[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100521196":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":27,"locations":36,"responsibleParty":54,"collaborators":10,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":10,"eligibilityCriteria":62,"healthyVolunteers":58,"sex":63,"minAge":64,"maxAge":10,"enrollmentInfo":65,"targetDuration":68,"studyType":69,"phases":10,"briefSummary":70,"conditions":71,"keywords":10,"overallStatus":39,"whyStopped":10,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"Genoss Co., Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"OSFITTM drug-eluting stents.",null,"Treatment Group: Group of patients who received treatment with OSFITTM drug-eluting stents.\n\nSubgroup with OCT (OCT Subgroup): Subgroup of patients who underwent Optical Coherence Tomography (OCT) to verify stent placement accuracy.",[13],"Device: Genoss® DES system, Genoss® Osfit system",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Genoss® DES system, Genoss® Osfit system","This is a drug-eluting stent used to improve the diameter of the coronary artery in patients with symptomatic ischemic heart disease, with de novo lesions in the native coronary artery, where the reference vessel diameter ranges from 2.25mm to 5.00mm.",[9],[21],"GENOSS DES(Sirolimus Drug Eluting Coronary Stent) System, Osfit Sirolimus Drug Eluting Coronary Stent System",[23],{"name":24,"affiliation":25,"role":26},"seong-jae TaK, MD, PhD","Ajou University School of Medicine","PRINCIPAL_INVESTIGATOR",[28,32],{"name":24,"role":29,"phone":30,"phoneExt":10,"email":31},"CONTACT","820312195712","stjahk@gmail.com",{"name":33,"role":29,"phone":34,"phoneExt":10,"email":35},"Nayeong Lee, RN","820312195111","yellowfox240@gmail.com",[37],{"facility":38,"status":39,"city":40,"state":10,"zip":41,"country":42,"countryCode":10,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Ajou University Hospital","RECRUITING","Suwon","16499","South Korea",{"type":44,"coordinates":45},"Point",[46,47],127.00889,37.29111,{"lat":47,"lon":46},[50],{"name":51,"role":29,"phone":52,"phoneExt":10,"email":53},"Je Hwan Won, MD","82312195863","wonkwak@ajou.ac.kr",{"type":55,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100521196","efficacy-of-osfit-drug-eluting-stent-in-coronary-ostial-artery-stenosis-100521196",false,"NCT06066450","Efficacy of OSFIT Drug-Eluting Stent in Coronary Ostial Artery Stenosis","Efficacy of OSFIT Drug-Eluting Stent in Coronary Ostial Artery Stenosis: Multi-center, Prospective, Observational Study (OSFIT Registry)","Inclusion Criteria:\n\n1. Age 19 and above.\n2. Patients who have voluntarily decided to participate in this study and have provided written consent in accordance with the subject's agreement.\n3. Patients who have undergone percutaneous coronary intervention for stenosis within 5mm of the ostium of the coronary artery using OSFITTM drug-eluting stents. (In case of simultaneous stent placement for other lesions, only GenossTM drug-eluting stents should be used.)\n\nExclusion Criteria:\n\n1. Patients with contraindications to stent treatment and antiplatelet therapy or who have hypersensitivity.\n2. Patients with a life expectancy of less than 1 year.\n3. Pregnant or lactating women, or those wishing to become pregnant.\n4. Patients with ST-elevation myocardial infarction (STEMI).","ALL","19 Years",{"count":66,"type":67},1000,"ESTIMATED","12 Months","OBSERVATIONAL","The purpose of this observational study is to evaluate the long-term effectiveness and safety of the OSFIT drug-eluting stent designed to facilitate procedures in coronary artery lesions. Additionally, the study aims to verify the accuracy of stent placement in the lesion of interest using Optical Coherence Tomography (OCT) among subgroups of participants.\n\nThe primary endpoint was defined as the composite of target lesion failure (TLF) at the 12-month mark, including cardiac death, target vessel myocardial infarction (MI), or target lesion revascularization.",[72,73],"Drug-eluting Stent","Coronary Artery Disease","2023-10-30",{"date":76,"type":77},"2023-11-01","ACTUAL",{"date":79,"type":77},"2023-07-07",{"date":81,"type":67},"2026-12-31",{"name":5,"class":6},1]