[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100650568":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":34,"locations":44,"responsibleParty":65,"collaborators":67,"id":124,"slug":125,"hasResults":126,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":10,"eligibilityCriteria":130,"healthyVolunteers":126,"sex":131,"minAge":10,"maxAge":10,"enrollmentInfo":132,"targetDuration":135,"studyType":136,"phases":10,"briefSummary":137,"conditions":138,"keywords":140,"overallStatus":149,"whyStopped":10,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":159},{"fullName":5,"class":6},"Xuanwu Hospital, Beijing","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Physician-Experience Cohort",null,"Participants undergoing coil embolization of an intracranial aneurysm in whom microcatheter shaping is performed according to the treating physician's experience, without assistance from the intelligent microcatheter shaping simulation technology.",[13],"Procedure: Physician-Experience Microcatheter Shaping",{"label":15,"type":10,"description":16,"interventionNames":17},"AI-Assisted Cohort","Participants undergoing coil embolization of an intracranial aneurysm in whom microcatheter shaping is performed with assistance from the intelligent microcatheter shaping simulation technology.",[18],"Device: AI-Assisted Microcatheter Shaping Simulation Technology",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":10},"PROCEDURE","Physician-Experience Microcatheter Shaping","Microcatheter shaping is planned and performed by the treating physician according to clinical experience without assistance from the intelligent microcatheter shaping simulation technology. The shaping approach is determined during routine clinical care and is not assigned by the study protocol.",[9],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":10},"DEVICE","AI-Assisted Microcatheter Shaping Simulation Technology","An artificial intelligence-based decision-support technology that analyzes three-dimensional cerebrovascular anatomy, assists with aneurysm localization and measurement, and provides a suggested microcatheter shaping plan for intracranial aneurysm coil embolization. Use of the technology is determined by routine clinical practice and is not assigned by the study protocol.",[15],[31],{"name":32,"affiliation":5,"role":33},"Hongqi Zhang","PRINCIPAL_INVESTIGATOR",[35,40],{"name":36,"role":37,"phone":38,"phoneExt":10,"email":39},"Hongqi Zhang, M.D","CONTACT","+8613601374152","xwzhanghq@163.com",{"name":41,"role":37,"phone":42,"phoneExt":10,"email":43},"Xin Su, M.D","+8618210685023","1258940078@qq.com",[45],{"facility":46,"status":10,"city":47,"state":10,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Xuanwu Hospital","Beijing","100053","China","CN",{"type":52,"coordinates":53},"Point",[54,55],116.39723,39.9075,{"lat":55,"lon":54},[58,60,63],{"name":59,"role":37,"phone":42,"phoneExt":10,"email":43},"Xin Su",{"name":61,"role":37,"phone":10,"phoneExt":10,"email":62},"Yongjie Ma, M.D","mayongjiexuanwu@163.com",{"name":61,"role":64,"phone":10,"phoneExt":10,"email":10},"SUB_INVESTIGATOR",{"type":66,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[68,71,73,75,78,80,82,84,86,88,90,92,94,96,98,100,102,104,106,108,110,112,114,116,118,120,122],{"name":69,"class":70},"Union Strong（Beijing）Technology Co.Ltd.","UNKNOWN",{"name":72,"class":6},"Qilu Hospital of Shandong University",{"name":74,"class":6},"Linyi People's Hospital",{"name":76,"class":77},"Shandong Provincial Hospital","OTHER_GOV",{"name":79,"class":77},"Tengzhou Central People's Hospital",{"name":81,"class":70},"The Second Qilu Hospital of Shandong University",{"name":83,"class":6},"Qingdao Municipal Hospital",{"name":85,"class":70},"The General Hospital of the PLA Northern Theater Command",{"name":87,"class":6},"Central Hospital Affiliated to Shenyang Medical Collage",{"name":89,"class":70},"Shenyang Sujiatun District Central Hospital",{"name":91,"class":70},"Northeast International Hospital",{"name":93,"class":6},"First Hospital of China Medical University",{"name":95,"class":6},"Affiliated Zhongshan Hospital of Dalian University",{"name":97,"class":70},"Panjin Liaoyou Gem Flower Hospital",{"name":99,"class":6},"Beijing Tiantan Hospital",{"name":101,"class":6},"Beijing Chao Yang Hospital",{"name":103,"class":6},"Chinese PLA General Hospital",{"name":105,"class":6},"Aerospace Center Hospital",{"name":107,"class":6},"Beijing Anzhen Hospital",{"name":109,"class":6},"Peking University Third Hospital",{"name":111,"class":6},"Seventh Medical Center of PLA Army General Hospital",{"name":113,"class":6},"Peking University International Hospital",{"name":115,"class":6},"Peking University First Hospital",{"name":117,"class":6},"Beijing Haidian Hospital",{"name":119,"class":6},"Beijing Tsinghua Changgeng Hospital",{"name":121,"class":77},"Beijing Hospital",{"name":123,"class":6},"Civil Aviation General Hospital","100650568","intelligent-microcatheter-shaping-for-intracranial-aneurysm-coil-embolization-100650568",false,"NCT07749404","Intelligent Microcatheter Shaping for Intracranial Aneurysm Coil Embolization","Safety and Effectiveness of Intelligent Microcatheter Shaping Simulation Technology in Coil Embolization of Intracranial Aneurysms: A Prospective, Multicenter, Observational, Real-World Registry Study","Inclusion Criteria:\n\n1. Age 18 years or older, with no restriction based on sex.\n2. Diagnosis of an intracranial aneurysm confirmed by computed tomography angiography, magnetic resonance angiography, or digital subtraction angiography, with the target aneurysm planned for treatment by coil embolization.\n3. Ability to understand the study requirements and treatment procedures and provision of written informed consent before any study-specific procedure.\n\nExclusion Criteria:\n\n1. Currently unable or expected to be unable to complete the 1-year follow-up.\n2. Participation in another clinical study that may affect the results of this study.\n3. Life expectancy of less than 1 year because of another disease or medical condition.\n4. Considered unsuitable for participation by the investigator.","ALL",{"count":133,"type":134},1438,"ESTIMATED","12 Months","OBSERVATIONAL","This prospective, multicenter, observational registry study will evaluate the real-world safety, effectiveness, and clinical value of artificial intelligence (AI)-assisted microcatheter shaping during coil embolization of intracranial aneurysms.\n\nAdults with an intracranial aneurysm who are scheduled to undergo coil embolization will be enrolled and followed for approximately 12 months. The study will not assign participants to a treatment strategy. All treatment decisions will be made by the treating physicians according to routine clinical practice.\n\nParticipants will be analyzed according to whether microcatheter shaping is performed based on the physician's experience alone or with assistance from an intelligent microcatheter shaping simulation technology. The study will evaluate major adverse events within 12 months, immediate aneurysm occlusion after the procedure, clinical and quality-of-life outcomes, follow-up imaging findings, serious adverse events, repeat treatment or rehospitalization, microcatheter delivery performance, and health care resource use. At least 1,438 participants are planned to be enrolled.",[139],"Intracranial Aneurysm",[141,142,143,144,145,139,146,147,148],"Artificial Intelligence","Computer-Assisted Microcatheter Shaping","Microcatheter Shaping","Coil Embolization","Endovascular Treatment","Real-World Registry","Medical Device","Neurointervention","NOT_YET_RECRUITING","2026-08-02",{"date":152,"type":153},"2026-08-06","ACTUAL",{"date":155,"type":134},"2026-08-01",{"date":157,"type":134},"2029-12",{"name":5,"class":6},1]