[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100529748":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":44,"responsibleParty":60,"collaborators":64,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":26,"eligibilityCriteria":81,"healthyVolunteers":77,"sex":82,"minAge":83,"maxAge":84,"enrollmentInfo":85,"targetDuration":26,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":94,"overallStatus":74,"whyStopped":26,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Soonchunhyang University Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Wolverine cutting balloon group","EXPERIMENTAL","Patients who received PCI with Wolverine cutting balloon to modify calcified coronary lesion",[13],"Device: Wolverine cutting balloon",{"label":15,"type":16,"description":17,"interventionNames":18},"NC(Non-compliant) balloon group","ACTIVE_COMPARATOR","Patients who received PCI with Non-compliant balloon to modify calcified coronary lesion",[19],"Device: Non-compliant balloon",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Wolverine cutting balloon","As an intervention method for calcified coronary lesion modification, intervention group will undergo PCI after using the Wolverine cutting balloon for calcium modification.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Non-compliant balloon","As an intervention method for calcified coronary lesion modification, intervention group will undergo PCI after using the Non-compliant balloon for calcium modification.",[15],[32],{"name":33,"affiliation":5,"role":34},"Jon Suh, PhD","STUDY_CHAIR",[36,40],{"name":33,"role":37,"phone":38,"phoneExt":26,"email":39},"CONTACT","082-10-3407-3843","immanuel@schmc.ac.kr",{"name":41,"role":37,"phone":42,"phoneExt":26,"email":43},"Eunbin Park","082-10-9180-7781","popori114@naver.com",[45],{"facility":5,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":26,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"RECRUITING","Bucheon-si","Gyeonggi-do","14584","South Korea",{"type":52,"coordinates":53},"Point",[54,55],126.78306,37.49889,{"lat":55,"lon":54},[58,59],{"name":33,"role":37,"phone":38,"phoneExt":26,"email":39},{"name":41,"role":37,"phone":42,"phoneExt":26,"email":43},{"type":61,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Jon Suh","Jon Suh, MD\u002FPhD, Principal investigator",[65,68,70,72],{"name":66,"class":67},"Boston Scientific Corporation","INDUSTRY",{"name":69,"class":6},"Eulji University",{"name":71,"class":6},"The Catholic University of Korea",{"name":73,"class":74},"Hanil General Hospital, Korea","UNKNOWN","100529748","assessment-of-cutting-balloon-angioplasty-with-everolimus-eluting-stentees-in-the-treatment-of-coronary-calcified-lesionccl-guided-by-intravascular-ultrasonographyivus-100529748",false,"NCT06177808","Assessment of Cutting-Balloon Angioplasty With Everolimus-Eluting Stent(EES) in the Treatment of Coronary Calcified Lesion(CCL) Guided by Intravascular Ultrasonography(IVUS)","Assessment of Cutting-Balloon Angioplasty With Novel Bioabsorbable Polymer-Coated, Everolimus-Eluting Stent in the Treatment of Calcified Coronary Lesions Guided by Intravascular Ultrasound","Inclusion Criteria:\n\n1. Coronary artery disease including ISR or de novo lesion with a stenosis of ≥ 70%\n2. Target lesion calcification (an arch of calcium at least 100 degrees) was confirmed by imaging studies\n3. A reference vessel diameter between 2.0 and 4.0mm and deemed suitable for PCI\n\nExclusion Criteria:\n\n1. Extremely tortuous or angulated lesions\n2. Lesions with dissection before balloon pre-dilatation\n3. Lesions within the vein graft\n4. Extremely narrow lesions which need to rotational atherectomy\n5. STEMI\n6. Comorbidities which preclude the achievement of one year follow up","ALL","19 Years","90 Years",{"count":86,"type":87},250,"ESTIMATED","INTERVENTIONAL",[90],"NA","The study seeks to address the clinical question of how effectively a novel cutting balloon (Wolverine™) can modify calcified lesions for stent implantation in comparison with a non-compliant (NC) balloon, particularly when used alongside a bioabsorbable polymer-coated everolimus-eluting coronary stent (Synergy™).\n\nMost previous researches on cutting balloons focused on only severe calcifications and had limitations such as small sample sizes with retrospective designs, emphasizing on short-term imaging outcomes. This study differs by including mild to severe calcifications and evaluating long-term clinical outcomes, intraprocedural factors, and operator convenience. It aims to provide evidence that could potentially expand the indications for cutting balloon use and inform insurance coverage policies.\n\nThe objective of the study is to test the safety and efficacy of the cutting balloon in preparing calcified coronary lesions for stent insertion compared to conventional methods.",[93],"Coronary Artery Disease",[95,96,97,98,99],"Cutting balloon","Calcified coronary lesion","Calcium modification","Balloon angioplasty","Intravascular ultrasound","2023-12-26",{"date":102,"type":103},"2024-01-03","ACTUAL",{"date":105,"type":87},"2024-01-01",{"date":107,"type":87},"2025-12-31",{"name":5,"class":6},1]