[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100472917":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":29,"responsibleParty":44,"collaborators":47,"id":51,"slug":10,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":52,"sex":58,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":10,"studyType":64,"phases":10,"briefSummary":65,"conditions":66,"keywords":70,"overallStatus":31,"whyStopped":10,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"Korea University Ansan Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients with multivessel CAD undergoing DCB PCI",null,"I. Patients with significant multi-vessel coronary artery disease will be screened.\n\nII. If the patient is found to have at least one lipid-rich plaque (LRP, LCBI\\>250) requiring revascularization (DS\\>70%) will undergo multi-vessel IVUS-NIRS imaging.\n\nIII. If multi-vessel NIRS screening revealed another LRP (LCBI\\>250) with DS\\\u003C70%, the patient will be enrolled.\n\nIV. The stenotic LRP lesion (DS\\>70%) will be subjected to DCB angioplasty while non-stenotic LRP lesion (DS\\\u003C70%) will be left unintervened and treated medically.\n\nV. Comparative lesions:\n\n1. DCB-treated LRP (DS\\>70%, maxLCBI\\>250)\n2. Unintervened, medically-treated LRP (DS\\\u003C70%, maxLCBI\\>250)",[13],"Device: SeQuent Please Neo",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DEVICE","SeQuent Please Neo","DCB angioplasty will be performed in accordance with the recent recommendations. Specifically, aggressive lesion predilation (balloon-to-artery ratio: 0.8 to 1.2) using either a plain balloon or a scoring balloon will be performed.",[9],[21],{"name":22,"affiliation":5,"role":23},"Sunwon Kim, MD, PhD","PRINCIPAL_INVESTIGATOR",[25],{"name":22,"role":26,"phone":27,"phoneExt":10,"email":28},"CONTACT","82-31-8099-6349","sunwon11@hanmail.net",[30],{"facility":5,"status":31,"city":32,"state":33,"zip":34,"country":35,"countryCode":10,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"RECRUITING","Ansan-si","Gyeonggi-do","15355","South Korea",{"type":37,"coordinates":38},"Point",[39,40],126.82194,37.32361,{"lat":40,"lon":39},[43],{"name":22,"role":26,"phone":27,"phoneExt":10,"email":28},{"type":23,"investigatorFullName":45,"investigatorTitle":46,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Sunwon Kim","Sunwon Kim, MD, PhD, Associate professor",[48],{"name":49,"class":50},"B. Braun Korea Co., Ltd.","INDUSTRY","100472917",false,"NCT05438121","STabilization of Atheroma by Lipid-reducing Effect of Drug-Coated Balloon (STABLE-DCB)","Drug-Coated Balloon Angioplasty Facilitates Rapid Reduction in Plaque Lipid Burden in Patients with Multivessel Coronary Artery Disease: a Serial NIRS-IVUS Imaging Study","STABLE-DCB","Inclusion Criteria:\n\n* Patients with significant multivessel coronary artery disease requiring revascularization\n* Any De novo lesions (reference vessel diameter of 2.25mm\\~4.0mm) suitable for DCB angioplasty\n* Lesion suitable for intravascular imagings\n* Written informed consent\n\nExclusion Criteria:\n\n* Hemodynamically unstable or cardiogenic shock\n* Left main stenotic lesion or graft vessel lesion\n* Visible angiographic thrombus, not resolved by balloon angioplasty\n* Pregnancy or breastfeeding\n* Comorbidities with life expectancy \\\u003C 12 months\n* Severe coronary calcification or tortuosity, hindering timely DCB delivery","ALL","18 Years","85 Years",{"count":62,"type":63},65,"ESTIMATED","OBSERVATIONAL","This study aims to investigate whether DCB angioplasty, compared to statin-based medical treatment alone, will lead to more reduction in plaque lipid burden as assessed by near infrared spectroscopy (NIRS) at 6-9 months following the index procedure.",[67,68,69],"Coronary Artery Disease","Atherosclerotic Plaque","De Novo Stenosis",[71,72,73,74],"drug coated balloon","Near infrared spectroscopy","NIRS-IVUS","De novo coronary lesion","2024-10-09",{"date":77,"type":78},"2024-10-15","ACTUAL",{"date":80,"type":78},"2022-10-13",{"date":82,"type":63},"2026-12-31",{"name":5,"class":6},1]