to standard of care percutaneous coronary intervention (PCI) treatment with drug eluting stent (DES) and\u002For balloon angioplasty in patients with de novo coronary lesions.\n\nSubjects must have a de novo target lesion located in a native coronary artery.",[27,28],"Coronary Arterial Disease (CAD)","de Novo Lesions in Native Coronary Arteries",[30,31,32],"Drug Coated Balloon","de novo","97279374","RECRUITING","2026-07-01",{"date":36,"type":37},"2026-07-02","ACTUAL",{"date":39,"type":37},"2025-08-21",{"date":41,"type":21},"2032-03",{"name":43,"class":44},"Boston Scientific Corporation","INDUSTRY",62,{"id":47,"slug":48,"hasResults":12,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":78},"100642157","evaluation-of-calcified-coronary-lesion-preparation-with-the-naviscore-scoring-balloon-100642157","NCT07650578","Evaluation of Calcified Coronary Lesion Preparation With the Naviscore Scoring Balloon","MILOU: Minimize Intra Luminal Obstructive Underexpansion: A Prospective, Multi-Center Randomized Trial for the Evaluation of Calcified Coronary Lesion Preparation With the Naviscore Scoring Balloon","MILOU","Inclusion Criteria:\n\n* Patient written consent is given, ≥18 years.\n* A de novo lesion to be treated in a vessel between 2.5 and 4.0 mm.\n* Moderate to heavily calcified lesions detected by coronary angiography on two orthogonal views, and confirmed by IVUS if the lesion can be crossed with the catheter.\n\nExclusion Criteria:\n\n* Patient \\\u003C18 years old.\n* Pregnant female.\n* Contraindication to dual antiplatelet therapy.\n* Thrombocytopenia (under 100 000).\n* Major surgical intervention planned within one year.\n* Significant left main lesion.\n* Chronic total occlusion.\n* Lesion in a graft.\n* In-stent restenosis lesion.\n* Lesion responsible of a ST elevated Myocardial Infarction (STEMI)",{"count":55,"type":21},200,[24],"The purpose of this clinical study is to evaluate the effectiveness and safety of a specialized medical device, the Naviscore scoring balloon, in preparing calcified coronary artery narrowings before the implantation of a drug-eluting stent. During percutaneous coronary interventions, the presence of calcified plaques in the heart arteries represents a major challenge because it can prevent stents from expanding fully. When a stent remains under-expanded, it significantly increases the long-term risk of arterial re-narrowing or blood clot formation. To optimize stent expansion, appropriate preparation of the diseased vessel section before stent insertion is a critical phase.\n\nThis study is a prospective, multi-center randomized trial designed to test the hypothesis that treating calcified coronary lesions with the Naviscore scoring balloon will achieve a better stent expansion and a larger final minimal stent area compared to standard lesion preparation using regular non-compliant balloons. Eligible participants will be randomized in a one-to-one ratio to one of these two lesion preparation strategies. For all included patients, standard drug-eluting stents will be deployed. The study will use intravascular ultrasound imaging to evaluate the final minimum area of the stent directly inside the treated artery at the site of the highest initial calcium burden. Participant health and clinical outcomes will be monitored for up to twelve months following the procedure.",[27,59],"Calcific Coronary Arteriosclerosis",[61,62,63,64,65,66],"Percutaneous Coronary Intervention","Lesion Preparation","Scoring Balloon","Intravascular Ultrasound","Stent Expansion","Coronary Artery Calcification","NOT_YET_RECRUITING","2026-06-10",{"date":70,"type":37},"2026-06-16",{"date":72,"type":21},"2026-07",{"date":74,"type":21},"2028-06",{"name":76,"class":77},"University of Mons","OTHER",14,{"id":80,"slug":81,"hasResults":12,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":87,"targetDuration":89,"studyType":90,"phases":4,"briefSummary":91,"conditions":92,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":4},"100642512","opn-balloon-for-safe-recanalization-of-calcified-coronary-lesions-100642512","NCT07646444","OPN Balloon for SAFE Recanalization of Calcified Coronary Lesions","OPN Balloon for SAFE Recanalization of Calcified Coronary Lesions (OPEN-SAFE Registry)","OPEN-SAFE","Inclusion Criteria:\n\n* Age 18 years or older\n* Subjects who underwent a clinically indicated PCI procedure that involved at least one OPN balloon\n* Date range for data collection will be from February 1, 2023 to December 31, 2028\n\nExclusion Criteria:\n\n* Subjects who have opted out of being included in research related data collection",{"count":88,"type":21},300,"1 Week","OBSERVATIONAL","The goal of the OPEN-SAFE registry is to describe the contemporary use and outcomes of SIS-OPN in North America.",[27,93,94],"In Stent Restenosis","Calcified Coronary Lesions",{"date":96,"type":37},"2026-06-12",{"date":98,"type":21},"2026-06",{"date":100,"type":21},"2027-06",{"name":102,"class":77},"Minneapolis Heart Institute Foundation",{"id":104,"slug":105,"hasResults":12,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":4,"eligibilityCriteria":109,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":110,"targetDuration":4,"studyType":22,"phases":112,"briefSummary":113,"conditions":114,"keywords":115,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":126},"100567001","forward-cad-ide-study-100567001","NCT06662500","FORWARD CAD IDE Study","Prospective, Multicenter, Single-Arm, Investigational Device Exemption (IDE) Study of the Shockwave Intravascular Lithotripsy (IVL) System With the Shockwave Javelin Coronary IVL Catheter (FORWARD CAD IDE Study)","General Inclusion Criteria:\n\n1. Subject is ≥18 years of age\n2. Subject is able and willing to comply with all assessments in the study.\n3. Subjects with native coronary artery disease including stable angina or following stabilization after acute coronary syndromes (ACS) for non-emergent percutaneous coronary intervention (PCI)\n4. Biomarkers (troponin) must be:\n\n   1. less than or equal to the upper limit of lab normal within 24 hours prior to the procedure or may be drawn from the side port of the sheath at the time of index if the PCI is a non-emergent procedure and has stable angina (result will not be known prior to procedure); OR\n   2. if above the upper limit of lab normal, biomarker result must be less than 5 times the upper limit of lab normal within 24 hours prior to the procedure and the following criteria must be met: • The procedure must not be emergent and the subject cannot have angina at rest.\n5. Left ventricular ejection fraction (LVEF) \\>30% within 6 months (note: in the case of an event (MI or Revascularization) the LVEF must be taken post-event and in the case of multiple assessments of LVEF, the measurement closest to enrollment will be used for this criterion; may be assessed at time of index procedure).\n6. Subject, or legally authorized representative, signs a written Informed Consent form to participate in the study, prior to any study-mandated procedures.\n7. Estimated life expectancy \\>1 year.\n8. Lesions in non-target vessels requiring PCI may be treated either:\n\n   1. \\>30 days prior to the study procedure if the procedure was unsuccessful or complicated; OR\n   2. \\>24 hours prior to the study procedure if the procedure was successful and uncomplicated (defined as a final lesion angiographic diameter stenosis \\\u003C30% and TIMI 3 flow (visually assessed) for all non-target lesions and vessels without perforation, cardiac arrest or need for defibrillation or cardioversion or hypotension\u002Fheart failure requiring mechanical or intravenous hemodynamic support or intubation, and no evidence of elevated biomarkers post-procedure; OR\n   3. \\>30 days after the study procedure\n\n   Angiographic Inclusion Criteria\n9. The target lesion must be a de novo coronary lesion that has not been previously treated successfully with any interventional procedure\n10. Single de novo target lesion stenosis of protected LMCA, or LAD, RCA or LCX (or of their branches)\n11. The target vessel reference diameter must be ≥2.5 mm and ≤4.0 mm\n12. The target lesion must meet one of the following criteria:\n\n    1. Target lesion stenosis \\>90% up to 40 mm in length and evidence of moderate or severe calcification at the lesion site. Moderate calcification defined as angiography with densities noted only during the cardiac cycle prior to contrast injection; severe calcification defined as angiography with fluoroscopic radio-opacities noted without cardiac motion prior to contrast injection involving both sides of the arterial wall; OR\n    2. Chronic total occlusion presenting with J-CTO score of 1 with evidence of calcification and occlusion length up to 20 mm.\n13. Guidewire must be in true lumen, distal to the lesion, and not subintimal, prior to insertion of Shockwave Javelin Coronary IVL catheter (antegrade wire technique only)\n\nGeneral Exclusion Criteria:\n\n1. Any comorbidity or condition which may prevent compliance with this protocol, including follow-up visits\n2. Subject is participating in another research study involving an investigational agent including pharmaceutical, biologic, or medical device that has not reached the primary endpoint\n3. Subject is pregnant or nursing (a negative pregnancy test is required for women of child-bearing potential within 7 days prior to enrollment)\n4. Unable to tolerate antiplatelet\u002Fanticoagulation therapy per society guidelines\n5. Subject has an allergy to imaging contrast media which cannot be adequately pre-medicated\n6. Subject experienced an acute STEMI within 30 days prior to index procedure\n7. New York Heart Association (NYHA) class III or IV heart failure\n8. Subject has acute or chronic renal disease with eGFR \\\u003C30 ml\u002Fmin\u002F1.73m2 (using institutional formula)\n9. History of a stroke or transient ischemic attack (TIA) within 60 days, or any prior intracranial hemorrhage or permanent neurologic deficit\n10. Active peptic ulcer or upper gastrointestinal (GI) bleeding within 3 months\n11. Untreated pre-procedural hemoglobin \\\u003C10 g\u002FdL or intention to refuse blood transfusions if one should become necessary\n12. Coagulopathy, including but not limited to platelet count \\\u003C100,000 or International Normalized ratio (INR) \\>1.7 (INR is only required in subjects who have taken warfarin within 2 weeks of enrollment)\n13. Subject has a hypercoagulable disorder such as polycythemia vera, platelet count \\>750,000 or other disorders\n14. Subject has an active systemic infection on the day of the index procedure with either fever, leukocytosis or requiring intravenous antibiotics\n15. Subjects with clinical evidence of cardiogenic shock\n16. Uncontrolled severe hypertension (systolic BP \\>180 mm Hg or diastolic BP \\>110 mm Hg)\n17. Subjects with an estimated life expectancy of less than 1 year\n18. Non-coronary interventional or surgical structural heart procedures (e.g., TAVR, MitraClip, LAA or PFO occlusion, etc.) within 30 days prior to the index procedure\n19. Planned non-coronary interventional or surgical structural heart procedures (e.g., TAVR, MitraClip, LAA or PFO occlusion, etc.) within 30 days after the index procedure\n20. Subject refusing or not a candidate for emergency coronary artery bypass grafting (CABG) surgery\n21. Planned use of atherectomy, scoring or cutting balloon, sub-intimal reentry device, or any investigational device other than coronary IVL\n\n    Angiographic Exclusion Criteria\n22. Unprotected left main diameter stenosis \\>30%\n23. Evidence of a serious angiographic complication in the target vessel prior to treatment with coronary IVL (dissection, perforation, abrupt closure, persistent slow-flow or persistent no reflow)\n24. Definite or possible thrombus by angiography in the target vessel\n25. Evidence of aneurysm in target vessel within 10 mm of the target lesion\n26. Second lesion with \\>50% stenosis in the same target vessel as the target lesion including its side branches\n27. Chronic total occlusion of the target lesion, J-CTO ≥2\n28. Target lesion is located in a native vessel that can only be reached by going through a saphenous vein or arterial bypass graft\n29. Previous stent within 5 mm of the target lesion\n30. Failure to successfully cross the guidewire across the target lesion\n31. Planned use of antegrade dissection and reentry (ADR), retrograde guidewire (RW), or retrograde dissection and reentry (RDR) crossing technique at any time during the procedure.",{"count":111,"type":21},408,[24],"The FORWARD CAD IDE Study is a Prospective, Multicenter, Single-Arm, Investigational Device Exemption (IDE) Study conducted to assess the safety and effectiveness of the Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Coronary IVL Catheter for the treatment of calcified, stenotic de novo coronary artery lesions prior to stenting.",[27],[116],"Intravascular Lithotripsy","2026-06-01",{"date":119,"type":37},"2026-06-03",{"date":121,"type":37},"2025-04-04",{"date":123,"type":21},"2027-12",{"name":125,"class":44},"Shockwave Medical, Inc.",34,{"id":128,"slug":129,"hasResults":12,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":133,"eligibilityCriteria":134,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":135,"targetDuration":137,"studyType":90,"phases":4,"briefSummary":138,"conditions":139,"keywords":141,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":159},"100586058","artificial-intelligence-based-timing-infarct-size-and-outcomes-in-acute-coronary-occlusion-myocardial-infarction-100586058","NCT06910436","Artificial Intelligence Based Timing, Infarct Size and Outcomes in Acute Coronary Occlusion Myocardial Infarction","Artificial Intelligence Based Timing, Infarct Size and Outcomes in Acute Coronary Occlusion Myocardial Infarction Without ST Elevation","ANOMI","Inclusion Criteria:\n\n* Age \\> 18 yrs\n* Working diagnosis of Non- ST Elevation Acute Coronary Syndrome after the assessment by specialist\n\nExclusion Criteria:\n\n* ST-Elevation Myocardial infarction\n* Age \\\u003C 18 yrs\n* Major sustained ventricular arrhythmias\n* Corrupted ECG images\n* Poor digitalisation quality of the ECG",{"count":136,"type":21},1500,"12 Months","The present study is practice-driven and merely observational and prospective. In clinical routine, patients who suffer from suspected ACS and do not show ST elevation in the ECG, different timing proposals in the guidelines and logistically driven differences lead to considerably variable timings in invasive coronary anatomy assessments. This handling may lead to larger infarct sizes when OMI is overseen. Therefore, the present study aims to observe a) whether an AI model is capable of correctly identify OMI in eligible patients and b) if in these patients troponin peak levels vary depending on the elapsed time between OMI diagnosis and coronary intervention.\n\nAs the model has not been established yet clinically and in the guidelines, it is safe to assume the usual pathway from first medical contact to specialist's attention is undertaken. When a patient presents in an emergency department or places an emergency call, the physicians assess the situation as usal and as stated in the current guidelines1.\n\nIf no STEMI is confirmed, the NSTE-ACS protocol is started. The patients who are ruled out for ACS are excluded from the final analysis (screening). In this case, the AI model is tested on their ECG in order to assess whether there are false positives.\n\nThe patients which are in the ACS \"rule-in\" trail and undergo final coronary angiography will naturally be divided in patients which were classified as OMI and as non-OMI by the AI model. Furthermore, they will present a different \"Time from OMI diagnosis to PCI) and variable troponin peak levels.\n\nBy leveraging this natural variability, a practical distinction and multiple analyses can be done:\n\n1. The feasibility of AI-powered ECG interpretation in the care of patients with suspected ACS and without clear ST-elevation infarction\n2. The accuracy of AI-powered ECG interpretation in detecting OMI compared to the classical STEMI criteria\n3. How infarct size correlates with different ECG readings by AI and (hypothesis generating) if changing the clinical practice could lead to a benefit in patients with suspected OMI.",[27,140],"Acute Coronary Syndrome (ACS) Undergoing Percutaneous Coronary Intervention (PCI)",[142,143,144,145,146,147,148,149,61],"Artificial Intelligence","ECG","AI","NSTE-ACS","ACS","Acute Coronary Syndrome","Reperfusion times","PCI","2026-05-21",{"date":152,"type":37},"2026-05-26",{"date":154,"type":37},"2024-04-01",{"date":156,"type":21},"2026-07-31",{"name":158,"class":77},"Azienda Ospedaliera di Bolzano",1,{"id":161,"slug":162,"hasResults":12,"nctId":163,"briefTitle":164,"officialTitle":164,"acronym":165,"eligibilityCriteria":166,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":167,"targetDuration":169,"studyType":90,"phases":4,"briefSummary":170,"conditions":171,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":174,"startDateStruct":176,"completionDateStruct":178,"leadSponsor":180,"locationsCount":159},"100586760","optimal-stent-deployment-strategy-of-contemporary-stents---registry-to-evaluate-percutaneous-coronary-intervention-using-bioresorbable-scaffolds-with-thinner-strut-construction-and-guidance-by-intracoronary-imaging-to-reduce-scaffold-failure-100586760","NCT06919562","OPtimal stEnt Deployment stRategy oF Contemporary sTents - Registry to Evaluate Percutaneous Coronary Intervention Using Bioresorbable Scaffolds With Thinner-strut Construction and Guidance by intracOronary Imaging to REduce Scaffold Failure","PERFECTRESTORE","Inclusion Criteria:\n\n1. Stable coronary artery disease with one or more significant epicardial stenosis in native coronary arteries suitable for OCT or IVUS-guided PCI with BRS implantation.\n2. Subject must be at least 18 years of age\n3. Written consent to participate in the study\n\nExclusion Criteria:\n\n1. Culprit lesions in the setting of acute coronary syndrome.\n2. Lesions with severe calcification.\n3. Lesions in a coronary artery with severe tortuosity.\n4. Left main coronary artery lesions.\n5. Bifurcation lesions.\n6. Ostial lesions.\n7. Lesions with a difference in proximal and distal reference diameter of \\>0.5 mm by visual judgement of the coronary angiogram by the treating operator.\n8. Treatment of in-stent restenosis or stent thrombosis.\n9. History of definite stent thrombosis.\n10. Lesions in coronary artery bypass grafts.\n11. Lesions not suitable for OCT or IVUS catheter delivery and imaging, e.g. due to tortuosity or distal localisation.\n12. Creatinine Clearance ≤ 30 ml\u002Fmin\u002F1.73 m2 as calculated by MDRD formula for estimated GFR.\n13. Contraindication to dual antiplatelet therapy with aspirin and a P2Y12 inhibitor or (if indicated) NOAC and P2Y12 inhibitor.\n14. Planned non-deferrable major surgery after PCI.\n15. Known comorbidity associated with a life expectancy \\\u003C1 year.\n16. Unable to understand and follow study-related instructions or unable to comply with study protocol.",{"count":168,"type":21},117,"3 Years","Implantation of a metallic drug-eluting stent (DES) is currently the gold standard in percutaneous coronary intervention (PCI). However, a DES has several limitations on the long-term, such as chronic local inflammation which may lead to in-stent restenosis, absence of physiological coronary vasomotion and vessel caging which makes future coronary artery bypass grafting (CABG) impossible. A bioresorbable scaffold (BRS) is designed to overcome these limitations. The first generation BRS was shown to be clinically inferior to DES due to a slightly higher rate of stent thrombosis. To overcome this problem, several scientific developments have been achieved in the past few years, such as thinner BRS strut construction and improved implantation technique by using PSP (predilatation, sizing, postdilatation) method and intracoronary imaging guidance with optical coherence tomography (OCT) or intravasculair ultrasound (IVUS). A PCI protocol that combines implantation of a second generation thin-strut BRS, mandatory PSP implantation method and mandatory intracoronary imaging-guidance has not yet been investigated. The aim of this study is to investigate feasibility of a new PCI protocol with implantation of the second generation Meres100 thin-strut BRS combined with a protocolized PSP implantation technique guided by intracoronary imaging.",[27,172],"Percutaneous Coronary Intervention (PCI)","2026-05-15",{"date":175,"type":37},"2026-05-18",{"date":177,"type":37},"2025-11-04",{"date":179,"type":21},"2030-08",{"name":181,"class":77},"Albert Schweitzer Ziekenhuis, Netherlands",{"id":183,"slug":184,"hasResults":12,"nctId":185,"briefTitle":186,"officialTitle":187,"acronym":188,"eligibilityCriteria":189,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":190,"targetDuration":4,"studyType":22,"phases":192,"briefSummary":193,"conditions":194,"keywords":195,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":197,"lastUpdatePostDateStruct":198,"startDateStruct":199,"completionDateStruct":201,"leadSponsor":202,"locationsCount":204},"100632188","avs-pulse-intravascular-lithotripsy-pulse-ivl-to-open-vessels-with-calcific-walls-and-enhance-vascular-compliance-and-remodeling-for-coronary-artery-disease-100632188","NCT07510438","AVS Pulse Intravascular Lithotripsy™ (Pulse IVL™) to Open Vessels With Calcific Walls and Enhance Vascular Compliance and Remodeling for Coronary Artery Disease","AVS Pulse Intravascular Lithotripsy™ (Pulse IVL™) to Open Vessels With Calcific Walls and Enhance Vascular Compliance and Remodeling for Coronary Artery Disease - A First-in-Human (FIH) Study","POWER CAD I","Key Inclusion Criteria:\n\n* ≥ 18 years of age\n* Subjects with native coronary artery disease\n* Left ventricular ejection fraction (LVEF) ≥ 35% within 6 months\n* The target lesion must be a single de novo coronary lesion\n* The target lesion stenosis of left anterior descending artery (LAD), right coronary artery (RCA), left circumflex artery (LCX), or ramus intermedius (RI), or of their branches with Stenosis of ≥70% and \\\u003C100% or Stenosis ≥50% and \\\u003C70% with evidence of ischemia\n* Lesion length must not exceed 44 mm\n\nKey Exclusion Criteria:\n\n* Subject experienced an acute Myocardial Infarction (MI), either ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI) within 30 days prior to index procedure.\n* Subject has New York Heart Association (NYHA) class III or IV heart failure.\n* Subject has renal failure with serum creatinine \\>2.5 mg\u002FdL, or chronic dialysis.\n* Subject has a previous stent in the target vessel implanted within last six months.\n* Unprotected LMCA diameter stenosis \\>30%.\n* Target lesion has a myocardial bridge.\n* Target vessel is excessively tortuous, defined as the presence of 2 or more bends \\>90 degrees or 3 or more bends \\>75 degrees.\n* Evidence of aneurysm in target vessel within 10 mm of the target lesion.\n* Target lesion in ostial location (LAD, RCA, LCX, or RI, within 5 mm of ostium) or in an unprotected LMCA.\n* Target lesion is a bifurcation with ostial diameter stenosis ≥30%.\n* Any previous stent within 10 mm of the target lesion.",{"count":191,"type":21},15,[24],"A prospective, open-label, multi-site, FIH with up to fifteen (n=15) patients to assess the safety and preliminary effectiveness of the AVS Pulse Intravascular Lithotripsy™ System (Pulse IVL™ System) when used for the treatment of coronary artery disease.",[27],[116,196],"IVL","2026-05-14",{"date":175,"type":37},{"date":200,"type":37},"2026-05-08",{"date":123,"type":21},{"name":203,"class":44},"Amplitude Vascular Systems, Inc.",2,{"id":206,"slug":207,"hasResults":12,"nctId":208,"briefTitle":209,"officialTitle":210,"acronym":211,"eligibilityCriteria":212,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":213,"targetDuration":4,"studyType":22,"phases":215,"briefSummary":217,"conditions":218,"keywords":219,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":223,"lastUpdatePostDateStruct":224,"startDateStruct":226,"completionDateStruct":228,"leadSponsor":230,"locationsCount":159},"100610304","phase-4-the-bridging-antiplatelet-therapy-with-cangrelor-2-study-100610304","NCT07225842","The Bridging Antiplatelet Therapy With Cangrelor 2 Study","The Bridging Antiplatelet Therapy With Cangrelor 2 (BRIDGE 2) Study: A Pilot Prospective Cohort, Pharmacodynamic Study of Tailored Cangrelor Bridging Dosing Regimens","BIRDGE 2","Inclusion Criteria:\n\n1. Any patient receiving bridging with standard-dose cangrelor infusion rate of 0.75 mcg\u002FKg\u002Fmin for at least two hours as part of their standard of care.\n2. Age ≥18 years\n3. Provide written informed consent.\n\nExclusion Criteria:\n\n1. Need for urgent surgery\n2. Confirmed or suspected pregnancy (in woman of child-bearing potential) or lactating females\n3. Exposure to any oral P2Y12 inhibitor, oral anticoagulant or glycoprotein IIb\u002FIIIa inhibitor within 48 hours.\n4. Known allergy, and hypersensitivity, or contraindication to cangrelor, mannitol, sorbitol, or microcrystalline cellulose",{"count":214,"type":21},50,[216],"PHASE4","The primary aim of this study is to determine rates of patients with optimal platelet reactivity range, defined as PRU levels between 85 and 208, when using a (PFT)-guided titration of cangrelor infusion rate (cangrelor titration) compared to 0.75 mcg\u002Fkg\u002Fmin (standard-dose infusion) for bridging.",[27],[220,221,222],"coronary artery disease","cangrelor","bridge","2026-04-30",{"date":225,"type":37},"2026-05-05",{"date":227,"type":37},"2026-02-18",{"date":229,"type":21},"2027-11",{"name":231,"class":77},"University of Florida",{"id":233,"slug":234,"hasResults":12,"nctId":235,"briefTitle":236,"officialTitle":237,"acronym":238,"eligibilityCriteria":239,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":240,"targetDuration":4,"studyType":22,"phases":242,"briefSummary":243,"conditions":244,"keywords":247,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":250,"lastUpdatePostDateStruct":251,"startDateStruct":253,"completionDateStruct":255,"leadSponsor":257,"locationsCount":159},"100577629","prolonged-chest-tube-treatment-to-reduce-rates-of-atrial-fibrillation-following-cardiac-surgery-100577629","NCT06800781","Prolonged Chest Tube Treatment to Reduce Rates of Atrial Fibrillation Following Cardiac Surgery","Prolonged Posterior Pericardial Chest Tube Treatment to Reduce Rates of Postoperative Atrial Fibrillation Following Cardiac Surgery","PROPER","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Undergoing non-emergent surgery (\\>24 hours between decision to operate and surgical procedure) with coronary artery bypass grafting, aortic valve replacement, aortic surgery without the use of circulatory arrest, or any combination of these procedures\n* Able to give written informed consent\n\nExclusion Criteria:\n\n* History of atrial fibrillation (AF) or atrial flutter\n* History of electrophysiological interventions or treatment with antiarrhythmic drugs due to arrhythmias other than AF\n* Pre- or postoperative prophylactic treatment with amiodarone\n* Existing pacemaker, ICD, or CRT device without a functional atrial lead\n* Aortic surgery with hypothermic circulatory arrest\n* Previous cardiac surgery\n* Previous radiation of the chest due to malignancy\n* Ongoing infection at time of surgery\n* Ongoing treatment with immunosuppressants, including oral corticosteroids\n* Patient already included in another interventional clinical trial\n* Patient listed abroad, which would render them to be lost to follow-up after discharge\n* Patient does not understand study information given in the local language or, for other reasons, is deemed unfit to participate according to the investigators.",{"count":241,"type":21},624,[24],"Evacuation of pericardial blood by posterior pericardiotomy or use of a posterior pericardial chest tube lowers postoperative atrial fibrillation (POAF) rates after cardiac surgery by 45-68%. Although it cannot be generalized due to trial undersizing, posterior pericardial chest tube treatment may be a superior alternative to pericardiotomy, given its low risk of procedural complications.\n\nThis interventional multicenter trial will assess whether prolonged treatment with a posterior pericardial chest tube lowers POAF rates after cardiac surgery. Investigators will randomize 624 patients undergoing routine cardiac surgery at Nordic sites 1:1 to receive a posterior pericardial chest tube as adjunct to standard care for up to 3 postoperative days or standard care alone. The primary outcome is the proportion of patients with POAF up to 7 days post-surgery; the study will be powered to detect a relative risk reduction of 30% in the intervention arm. Secondary outcomes are AF burden; days with chest tubes and their output; proportion of patients with POAF up to 14 days post-surgery; direct current conversions during hospital admission; length of ICU\u002Fhospital stay; postoperative complications, mortality, ischemic stroke, and major bleeding at 30\u002F90 days and 1\u002F3\u002F5 years; and quality of life\u002Fpostoperative recovery at 90 days and 1 year. This trial may provide quality clinical evidence supporting the adoption of a simple method to prevent POAF, thus reducing healthcare costs.",[27,245,246],"Valve Replacement","Aortic Surgery",[248,249],"Posterior pericardial chest tube","Postoperative atrial fibrillation (POAF)","2026-04-28",{"date":252,"type":37},"2026-04-29",{"date":254,"type":37},"2025-02-10",{"date":256,"type":21},"2033-12",{"name":258,"class":77},"Region Skane",{"id":260,"slug":261,"hasResults":12,"nctId":262,"briefTitle":263,"officialTitle":264,"acronym":265,"eligibilityCriteria":266,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":267,"targetDuration":4,"studyType":22,"phases":268,"briefSummary":269,"conditions":270,"keywords":277,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":284,"lastUpdatePostDateStruct":285,"startDateStruct":286,"completionDateStruct":288,"leadSponsor":289,"locationsCount":291},"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":214,"type":21},[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.",[27,271,272,273,116,274,172,275,276],"Coronary Calcification","Coronary Calcified Nodules","Orbital Atherectomy","Optical Coherence Tomography (OCT)","Chronic Coronary Syndrome","Acute Coronary Syndrome (ACS)",[278,279,280,281,282,274,172,275,276,265,283],"Coronary arterial disease","Coronary calcification","Coronary calcified nodules","Orbital atherectomy","Intravascular lithotripsy","ORBIT SHOCK","2026-04-26",{"date":223,"type":37},{"date":287,"type":37},"2025-06-12",{"date":123,"type":21},{"name":290,"class":77},"Spanish Society of Cardiology",6,{"id":293,"slug":294,"hasResults":12,"nctId":295,"briefTitle":296,"officialTitle":296,"acronym":297,"eligibilityCriteria":298,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":299,"targetDuration":301,"studyType":90,"phases":4,"briefSummary":302,"conditions":303,"keywords":307,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":309,"lastUpdatePostDateStruct":310,"startDateStruct":312,"completionDateStruct":314,"leadSponsor":316,"locationsCount":204},"100634791","spectral-and-ultra-high-resolution-ct-systems-for-non-invasive-detection-of-myocardial-ischemia-stress-ct-perfusion-vs-ffr-ct-100634791","NCT07544277","Spectral and Ultra High Resolution CT Systems for Non-Invasive Detection of Myocardial Ischemia: Stress CT Perfusion VS. FFR-CT","SURE-CT","Inclusion Criteria:\n\n* Patient referred to our hospitals for elective CCTA for ruling out CAD\n* CCTA evidence of moderate stenosis (50-69%) requiring functional assessment according to ESC guidelines\n\nExclusion Criteria:\n\n* hemodynamically unstable conditions,\n* previous revascularization,\n* myocardial infarction,\n* obesity (BMI\\>40 kg\u002Fm2),\n* renal insufficiency (GFR\\\u003C30 mL\u002Fmin),\n* atrial fibrillation or other significant arrhythmias; and\n* other overt cardiovascular diseases affecting CTP performance (e.g., heart failure, severe valvular regurgitation),\n* pregnancy and breastfeeding,\n* contraindications to iodinated contrast agents or regadenoson.",{"count":300,"type":21},142,"24 Months","Coronary artery disease (CAD) is the leading cause of mortality and morbidity worldwide. Coronary Computed Tomography angiography (CCTA) gained a pivotal clinical role for excellent sensitivity in rule-out CAD, but has limited specificity for a tendency to overestimate stenoses and for the lack of information about their hemodynamic impact. Fractional Flow Reserve derived from CT (FFR-CT) and stress CT perfusion (CTP) have been recently proposed to complement CCTA in the non-invasive assessment of myocardial ischemia, increasing the specificity and avoiding unnecessary catheterization. However, on energy-integrating (EID)-CT, FFR-CT has suboptimal performance, while CTP is affected by high radiation exposure. Both these approaches may benefit by the introduction of the new Photon Counting Detector (PCD)-CT technology, but data completely lacks. Aim of the study is to assess the performance of PCD-CT in the identification of significant CAD combining CCTA with FFR-CT and spectral CTP.",[304,305,306,27],"FFR-CT","CT Angiography","CT Perfusion",[304,308,306,27],"Coronary CT angiography","2026-04-15",{"date":311,"type":37},"2026-04-22",{"date":313,"type":21},"2026-09-01",{"date":315,"type":21},"2029-09-01",{"name":317,"class":77},"IRCCS San Raffaele",{"id":319,"slug":320,"hasResults":12,"nctId":321,"briefTitle":322,"officialTitle":323,"acronym":324,"eligibilityCriteria":325,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":326,"targetDuration":4,"studyType":90,"phases":4,"briefSummary":327,"conditions":328,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":309,"lastUpdatePostDateStruct":331,"startDateStruct":333,"completionDateStruct":335,"leadSponsor":337,"locationsCount":159},"100590807","restrospective-analysis-of-mace-in-patients-treated-with-drug-elluting-balloons-100590807","NCT06972225","Restrospective Analysis of MACE in Patients Treated With Drug-elluting Balloons.","Follow-up of MACE in Patients Treated With Drug-eluting Balloons Between 2010 and 2025; a Retrospective Study With Prospective Follow-up From an Institutional Database: EASY-drug-eluting Balloons","EASY-DEB","Inclusion Criteria:\n\n* Adults (\\>=18 years of age)\n* Who underwent a coronary angioplasty with drug-eluting balloon between January 2010 and December 2025\n* Identified in the institutional procedure database\n\nExclusion Criteria:\n\n* Incomplete or non-available data on the post-procedural clinical follow-up\n* Procedures where other devices were used in combination with drug-eluting balloons.",{"count":136,"type":21},"Retrospective analysis of data collected in an institutional database of coronary interventions with use of drug-eluting balloons, with a prospective follow-up for major adverse cardiovascular events and living status.",[27,329,330],"Restenosis, Coronary","Bifurcation Coronary Disease",{"date":332,"type":37},"2026-04-20",{"date":334,"type":37},"2025-06-10",{"date":336,"type":21},"2036-03",{"name":338,"class":77},"Olivier F. Bertrand",{"id":340,"slug":341,"hasResults":12,"nctId":342,"briefTitle":343,"officialTitle":344,"acronym":345,"eligibilityCriteria":346,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":347,"targetDuration":4,"studyType":22,"phases":349,"briefSummary":350,"conditions":351,"keywords":358,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":366,"lastUpdatePostDateStruct":367,"startDateStruct":369,"completionDateStruct":371,"leadSponsor":373,"locationsCount":375},"100588282","intracoronary-cryotherapy-effect-on-stabilization-of-vulnerable-plaque-in-patients-with-stable-angina-or-acs---a-traditional-feasibility-study-100588282","NCT06939374","Intracoronary Cryotherapy Effect on Stabilization of Vulnerable Plaque in Patients With Stable Angina or ACS - A Traditional Feasibility Study","Clinical Investigation of the Efficacy and Safety of Intracoronary Cryotherapy Using the CryoTherapy System (CTS) for High-risk Plaque in Patients With Stable Angina or Acute Coronary Syndrome.","ICECAP","Inclusion Criteria:\n\n* 1\\) Subject is at least 18 years old. 2) Subject has acute cardiac pain\u002Fangina consistent with stable angina or acute coronary syndrome eligible for coronary angiography meeting one of the following criteria:\n\n  1. Non-ST-segment elevation myocardial infarction (NSTEMI) with rise\u002Ffall of cardiac enzymes (troponin I or T) with at least one value above the 99th percentile of the upper reference limit requiring PCI within 72 hours from diagnosis\n  2. Unstable angina\n  3. ST-segment elevation myocardial infarction (STEMI) 3) Successful PCI (defined as diameter stenosis less than 30% and TIMI 3 flow on final angiography without procedural complication) of the culprit lesion.\n\nNOTE: subjects with unstable angina, for whom the culprit lesion as assessed by investigator does not require PCI currently or within the next 6 months (subject treated with optimal medical treatment) can be enrolled in the study.\n\n4\\) Subject has at least one high-risk plaque meeting the criteria below:\n\n1. Located in a non-culprit vessel,\n2. High-risk plaque lesion on CCTA and at least one of the following features:\n\n   1. Presence of low-attenuation plaque (HU\\\u003C50) and\u002For\n   2. Positive remodelling (remodelling index \\>1.1) and\u002For\n   3. Napkin ring sign and\u002For\n   4. Plaque burden ≥70%\n3. Lesion length ≤ 20 mm.\n4. Diameter stenosis on invasive angiography between 30% and 70% on coronary angiogram or negative physiology assessment (FFR\\>0.80 or NHPR\\>0.89).\n5. Reference vessel diameter (RVD) \\\u003C 3.75 mm and \\> 2.50 mm in diameter\n6. Investigator considers that lesions are accessible.\n7. If more than two suitable lesions available, investigator will select the most appropriate lesion for cryotherapy treatment.\n\n   5\\) maxLCBI4mm in the lesion \\> 324.7 6) Subject is able to provide consent and has signed and dated the informed consent form.\n\n   Exclusion Criteria:\n   * 1\\) Subject is hemodynamically unstable (cardiogenic shock, hypotension needing inotropes, hypoxia needing intubation, refractory ventricular arrhythmias, and IABP).\n\n     2\\) Subject has ongoing ST-segment elevation myocardial infarction. 3) Subject had a procedural complication during the ACS PCI procedure. 4) Subject has history of Coronary Artery Bypass Graft (CABG) or planned CABG within 12 months after the index procedure.\n\n     5\\) Subject has known reduced Left Ventricular Ejection Fraction \\\u003C 30%. 6) Subject has known severe valvular heart disease. 7) Subject has known severe renal insufficiency (eGFR \\\u003C30 ml\u002Fmin\u002F1.72 m2). 8) Subject has any life-threatening conditions or medical comorbidity resulting in life expectancy \\\u003C 12 months.\n\n     9\\) Subject is currently participating in another clinical investigation that has not yet reached its primary endpoint.\n\n     10\\) Subject has severe peripheral vascular disease impeding femoral artery access.\n\n     11\\) Subject is pregnant or lactating, or NOT surgically sterile (tubal ligation or hysterectomy) or NOT postmenopausal for at least 6 months or is a female with childbearing potential without effective contraception (pill, patch, ring, diaphragm, implant and intrauterine device).\n\n   Angiographic exclusion criteria:\n   1. Visible distal embolization\u002Fno-reflow following culprit lesions PCI.\n   2. Left main coronary artery disease (visual diameter stenosis \\> 50%).\n   3. Stent thrombosis\u002Frestenosis as a culprit lesion.\n   4. CTS lesion involving a bifurcation (defined as lesions involving side branches \\>2.0 mm).\n   5. Angiographic or CCTA evidence of severe calcification and\u002For marked tortuosity of the index vessel and\u002For lesion.\n   6. Thrombotic lesions.\n   7. Ostial lesions.",{"count":348,"type":21},30,[24],"ICECAP is a multi-centre, prospective, single-arm, interventional, traditional feasibility clinical investigation to evaluate the efficacy and safety of intra-coronary cryotherapy on vulnerable or high-risk plaque (HRP), using the CryoTherapy System (CTS). The study aims to enroll 25 patients with symptomatic coronary artery disease, successfully treated for their culprit lesion and with presence of at least one HRP lesion in another vessel. Eligible patients will undergo cryotherapy during a planned procedure. Near-infrared spectrometry (NIRS and Optical Coherence Tomography imaging will be used during baseline procedure, and during a 9 months follow visit. The primary endpoint is reduction of plaque burden measured as 30% reduction in maxLCBI4mm as measured by NIRS at 9 months post procedure.",[27,352,353,354,355,356,357],"Plaque","Vulnerable Plaque","Cryotherapy","Cryotherapy Effect","Coronary Balloon","Atherosclerosis Coronary Artery With Angina Pectoris",[359,360,361,362,363,364,365],"Medical device","traditional feasibility","Single Group","Device Feasibility","Multi-Center","Prospective","Interventional","2026-03-31",{"date":368,"type":37},"2026-04-06",{"date":370,"type":37},"2025-03-01",{"date":372,"type":21},"2027-06-30",{"name":374,"class":44},"Cryotherapeutics SA",3,{"id":377,"slug":378,"hasResults":12,"nctId":379,"briefTitle":380,"officialTitle":381,"acronym":382,"eligibilityCriteria":383,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":384,"enrollmentInfo":385,"targetDuration":4,"studyType":22,"phases":387,"briefSummary":388,"conditions":389,"keywords":390,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":394,"lastUpdatePostDateStruct":395,"startDateStruct":397,"completionDateStruct":399,"leadSponsor":400,"locationsCount":375},"100600153","super-high-pressure-balloon-versus-intravascular-lithotripsy-to-prepare-severely-calcified-coronary-lesions-100600153","NCT07093788","Super High-pressure Balloon Versus Intravascular Lithotripsy to Prepare Severely Calcified Coronary Lesions","Super High-pressure Balloon Versus Intravascular Lithotripsy to Prepare Severely Calcified Coronary Lesions: a Randomized Controlled Trial (Shape)","Shape","Inclusion Criteria:\n\n* Age \\> 18 years and \\\u003C 80 years\n* Presented as asymptomatic angina, stable angina, unstable angina, prior myocardial infarction (MI), or non-ST-elevation myocardial infarction (NSTEMI).\n* Have an indication for drug-eluting stent (DES) implantation\n* Denovo coronary artery calcified lesions\n* Target lesion diameter stenosis ≥ 70%, or target lesion diameter stenosis between ≥ 50% and \\\u003C 70%, accompanied by evidence of myocardial ischemia(such as fractional flow reserve (FFR) ≤ 0.80 or minimal lumen area (MLA) ≤ 4.0 mm²).\n* Reference vessel diameter of the target vessel between 2.5 mm - 4.5 mm\n* Maximum calcium arc within the lesion ≥ 270⁰ assessed by optical coherence tomography (OCT) or intravascular ultrasound (IVUS)\n* Unsatisfactory lesion preparation with non-compliant balloon, defined as baseline diameter stenosis reduction of \\\u003C 30% under maximal inflation pressure.\n* Provision of written informed consent\n\nExclusion Criteria:\n\n* Presented as acute ST-segment elevation myocardial infarction (STEMI), cardiogenic shock and multiple organ failure\n* Presented as severe contrast agent allergy\n* Intolerant to dual antiplatelet therapy (DAPT) and\u002For anticoagulation therapy\n* Presented as active phase of autoimmune disease\n* Calcified nodules or eccentric calcification lesions\n* Failure to reach the target lesion with guidewires or catheters\n* Complex coronary bifurcation lesions\n* Target vessel thrombosis or aneurysm within 10 mm of the target lesion","80 Years",{"count":386,"type":21},78,[24],"this trial aimed to evaluate the stent expansion through intravascular imaging (optical coherence tomography (OCT) \\& intravascular ultrasound (IVUS)) among individuals underwent different preparation techniques ,then comparing the efficacy and safety of super high-pressure balloon to IVL in severely calcified lesions",[149,27,94],[391,392,393],"super high-pressure balloon","percutaneous coronary intervention","intravascular lithotripsy","2026-03-06",{"date":396,"type":37},"2026-03-10",{"date":398,"type":37},"2025-09-01",{"date":372,"type":21},{"name":401,"class":77},"Nanjing First Hospital, Nanjing Medical University",{"id":403,"slug":404,"hasResults":12,"nctId":405,"briefTitle":406,"officialTitle":407,"acronym":408,"eligibilityCriteria":409,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":410,"enrollmentInfo":411,"targetDuration":412,"studyType":90,"phases":4,"briefSummary":413,"conditions":414,"keywords":417,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":424,"lastUpdatePostDateStruct":425,"startDateStruct":427,"completionDateStruct":429,"leadSponsor":431,"locationsCount":375},"100627153","validation-of-sudden-cardiac-arrest-risk-factors-in-patients-with-cad-100627153","NCT07444931","Validation of Sudden Cardiac Arrest Risk Factors in Patients With CAD","Validation of Sudden Cardiac Arrest Risk Factors in Patients With CAD - CVDLINK Clinical Validation Study.","SCAR","Inclusion Criteria:\n\n* Age ≥ 18 years old\n* Ability to give informed consent\n* Imaging confirmed diagnosis within the past 12 months (coronary artery angiography or contrast enhanced coronary computed tomography)\n\n  •\\>50% of stenosis and\u002For fractional flow-reserve \\\u003C0.8 verified by selective coronary angiography or by contrast enhanced coronary computed tomography (CT) or type I MI with atherosclerotic origin (despite stenosis percentage)\n* Patients may be recruited during index event visit (out-patient clinic visit, invasive procedure, hospitalization) (or if logistically possible recall patients previously diagnosed within 12 months)\n\nExclusion Criteria:\n\n* Age \\> 75 years of age\n* Clinically significant previously treated valvular heart disease or requiring operative (surgical or endovascular) treatment within following three months\n* Diagnosed severe neurodegenerative disease (ALS, myositis, multiple sclerosis, or Parkinson's disease) or known impaired cognitive function (MMSE \\\u003C23)\n* Known developmental disability impairing legal ability to give written consent\n* Serious\u002Factive malignancy with possibly reduced life expectancy of \\\u003C1 year (estimated by a physician)\n* Inability to give written consent for some other reason\n* Other significant cardiac condition severely linked to the risk of fatal ventricular arrhythmia (for example ARVCD, non-ischemic DCM, HCM or genetic long or short QT syndrome)\n* Other cardiac disease with \\\u003C1 years of life expectancy\n* Do-Not-Resuscitate (DNR) order made due to any reason\n* Previously done or planned cardiac, renal, or liver transplant\n* Participation in another clinical trial where the active treatment","75 Years",{"count":136,"type":21},"1 Year","Long-term sudden cardiac death (abbreviation: SCAR) focuses on improving the predictability of sudden cardiac death (SCD) in patients diagnosed with coronary artery disease. The aim of the study is to determine the predictive value of measurable biological variables (including genetic factors, cardiac electrical activity, biological markers measured from circulation, and coronary artery anatomy) as well as the patients' psychosocial factors in predicting SCDs.\n\nThe purpose of this study is the identification of a subgroup of coronary artery disease patients at sufficiently high risk in whom it may be possible to prevent sudden cardiac arrests and subsequent deaths using implantable cardioverter-defibrillators. The study is intended to establish a clear foundation for future interventional studies targeting high-risk coronary artery disease patients.\n\nThe primary endpoint of the study is SCD\u002Fsudden cardiac arrest (SCA) or a comparable malignant arrhythmic event (i.e., resuscitation). Secondary endpoints include other major cardiovascular events occurring during the follow-up period (such as cerebrovascular events, myocardial infarctions, revascularizations, and new arrhythmias like atrial fibrillation following procedures or after the patient has been discharged following recruitment) or the occurrence and mortality of other significant life-threatening diseases (such as cancer). Secondary endpoints also include poor success in secondary prevention, which can be assessed through completed medication purchases and the achievement of secondary prevention goals.\n\nThis observational, prospective study includes collecting multimodal data from hospitals in Finland (TAUH), Israel (HYMC), Moldova (IMSP) and Romania (UMFCD). Each participating institution has followed a process structured by Tampere Heart Hospital (TAUH) for securing permissions in line with EU and national regulations.",[27,415,416],"Sudden Cardiac Arrest","Sudden Cardiac Death",[418,419,420,421,422,423],"Coronary artery disease","Sudden cardiac arrest","Sudden cardiac death","post operative atrial fibrillation","genetics","risk factors","2026-03-02",{"date":426,"type":37},"2026-03-03",{"date":428,"type":37},"2025-01-05",{"date":430,"type":21},"2027-12-31",{"name":432,"class":77},"Tampere Heart Hospital",{"id":434,"slug":435,"hasResults":12,"nctId":436,"briefTitle":437,"officialTitle":438,"acronym":439,"eligibilityCriteria":440,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":441,"targetDuration":4,"studyType":90,"phases":4,"briefSummary":443,"conditions":444,"keywords":449,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":424,"lastUpdatePostDateStruct":455,"startDateStruct":456,"completionDateStruct":458,"leadSponsor":460,"locationsCount":159},"100627155","safety-and-effectiveness-of-the-crystalline-sirolimus-eluting-device-in-patients-with-coronary-artery-disease-100627155","NCT07444957","Safety and Effectiveness of the Crystalline Sirolimus-Eluting Device in Patients With Coronary Artery Disease","Safety and Effectiveness of the Crystalline Sirolimus-Eluting Device (SeQuent® Sirolimus-Coated Balloon) in Patients With Coronary Artery Disease: A Prospective Observational Study","SECuRE","Inclusion Criteria:\n\n* All patients must provide written informed consent.\n* Patients aged ≥18 years with coronary artery disease in whom, at the operator's discretion, treatment of a coronary stenosis in a native vessel (either de novo lesion or in-stent restenosis) or in a coronary bypass graft using the cSCB is indicated, in accordance with routine clinical practice.\n* All treated lesions\u002Fsegments (single or tandem) must receive cSCB therapy covering at least 3 mm beyond both edges of the lesion or pre-dilated segment to avoid geographic miss.\n* In patients with multivessel coronary artery disease, all non-target vessels will be treated according to operator discretion: a) If more than one vessel is treated with the investigational device (SeQuent® SCB), all vessels will be documented and analyzed separately. b) Only one lesion per vessel will be included unless lesions are separated by ≥20 mm. c) Only one lesion per vessel will be included. d) If more than one lesion in the target vessel requires treatment, all lesions treated with a device different from the investigational procedure or with a device other than the investigational device (SeQuent® SCB) must be separated from the target lesion by ≥20 mm or considered as a single treated lesion according to this study protocol.\n\nExclusion Criteria:\n\n* Explicit refusal by the patient to participate in the study.\n* Known intolerance to sirolimus or to any component of the investigational device.\n* Contraindication to any antiplatelet therapy.\n* Life expectancy less than 12 months.\n* Indication for surgical coronary revascularization.\n* Pregnancy or breastfeeding.\n* Clinical characteristics considered unsuitable for drug-coated balloon use at the operator's discretion, including: a) Hemorrhagic diathesis or other conditions such as gastrointestinal ulceration or cerebrovascular disorders restricting the use of antiplatelet therapy. b) Cardiogenic shock. c) Patients with left ventricular ejection fraction \\\u003C30% without the use of a ventricular assist device during PCI.\n\nAngiographic exclusion criteria\n\n* Reference vessel diameter \\\u003C2.00 mm or \\>4.0 mm.\n* Treatment of the left main coronary artery.\n* Lesions not amenable to PCI or other interventional techniques.\n* Coronary artery spasm in the absence of significant stenosis.\n* Target lesion not suitable for drug-coated balloon-only PCI at the operator's discretion, including: a) Aorto-ostial lesions. b) Lesions with significant persistent residual thrombotic content visible in the vessel despite thromboaspiration. c) Treatment shortly after myocardial infarction with evidence of thrombus or impaired coronary flow.",{"count":442,"type":21},1118,"This prospective, multicenter, post-market observational study aims to evaluate the safety and effectiveness of the crystalline sirolimus-coated balloon (SeQuent® Sirolimus-Coated Balloon) for the treatment of coronary artery disease in routine clinical practice. Consecutive, unselected adult patients undergoing percutaneous coronary intervention for de novo coronary lesions or in-stent restenosis will be enrolled.\n\nThe primary objective is to assess target lesion failure at 12 months, defined as the composite of target vessel myocardial infarction or ischemia-driven target lesion revascularization. Secondary objectives include angiographic procedural success, major adverse cardiovascular events, bleeding outcomes, and longer-term clinical results up to 36 months, as well as outcomes across predefined anatomical and clinical subgroups.\n\nThe study seeks to answer whether treatment with the crystalline sirolimus-coated balloon provides a safe and effective revascularization strategy in a real-world population with diverse clinical presentations and lesion characteristics.",[27,445,446,30,447,448],"NSTEMI - Non-ST Segment Elevation Myocardial Infarction (MI)","Stable Angina, Unstable Angina, NSTEMI","ST-Elevation Myocardial Infarction","Silent Ischemia",[450,451,452,453,454],"coronary arterial disease","drug coated ballloon","TLR","TVR","MACE",{"date":426,"type":37},{"date":457,"type":37},"2026-01-05",{"date":459,"type":21},"2030-07-06",{"name":461,"class":77},"Fundación Interhospitalaria para la Investigación Cardiovascular FIC",{"id":463,"slug":464,"hasResults":12,"nctId":465,"briefTitle":466,"officialTitle":467,"acronym":468,"eligibilityCriteria":469,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":470,"targetDuration":4,"studyType":22,"phases":471,"briefSummary":472,"conditions":473,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":424,"lastUpdatePostDateStruct":474,"startDateStruct":476,"completionDateStruct":478,"leadSponsor":480,"locationsCount":159},"100586526","phase-4-prasugrel-monotherapy-reduced-dose-in-acute-and-chronic-coronary-syndrome-patients-after-percutaneous-coronary-intervention-promote-100586526","NCT06916520","Prasugrel Monotherapy Reduced Dose in Acute and Chronic Coronary Syndrome Patients After Percutaneous Coronary Intervention (PROMOTE)","Prasugrel Monotherapy Reduced Dose in Acute and Chronic Coronary Syndrome Patients After Percutaneous Coronary Intervention","PROMOTE","Inclusion Criteria:\n\n* Acute Coronary Syndrome\n* Chronic Coronary Syndrome\n* Successful PCI\n\nExclusion Criteria:\n\n* Known allergy or contraindication for prasugrel, including Active pathological bleeding Severe liver disease (defined as Child Pugh class C)\n* Current indication for oral anticoagulant therapy (OAC)\n* Indication for ongoing DAPT (e.g. PCI ≤ 6 months for CCS or ACS ≤ 12 months)\n* Pregnancy or breast-feeding women\n* Participation in another trial with an investigational drug or device\n* Recent or ongoing use of CYP2B6 substrates with a narrow therapeutic window (e.g. cyclophosphamide, efavirenz)",{"count":88,"type":21},[216],"Rationale: Dual antiplatelet therapy, consisting of aspirin and a P2Y12-inhibitor, reduces the risk of stent-related and non-stent-related ischemic events after percutaneous coronary intervention (PCI). However, this therapy is also associated with a higher risk of bleeding. Given the advances in stent technology and pharmacology, it may be possible to treat patients undergoing PCI with low dose prasugrel as single antiplatelet therapy, regardless of medical history, age or body weight.\n\nObjective: Assess the feasibility and safety of a single antiplatelet strategy with a reduced dose of prasugrel 5 mg after PCI in acute and chronic coronary syndrome patients (ACS and CCS).\n\nStudy design: Open-label, single-centre, randomized controlled trial.\n\nStudy population: Patients undergoing successful PCI due to acute or chronic coronary syndrome.\n\nIntervention: A once-daily reduced dose of 5 mg prasugrel for 6 months in CCS patients and for 12 months in ACS patients, preceded by a loading dose of 60 mg prasugrel after PCI, administered without concomitant use of aspirin.\n\nMain study parameters\u002Fendpoints: The primary endpoint is Net Adverse Clinical Events (NACE), a composite of all-cause death, myocardial infarction, definite stent thrombosis, ischemic stroke, clinically relevant non-major bleeding or major bleeding defined as Bleeding Academic Research Consortium type 2, 3 or 5.",[27,172],{"date":475,"type":37},"2026-03-04",{"date":477,"type":37},"2025-11-13",{"date":479,"type":21},"2027-04",{"name":481,"class":77},"J.P.S Henriques",{"id":483,"slug":484,"hasResults":12,"nctId":485,"briefTitle":486,"officialTitle":487,"acronym":488,"eligibilityCriteria":489,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":490,"targetDuration":4,"studyType":22,"phases":492,"briefSummary":493,"conditions":494,"keywords":495,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":501,"lastUpdatePostDateStruct":502,"startDateStruct":504,"completionDateStruct":506,"leadSponsor":508,"locationsCount":159},"100561317","phase-4-the-switching-antiplatelet-9-swap-9-study-100561317","NCT06588595","The Switching Antiplatelet-9 (SWAP-9) Study","Comparison of ABCD-GENE Score-Guided Versus Unguided DAPT De-Escalation: A Prospective Randomized Pharmacodynamic Study in Patients Undergoing PCI The Switching Antiplatelet-9 (SWAP-9) Study","SWAP-9","Inclusion Criteria:\n\n1. Patients who have undergone PCI and are on maintenance treatment with DAPT, composed of low-dose aspirin (81mg qd) with either prasugrel (10 mg qd) or ticagrelor (90 mg bid). In particular, patients who underwent PCI in the setting of an acute coronary syndrome will be eligible for randomization after ≥90 days post-PCI, while patients who underwent PCI in the setting of a chronic coronary syndrome ≥30 days post-PCI.\n2. Age ≥18 years\n3. Provide written informed consent.\n\nExclusion Criteria:\n\n1. Prior history of stent thrombosis\n2. PCI within 30 days\n3. On treatment with any oral anticoagulant (vitamin K antagonists, dabigatran, rivaroxaban, apixaban, edoxaban) or chronic low-molecular-weight heparin (at venous thrombosis treatment, not for prophylaxis)\n4. Hemodynamic instability\n5. Hypersensitivity to clopidogrel\n6. Known platelet count less than 80x10\\^6\u002FmL\n7. Known hemoglobin less than 9 g\u002FdL\n8. Pregnant and breastfeeding women \\[women of childbearing age must use reliable birth control (i.e., oral contraceptives) while participating in the study\\].",{"count":491,"type":21},90,[216],"The purpose of this study is to compare the pharmacodynamic effects of ABCD-GENE guided vs. unguided de-escalation strategies among patients on dual antiplatelet therapy (DAPT) following percutaneous coronary intervention (PCI).",[27],[496,497,498,499,500],"ABCD-GENE score","Dual antiplatelet therapy (DAPT)","Pharmacodynamic (PD) study","Percutaneous coronary intervention (PCI)","P2Y12 receptor inhibitor","2026-02-24",{"date":503,"type":37},"2026-02-25",{"date":505,"type":37},"2024-11-01",{"date":507,"type":21},"2027-02-28",{"name":231,"class":77},{"id":510,"slug":511,"hasResults":12,"nctId":512,"briefTitle":513,"officialTitle":514,"acronym":4,"eligibilityCriteria":515,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":516,"enrollmentInfo":517,"targetDuration":4,"studyType":22,"phases":519,"briefSummary":520,"conditions":521,"keywords":524,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":527,"lastUpdatePostDateStruct":528,"startDateStruct":530,"completionDateStruct":532,"leadSponsor":534,"locationsCount":204},"100624298","feasibility-study-of-the-supira-system-in-patients-undergoing-hrpci-with-support-beyond-the-pci-procedure-100624298","NCT07407816","Feasibility Study of the Supira System in Patients Undergoing HRPCI With Support Beyond the PCI Procedure","Feasibility Study of the Supira System in Patients Undergoing High-Risk Percutaneous Coronary Intervention (HRPCI) Who May Benefit From Mechanical Circulatory Support Beyond the PCI Procedure","Inclusion Criteria:\n\n* Subject has pre-existing heart failure, with NYHA Class II, III or IV prior to the index admission and documented LVEF ≤ 45%\n* Subject is presenting with one of the following criteria: unprotected left main coronary artery (ULMCA) disease, last patent vessel, or 3-vessel disease\n* Subject may benefit from hemodynamic support beyond the index procedure\n* Informed consent granted by the patient or legally authorized representative\n\nExclusion Criteria:\n\n* Stroke within 6 months of the index procedure, or any prior stroke with permanent neurologic deficit\n* Aortic valvular disease or regurgitation categorized as moderate or greater (≥2+ on a 4-grade scale as assessed on TTE)\n* Aortic stenosis and\u002For aortic regurgitation categorized as moderate or greater (mean gradient \\>20 mmHg or valve area \\\u003C1.5 cm2 as assessed on TTE)\n* Presence of decompensated liver disease; severe liver dysfunction (Child-Pugh Score class C)\n* Ongoing renal replacement therapy with dialysis or continues renal replacement therapy\n* Heparin-induced thrombocytopenia, current or any prior occurrences\n* Known hypersensitivity to intravenous contrast agents that cannot be adequately pre-medicated or known hypersensitivity to heparin, aspirin, adenosine diphosphate (ADP) receptor inhibitors, or nitinol\n* Known or suspected coagulopathy or abnormal coagulation parameters (defined as platelet count ≤ 100,000\u002Fmm³ or spontaneous International Normalized Ratio (INR) ≥1.5 in the absence of medication or known fibrinogen ≤1.5 g\u002FL)\n* Breastfeeding or pregnant\n* Currently participating in active follow-up phase of another clinical study of an investigational drug or device\n* Other medical, social, or psychological problems that, in the opinion of the Investigator, compromises the subject's ability to provide written informed consent and\u002For to comply with study procedures","90 Years",{"count":518,"type":21},45,[24],"The objective of this study is to assess the safety and feasibility of the Supira System in heart failure patients with low LVEF, undergoing HRPCI with use of mechanical circulatory support who may benefit from cardiovascular hemodynamic support beyond the PCI procedure.",[522,27,523],"Heart Disease","Heart Failure",[525,526],"Percutanous ventricular assist device","Supira System","2026-02-11",{"date":529,"type":37},"2026-02-17",{"date":531,"type":37},"2025-10-12",{"date":533,"type":21},"2027-05",{"name":535,"class":44},"Supira Medical",{"id":537,"slug":538,"hasResults":12,"nctId":539,"briefTitle":540,"officialTitle":541,"acronym":542,"eligibilityCriteria":543,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":544,"targetDuration":4,"studyType":22,"phases":546,"briefSummary":548,"conditions":549,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":554,"lastUpdatePostDateStruct":555,"startDateStruct":557,"completionDateStruct":559,"leadSponsor":561,"locationsCount":563},"100587388","phase-2-focused-orticumab-research-for-treating-inflammation-in-coronary-arteries-100587388","NCT06927739","Focused Orticumab Research for Treating Inflammation in Coronary Arteries","A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of Orticumab in Participants With Prior Myocardial Infarction Who Have Elevated Coronary Inflammation Based on FAI Score Assessed by CCTA","FORTIFY","Inclusion Criteria:\n\n1. Participant must provide informed consent before any study specific activities are performed, must be able and willing to meet all requirements for randomization and must adhere to the schedules of activities.\n2. Participant must be \\>180 days after presumed type-1 myocardial infarction (i.e., due to plaque rupture or erosion, either STEMI or NSTEMI) without subsequent unstable or severe angina (Canadian Cardiovascular Society Class 3 or 4) at the time of enrollment. Participants who have undergone PCI are allowed.\n3. Participant must be on a stable cardiovascular treatment regimen consistent with local treatment guidelines for post-AMI patients (such as maximally tolerated statin and\u002For PCSK9 inhibitor medication for LDL reduction, antiplatelet medication, and hypertension treatment).\n4. Participant must have an evaluable, pre-randomization CCTA with one of the following:\n\n   1. A quantifiable Fat Attenuation Index (FAI) Score greater than or equal to the 50th centile (per reference standard) for their age group in at least two coronary arteries or\n   2. A quantifiable Fat Attenuation Index (FAI) Score greater than or equal to the 75th centile (per reference standard) for their age group in at least one coronary artery\n5. Participant must have body mass index (BMI) ≤ 40 kg\u002Fm2.\n6. Adult male and female participants ≥18 years of age at the Screening Visit:\n\nFor female participants, the participant must not be pregnant or lactating and must be one of the following:\n\n1. Postmenopausal, defined as amenorrhea for ≥ 12 months following cessation of all exogenous hormonal treatments; follicle stimulating hormone levels may be obtained at the investigator's discretion to confirm the participant is postmenopausal.\n2. Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy. Tubal ligation is not considered as irreversible surgical sterilization.\n3. Females of childbearing potential must have a negative serum or urine pregnancy test prior to the start of study drug. In the case of positive urine pregnancy testing, a negative serum sample for pregnancy testing, to confirm that the participant is not pregnant, must be obtained prior to start of study. They must also agree to use an adequate method of contraception from Baseline through the End of the study or for 30 days after the last dose of study drug (whichever is longer), which include the following: sexual abstinence (if preferred and usual lifestyle of the participant), condom with spermicidal gel, diaphragm with spermicidal gel, coil (intrauterine device), surgical sterilization, vasectomy, oral contraceptive pill, depo progesterone injections, progesterone implant (i.e., Implanon®), NuvaRing®, Ortho Evra®.\n\nFor male participants - Nonsterile male participants with sexual partners of childbearing potential must agree to use an adequate method of contraception, including sexual abstinence (if preferred and usual lifestyle of the participant), from Baseline through the End of the study.\n\nExclusion Criteria:\n\n1. History of any clinically important disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study.\n2. Percutaneous coronary intervention or invasive diagnostic coronary angiogram planned after screening. Eligible participants who have an invasive diagnostic coronary angiogram performed in the absence of undergoing a new PCI may continue screening after the diagnostic angiogram has been performed or may be rescreened.\n3. History of or planned coronary artery bypass grafting.\n4. Documented episode of post-MI pericarditis in the 3 months before enrollment.\n5. Presence of unstable or uncontrolled angina. Canadian CV society (CCS) angina class \\> 2.\n6. Ongoing New York Heart Association Class IV HF.\n7. Poorly controlled type 1 or type 2 diabetes mellitus (hemoglobin A1c \\>8.0%).\n8. Increased risk of bleeding:\n\n   1. With history or presence of any bleeding disorder.\n   2. Signs of ongoing bleeding at screening (e.g., identified macroscopic bleeding, low hemoglobin presumed to be caused by bleeding) or high risk for major bleeding in accordance with the Investigator's assessment (participants taking clinically indicated antiplatelet and antithrombotic agents are acceptable).\n   3. Known severe liver disease (e.g., \\>5´ upper limit of normal elevations in ALT and\u002For AST and other evidence of grade 3 or higher criteria applies such as from the CTCAE 5.0 guidelines).\n9. History or presence of any of the following:\n\n   1. Ongoing infection or febrile illness.\n   2. Ongoing persistent or permanent atrial fibrillation or flutter.\n   3. Cancer within 5 years before randomization, with the exception of non-melanoma skin cancer.\n   4. Alcohol or substance abuse within 6 months before randomization, as judged by the investigator.\n   5. Known history of hypersensitivity reactions to other biologics, to human IgG preparations, or to any component of orticumab, or ongoing severe allergy as judged by the investigator.\n   6. Active positive results on screening for serum hepatitis C core antibody.\n   7. Clinically documented hepatitis B or HIV.\n10. Any clinically important abnormalities in clinical chemistry, hematology, coagulation parameters, as judged by the investigator.\n11. Blood pressure values at screening (taken as the average of triplicate measurements):\n\n    1. Systolic blood pressure \\\u003C 90 mmHg or \\> 180 mmHg.\n    2. Diastolic blood pressure \\> 100 mmHg.\n    3. One triplicate retest (repeat of all 3) will be allowed during the same visit, at which point if the retest result is no longer exclusionary, the participant may be randomized\n    4. Participants who are excluded based on elevated blood pressure may be rescreened following adequate treatment.\n12. Participants with any of the following contraindications to CCTA.\n\n    1. eGFR \\\u003C 40 mL\u002Fmin\u002F1.73 m2 by the Chronic Kidney Disease Epidemiology Collaboration equation, or end stage renal disease treated with kidney transplant or renal replacement therapy.\n    2. Allergy to iodinated contrast.\n    3. History of contrast-induced nephropathy.\n    4. Contraindication to nitroglycerin.\n    5. Rapid heart rate that is uncontrolled by medical therapy.\n    6. Inability to hold breath for at least 6 seconds.\n13. Use of any of the following in the 180 days before randomization: IL-17 inhibitor, TNF inhibitor, IL-6 inhibitor, IL-1β inhibitor, methotrexate, cyclosporine, apremilast, colchicine, systemic steroids (topical steroid use is allowed).\n14. COVID-19 vaccine within 90 days of screening CCTA.\n15. Participants with a confirmed positive COVID-19 test within 90 days of screening CCTA.\n16. Receipt of any investigational device or therapy within 6 months or 5 half-lives before screening (whichever is longer).\n17. Planned participation in an additional investigational study of an intervention or biologic before the end of the follow-up period. Participation in observational studies or studies without investigational drugs or devices is allowed.\n18. Participants who have previously been exposed to orticumab.\n19. Participants who are legally institutionalized.\n20. An employee or close relative of an employee of the sponsor, the CRO, or the study site, regardless of the employee or close relative's role.",{"count":545,"type":21},240,[547],"PHASE2","The goal of this clinical trial is to determine the clinical effect of orticumab treatment on inflammation in study participants with prior myocardial infarction who have elevated coronary inflammation based on CCTA. The main question it aims to answer is:\n\nClinical effects of orticumab treatment on inflammation of the coronary artery parameters measured with CCTA\n\nResearchers will compare the effects with placebo group after 6 months of treatment\n\nParticipants will Keep the planned study visit appointments Provide complete information about medical and medical history Speak to the study doctor before changing any of non-study treatments, including starting new medications, receiving any vaccinations, or setting out to join any other clinical studies",[550,27,551,522,552,553],"Acute Coronary Syndromes","Inflammation","Myocardial Infarct","Atherosclerotic Coronary Vascular Disease","2026-01-24",{"date":556,"type":37},"2026-01-27",{"date":558,"type":37},"2025-08-11",{"date":560,"type":21},"2027-06-01",{"name":562,"class":44},"Abcentra",41,{"id":565,"slug":566,"hasResults":12,"nctId":567,"briefTitle":568,"officialTitle":569,"acronym":570,"eligibilityCriteria":571,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":572,"targetDuration":412,"studyType":90,"phases":4,"briefSummary":573,"conditions":574,"keywords":575,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":580,"lastUpdatePostDateStruct":581,"startDateStruct":583,"completionDateStruct":585,"leadSponsor":587,"locationsCount":589},"100586455","drug-coated-coronary-balloons-in-different-clinical-scenarios-100586455","NCT06915597","Drug-Coated Coronary Balloons in Different Clinical Scenarios","Procedural Success and Short- and Long-Term Outcomes of Drug-Coated Coronary Balloons Used in Different Clinical Scenarios","DCB-DCS","Inclusion Criteria:\n\nAge ≥18 years. Patients with coronary artery disease undergoing percutaneous coronary intervention (PCI) in whom a drug-coated balloon (DCB) is used as the intended treatment strategy for at least one target lesion.\n\nDCB use in any clinical presentation, including stable coronary artery disease and acute coronary syndromes.\n\nDCB treatment for different lesion subsets, including de novo lesions, in-stent restenosis, bifurcation lesions, small and large vessels, and chronic total occlusions.\n\nSuccessful lesion preparation allowing DCB angioplasty (residual stenosis ≤30% and absence of flow-limiting dissection before DCB inflation, according to operator judgment).\n\nAvailability of baseline clinical, angiographic, and procedural data. Ability to provide informed consent for prospective enrollment or availability of data according to local regulations for retrospective inclusion.\n\nPlanned clinical follow-up.\n\nExclusion Criteria:\n\nPrimary treatment strategy without the use of a drug-coated balloon (e.g., exclusive drug-eluting stent implantation without DCB).\n\nCardiogenic shock at the time of index procedure. Life expectancy less than 1 year due to non-cardiac comorbidities. Contraindication to antiplatelet therapy. Known severe allergy to contrast media not amenable to premedication. Pregnancy. Inability to comply with clinical follow-up. Participation in another interventional clinical trial that could confound outcome assessment.",{"count":136,"type":21},"Coronary stents are the best treatment method ever accepted in the treatment of coronary artery stenoses. Due to some limitations and complications of stent use, the operators tried to find new solutions. Drug Coated Balloons (DCBs) have been accepted as a new method in the treatment of in-stent restenosis and small vessel disease. Furthermore, they have been used in the treatment of de novo coronary lesions, chronic total occlusions and bifucation lesions. But data is limited in the short and long term success of DCBs in all these clinical scenarios. In our study we aimed to investigate the procedural success and short and long term outcomes of DCB use in different clinical scenarios.",[27],[576,220,577,578,579],"drug coted balloons","chronic total occlusions","de novo lesions","small vessel disease","2026-01-11",{"date":582,"type":37},"2026-01-13",{"date":584,"type":37},"2025-05-31",{"date":586,"type":21},"2026-05-31",{"name":588,"class":77},"Kutahya Health Sciences University",5,{"id":591,"slug":592,"hasResults":12,"nctId":593,"briefTitle":594,"officialTitle":595,"acronym":596,"eligibilityCriteria":597,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":598,"targetDuration":4,"studyType":22,"phases":600,"briefSummary":601,"conditions":602,"keywords":603,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":610,"lastUpdatePostDateStruct":611,"startDateStruct":613,"completionDateStruct":615,"leadSponsor":617,"locationsCount":159},"100598229","shockwave-intervention-for-enhanced-wound-healing-in-no-touch-pedicle-saphenous-vein-graft-harvesting-for-coronary-artery-bypass-grafting-100598229","NCT07068776","Shockwave Intervention for Enhanced Wound Healing in No-touch Pedicle Saphenous Vein Graft Harvesting for Coronary Artery Bypass Grafting","Shockwave Intervention for Enhanced Wound Healing in No-touch Pedicle Saphenous Vein Graft Harvesting for Coronary Artery Bypass Grafting: A Prospective, Single-Center, Single-Blind, Randomized, Sham-Controlled Study","SHIELDS-CABG","Inclusion Criteria:\n\n* Male or female patients \\> 18 years\n* Isolated CABG procedure in the need of 2 or more venous grafts\n* Elective or urgent cases\n* Median sternotomy approach\n* eGFR ≥ 15 ml\u002Fmin\n* Willing to participate in trial\n* Able to provide informed consent\n\nExclusion Criteria:\n\n* History of venous stripping or ligation\n* Uncontrolled Diabetes mellitus (HbA1c ≥ 9 %)\n* Enrolled in other therapeutic or interventional trial\n* Hemodynamically unstable\n* Cardiogenic shock\n* Any condition that seriously increases the risk of noncompliance or loss of follow-up\n* Emergency case\n* Salvage case",{"count":599,"type":21},120,[24],"The aim of this trial is to apply shockwaves to the leg wound after saphenous vein harvesting and closure in order to reduce the occurrence of postoperative wound healing complications following coronary artery bypass grafting using venous grafts.",[27],[604,605,606,607,608,609],"Coronary artery bypass grafting","Saphenous vein graft (SVG)","No-touch vein harvesting","Wound healing complications","Shockwave therapy (SWT)","Cardiac surgery","2025-12-21",{"date":612,"type":37},"2025-12-23",{"date":614,"type":37},"2025-10-03",{"date":616,"type":21},"2029-01",{"name":618,"class":77},"Medical University Innsbruck",{"id":620,"slug":621,"hasResults":12,"nctId":622,"briefTitle":623,"officialTitle":623,"acronym":4,"eligibilityCriteria":624,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":625,"targetDuration":412,"studyType":90,"phases":4,"briefSummary":627,"conditions":628,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":629,"lastUpdatePostDateStruct":630,"startDateStruct":632,"completionDateStruct":634,"leadSponsor":636,"locationsCount":4},"100615673","external-validation-of-ischemia-and-hemorrhage-risk-models-in-patients-with-coronary-heart-disease-100615673","NCT07295665","External Validation of Ischemia and Hemorrhage Risk Models in Patients With Coronary Heart Disease","Inclusion Criteria:\n\n* Age ≥ 18 years old;\n* Patients with clinically diagnosed various types of coronary heart disease, who are scheduled to receive long-term antithrombotic treatment;\n* Patients with acute coronary syndrome or those who have undergone coronary intervention therapy, whose condition must be stable after treatment and meet the discharge criterias;\n\nExclusion Criteria:\n\n* Combination of severe non-cardiovascular diseases: Expected lifespan does not exceed 6 months, such as patients with advanced cancer or other terminal diseases;\n* Unable to cooperate with long-term follow-up: Such as patients with severe cognitive impairment or severe mental illness;\n* Non-cardiovascular death within 24 hours after admission.",{"count":626,"type":21},5000,"Thrombosis formation is the core mechanism for the occurrence of major adverse cardiovascular and cerebrovascular events in patients with coronary heart disease. Antithrombotic therapy is one of the most important treatment methods for secondary prevention of coronary heart disease. Antithrombotic drugs, while reducing ischemic events, often significantly increase the risk of bleeding. How to balance the risk of recurrent ischemic events and bleeding events in patients with coronary heart disease is a major challenge in the treatment of coronary heart disease. This project establishes a high-quality multicenter, prospective coronary heart disease cohort, with patients covering various clinical characteristics such as different regions, ages, and comorbidities. It verifies the ischemic risk and bleeding risk model developed in Project 1, compares the efficacy improvement of the new model with the traditional risk model, and verifies the effectiveness and stability of the model in different subgroups of the population, and assesses the generalizability of the model in real-world clinical practice, providing high-quality evidence-based basis for the formulation of individualized and precise antithrombotic strategies for coronary heart disease.",[27],"2025-12-16",{"date":631,"type":37},"2025-12-19",{"date":633,"type":21},"2026-01-01",{"date":635,"type":21},"2029-07-31",{"name":637,"class":638},"Beijing Hospital","OTHER_GOV",{"id":640,"slug":641,"hasResults":12,"nctId":642,"briefTitle":643,"officialTitle":643,"acronym":644,"eligibilityCriteria":645,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":646,"targetDuration":4,"studyType":22,"phases":647,"briefSummary":648,"conditions":649,"keywords":653,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":658,"lastUpdatePostDateStruct":659,"startDateStruct":661,"completionDateStruct":663,"leadSponsor":665,"locationsCount":159},"100616271","randomised-trial-of-dual-device-treatment-involving-drug-coated-balloon-angioplasty-and-drug-eluting-stent-implantation-compared-to-single-device-treatments-in-patients-with-diabetes-mellitus-100616271","NCT07303439","Randomised Trial of Dual Device Treatment Involving Drug-coated Balloon Angioplasty and Drug-eluting Stent Implantation Compared to Single Device Treatments in Patients With Diabetes Mellitus","DUBSTENT-DM","Inclusion Criteria:\n\n1. Patients with acute or chronic coronary syndrome\n2. Diagnosis of diabetes\n3. Patients undergoing PCI for de novo lesions in native coronary arteries\n4. Patients able and willing to provide written informed consent\n5. Age ≥ 18 years.\n6. Patients able and willing to comply with the study procedures and follow-up.\n7. All angiographic inclusion criteria fulfilled:\n\n   1. the lesion has been deemed treatable\n   2. the guidewire has crossed the lesion\n   3. the lesion has been successfully pre-dilated, where balloon expansion is complete, residual stenosis is less than 50% and thrombolysis in myocardial infarction (TIMI) flow is \\>2, and there is no evidence of flow-limiting dissection is seen.\n\nExclusion Criteria:\n\n1. Lesions located at the left main coronary artery.\n2. Patient presents with a ST-elevation myocardial infarction (STEMI).\n3. Patient with acute cardiac decompensation or acute cardiogenic shock.\n4. Patient with impaired renal function (glomerular filtration rate \\\u003C 30 mL\u002Fmin\u002F1.73 m2).\n5. Severe in-stent calcification that prevents a sufficient expansion of the DCB, unless adequately pre-treated, e.g. with super (high) pressure balloon, rotablation or lithotripsy.\n6. Evidence of high-grade dissection (National Heart, Lung, and Blood Institute (NHLBI) class C or greater) at baseline\n7. Known hypersensitivity or contraindication to sirolimus, paclitaxel, heparin, aspirin, thienopyridines, or iodinated contrast that cannot be pre-treated.\n8. Patients unable to take dual antiplatelet therapy for 6-12 months\n9. Pregnant and\u002For breast-feeding females or females who intend to become pregnant during the time of the study.\n10. Subject currently enrolled in other investigational device or drug trial in which the primary endpoint has not yet been reached.\n11. Anticipated difficulties to complete the angiographic surveillance.\n12. Patient with a life expectancy of less than 12 months.\n13. Patients lacking mental capacity (i.e. patients suffering from dementia and others) to provide informed consent.\n14. The study will not recruit participants who, in the opinion of the investigator, do not have an adequate understanding of English. Only participants who can fully comprehend the implications of participating in the study will be recruited",{"count":599,"type":21},[24],"Purpose of this study:\n\nThe purpose of the study is to find out whether using a drug coated balloon in combination with a drug-eluting stent is better than the standard practice of using either device on its own. This study is specifically looking at patients with diabetes who have coronary artery disease. This means that their arteries become restricted or blocked, and these restrictions or blockages are called lesions. The study will look at diabetic patients undergoing treatment for lesions in segments of their coronary arteries that have not previously been treated with stents. These are called 'de novo' lesions.\n\nThe treatment being investigated:\n\nIn this study, we are comparing two devices, either used together or on their own to treat coronary artery disease. These devices are commercially available in Europe and carry the mark. This study is being carried out to compare the effectiveness of combining the two devices or using them individually:\n\n* Pantera® Lux® Paclitaxel Drug Coated Balloon, abbreviated Pantera® Lux® (DCB) A drug coated balloon is a balloon which is covered by an anti-proliferative drug.\n* Orsiro® biodegradable polymer Sirolimus Eluting Stent Orsiro® (DES) A stent is a short, wire mesh tube that acts like a scaffold to keep your artery open. A drug eluting stent is coated with medication that reduces the risk of the artery becoming blocked again.\n\nBoth drug-eluting stents and drug-coated balloons are used routinely for the treatment of 'de novo' coronary artery disease in Europe.\n\nHow will the study be carried out?\n\nThis study is being conducted in 4 hospitals across Ireland. We aim to recruit 120 participants s in this study. If you agree to participate in this study and sign the informed consent form, you will be asked to participate in the screening process, which will determine if you meet the conditions to participate in the study.\n\nYou will be \"randomised\" into one of the 3 study groups. Randomisation means that you are put into a group by chance (similarly to the roll of a dice). Neither you nor your doctor can choose the group you will be in. You will not know which group you were placed in until the end of the study. However, your doctor will know which study group you were placed in.\n\n* 40 patients will be treated with Pantera® Lux® (Drug Coated Balloon) only\n* 40 patients will be treated with Orsiro® (Drug Eluting Stent) only\n* 40 patients will be treated with a combination of both Pantera® Lux® (Drug Coated Balloon) and Orsiro® (Drug Eluting Stent).\n\nIf you agree to participate in the study you will be invited to come back for a check-up angiogram 6 months after your procedure to make sure that the treatment has been a success. This is sometimes done in normal clinical practice, but it is not done routinely. You will not be charged for this additional test.",[650,27,651,652],"Diabetes Mellitus","de Novo Coronary Lesions","De Novo Stenosis",[650,654,655,656,657],"Coronary Artery Disease","Drug-coated Balloon","Drug-Eluting Stent","Target Vessel Failure","2025-12-10",{"date":660,"type":37},"2025-12-24",{"date":662,"type":37},"2025-08-06",{"date":664,"type":21},"2031-08-05",{"name":666,"class":77},"Royal College of Surgeons, Ireland",{"id":668,"slug":669,"hasResults":12,"nctId":670,"briefTitle":671,"officialTitle":672,"acronym":4,"eligibilityCriteria":673,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":384,"enrollmentInfo":674,"targetDuration":4,"studyType":22,"phases":676,"briefSummary":677,"conditions":678,"keywords":682,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":687,"lastUpdatePostDateStruct":688,"startDateStruct":690,"completionDateStruct":692,"leadSponsor":694,"locationsCount":159},"100581840","phase-4-effectiveness-of-interventional-therapy-for-non-flow-limiting-vulnerable-plaques-100581840","NCT06855537","Effectiveness of Interventional Therapy for Non-Flow-Limiting Vulnerable Plaques","Randomized Controlled Study on the Effectiveness of Interventional Therapy for Non-Flow-Limiting Vulnerable Plaques","Inclusion Criteria Clinical Inclusion Criteria 1. Males or non-pregnant females aged 18-80 years 2. Clinically diagnosed with acute coronary syndrome (including unstable angina, ST-segment elevation myocardial infarction, and non-ST-segment elevation myocardial infarction) 3. Patients willing and able to sign a written informed consent form Angiography, QFR, and OCT Inclusion Criteria\n\n1. Successful completion of angiography, QFR, and OCT examinations\n2. Successful treatment of all culprit lesions and flow-limited lesions (QFR ≤ 0.8)\n3. Reference vessel diameter between 2.5-4.0 mm on imaging assessment\n4. Lesion length ≤40 mm\n5. At least one significant stenosis (diameter reduction \\>50%) demonstrated by angiography, with QFR \\>0.80 and OCT-defined TCFA (fibrous cap thickness \\\u003C65μm, lipid arc \\>90°)\n\nExclusion Criteria Clinical Exclusion Criteria\n\n1. Patients with contraindications to dual antiplatelet therapy (DAPT) or planning to discontinue DAPT within one year\n2. Patients with other major illnesses and a life expectancy \\\u003C2 years\n3. Patients scheduled for cardiac surgery or major non-cardiac surgery\n4. Women who are breastfeeding, pregnant, or planning pregnancy during the study\n5. Patients with severe heart failure (NYHA class III-IV or Killip class III-IV or left ventricular ejection fraction \\\u003C35%)\n6. Patients with estimated glomerular filtration rate \\\u003C30 mL\u002F(min·1.73 m²)\n7. Patients with allergy to contrast agents or DES drugs\n8. Patients currently enrolled in other clinical studies Angiographic Exclusion Criteria\n\n1\\. Patients for whom CABG is the preferred treatment 2. Target lesion is a previously stented lesion 3. Target lesion is a post-bypass lesion 4. Target lesion is a heavily calcified or angulated lesion 5. Target lesion requires dual-stent technique 6. Target lesion is a left main coronary artery lesion.",{"count":675,"type":21},2190,[216],"The aim of this clinical trial is to explore the optimal preventative treatment strategy for non-flow-limiting vulnerable plaques. The main question it aims to answer is:\n\nCan interventional therapy further improve the outcome of non-flow-limiting vulnerable plaques on top of optimal pharmacologic therapy?\n\nResearchers will randomly assign patients who meet the inclusion criteria to preventative intervention plus optimal drug therapy (experimental group) or optimal drug therapy alone (control group).\n\nParticipants will:\n\nAssigned to the control group: optimized drug therapy consisting of lifestyle improvement and intensive drug therapy including high-dose statin or other therapy to achieve target levels (low-density lipoprotein cholesterol \\\u003C1.4 mmol\u002FL and decreased by 50% compared to the baseline). Lifestyle improvement and risk factor management included smoking cessation, nutritional optimization, physical activity, compliance with prescribed medications, and control of diabetes and hypertension.\n\nAssigned to the experimental group: all non-flow-limiting vulnerable plaques were treated with conventional second-generation drug-eluting stents. After the procedure, participants received dual antiplatelet therapy for about 12 months as well as other medications in the control group.",[27,679,680,681],"Vulnerable Coronary Plaques","Thin-cap fIbroatheroma","Acute Coronary Syndromes (ACS)",[274,172,683,684,685,686,681,679],"Randomized Controlled Trial (RCT)","Optimal Medical Therapy","Drug Eluting Stent (DES)","Quantitative Flow Ratio (QFR)","2025-11-25",{"date":689,"type":37},"2025-12-02",{"date":691,"type":37},"2025-11-03",{"date":693,"type":21},"2027-09-01",{"name":695,"class":77},"Beijing Anzhen Hospital"]