[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100560496":3},{"organization":4,"outcomesModule":7,"designInfo":32,"detailedDescription":35,"studyPopulation":36,"armGroups":37,"interventions":59,"overallOfficials":68,"centralContacts":72,"locations":77,"responsibleParty":92,"collaborators":31,"id":95,"slug":31,"hasResults":96,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":31,"eligibilityCriteria":100,"healthyVolunteers":96,"sex":101,"minAge":102,"maxAge":103,"enrollmentInfo":104,"targetDuration":107,"studyType":108,"phases":31,"briefSummary":109,"conditions":110,"keywords":31,"overallStatus":79,"whyStopped":31,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},{"fullName":5,"class":6},"Pusan National University Yangsan Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":31},[9],{"measure":10,"description":11,"timeFrame":12},"MACCE at 12 months after coronary artery intervention","MACCE defined as a composite of all-cause mortality, MI, and cerebrovascular events at 12 months after the index procedure","1 year after the procedure",[14,17,19,21,23,25,27,29],{"measure":15,"description":16,"timeFrame":12},"safety of procedures","All-cause mortality",{"measure":15,"description":18,"timeFrame":12},"occurrence of Cardiac mortality",{"measure":15,"description":20,"timeFrame":12},"occurrence of myocardial infarction",{"measure":15,"description":22,"timeFrame":12},"occurrence of Cerebrovascular events",{"measure":15,"description":24,"timeFrame":12},"occurrence of Target vessel revascularization (TVR) event",{"measure":15,"description":26,"timeFrame":12},"occurrence of Target lesion revascularization (TLR)",{"measure":15,"description":28,"timeFrame":12},"occurrence of Stent thrombosis",{"measure":15,"description":30,"timeFrame":12},"occurrence of Bleeding Academic Research Consortium (BARC) type 2 to 5 the procedure",null,{"allocation":31,"interventionModel":31,"interventionModelDescription":31,"primaryPurpose":31,"observationalModel":33,"timePerspective":34,"maskingInfo":31},"COHORT","PROSPECTIVE","For elderly patients aged 75 years or older undergoing percutaneous coronary intervention with Onyx family drug-eluting stents, observe the safety and efficacy of transitioning from dual antiplatelet therapy to single therapy for one year after one month of dual antiplatelet therapy","Patients who underwent percutaneous coronary intervention using Onyx family stents in those aged 75 years or older",[38,43,47,51,55],{"label":39,"type":31,"description":40,"interventionNames":41},"Aged 75 or more","Elderly patients aged 75 years or older",[42],"Device: Onyx family",{"label":44,"type":31,"description":45,"interventionNames":46},"Eligible for interventional procedures","\"Patients requiring PCI (Percutaneous Coronary Intervention) procedure",[42],{"label":48,"type":31,"description":49,"interventionNames":50},"Evidence of myocardial ischemia or coronary artery stenosis ≥ 50%","Patients with evidence of myocardial ischemia or coronary artery stenosis ≥ 50% on coronary angiography",[42],{"label":52,"type":31,"description":53,"interventionNames":54},"Able to take antiplatelets for at least 1 months after the procedure","Patients able to take antiplatelets after the procedure",[42],{"label":56,"type":31,"description":57,"interventionNames":58},"Patients who underwent coronary artery procedures with ZES stent","Patients who underwent coronary artery procedures with Onyx™ family stent",[42],[60],{"type":61,"name":62,"description":63,"armGroupLabels":64,"otherNames":65},"DEVICE","Onyx family","Safety and Efficacy of 1-Month DAPT in Elderly Patients at High Risk of Ischemia and Bleeding After Percutaneous Coronary Intervention with Onyx Family Stents",[52,39,44,48,56],[66,67],"Onyx frontier","Resolute Onyx",[69],{"name":70,"affiliation":5,"role":71},"Min Ku Chon, MD,PhD","PRINCIPAL_INVESTIGATOR",[73],{"name":70,"role":74,"phone":75,"phoneExt":31,"email":76},"CONTACT","82-10-2562-6258","chonmingu@gmail.com",[78],{"facility":5,"status":79,"city":80,"state":81,"zip":82,"country":83,"countryCode":31,"cosmosGeoPoint":84,"geoPoint":89,"contacts":90},"RECRUITING","Yangsan","Gyeongsangnam-do","50611","South Korea",{"type":85,"coordinates":86},"Point",[87,88],129.03358,35.34199,{"lat":88,"lon":87},[91],{"name":70,"role":74,"phone":75,"phoneExt":31,"email":76},{"type":71,"investigatorFullName":93,"investigatorTitle":94,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"Min Ku Chon","Associate Professor","100560496",false,"NCT06577896","The Study to Evaluate the Safety and Efficacy of the Onyx Family","Safety and Efficacy of 1-month Dual Antiplatelet Therapy in High Bleeding and Ischemic Risk Elderly Patients With Coronary Artery Disease After Implantation of Zotarolimus-eluting Coronary Stent System (Onyx Family, Medtronic, Minneapolis, MN); A Multicenter, Prospective, Observational Study","Inclusion Criteria:\n\n* Aged 75 or more.\n* Eligible for interventional procedures.\n* Evidence of myocardial ischemia or coronary artery stenosis ≥ 50%.\n* Able to take antiplatelets for at least 1 months after the procedure.\n* Patients who underwent coronary artery procedures with ZES (Medtronic, Minneapolis, MN, Onyx™ family) stent.\n\nExclusion Criteria:\n\n* The patient has a known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel, zotarolimus, and contrast media (patients with documented sensitivity to contrast media which can be effectively premedicated with steroids and diphenhydramine \\[eg, rash\\] may be enrolled. Those with true anaphylaxis to prior contrast media, however, should not be enrolled).\n* Patients with active pathologic bleeding.\n* Gastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery within 2 months.\n* History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia).\n* Noncardiac comorbid conditions are present with life expectancy \\<1 year or that may result in protocol noncompliance (per site investigator\\'s medical judgment).\n* Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.","ALL","75 Years","100 Years",{"count":105,"type":106},500,"ESTIMATED","1 Year","OBSERVATIONAL","Observation of the safety and efficacy of 1-month dual antiplatelet therapy (DAPT) after percutaneous coronary intervention using Onyx family stents in elderly patients aged 75 years or older",[111],"Coronary Artery Disease","2024-09-05",{"date":114,"type":115},"2024-09-19","ACTUAL",{"date":117,"type":115},"2022-06-09",{"date":119,"type":106},"2026-12-31",{"name":5,"class":6},1]