[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100594653":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":19,"responsibleParty":26,"collaborators":19,"id":28,"slug":29,"hasResults":30,"nctId":31,"briefTitle":32,"officialTitle":33,"acronym":19,"eligibilityCriteria":34,"healthyVolunteers":30,"sex":35,"minAge":36,"maxAge":37,"enrollmentInfo":38,"targetDuration":19,"studyType":41,"phases":42,"briefSummary":44,"conditions":45,"keywords":19,"overallStatus":47,"whyStopped":19,"lastUpdateSubmitDate":48,"lastUpdatePostDateStruct":49,"startDateStruct":52,"completionDateStruct":54,"leadSponsor":56,"locationsCount":19},{"fullName":5,"class":6},"Ton-Bridge Medical Tech. Co., Ltd","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental Group","EXPERIMENTAL","Intrasaccular Embolization Device",[13],"Device: Intrasaccular Embolization Device",[15],{"type":16,"name":11,"description":17,"armGroupLabels":18,"otherNames":19},"DEVICE","This is an intra-aneurysmal device intended for use in endovascular embolization of intracranial aneurysms.The intended therapeutic effect of this device is to line the neck of the aneurysm with a metallic structure that disrupts the inflow of blood, causing hemostasis within the aneurysm sac, and leading to thrombus formation within the implant.",[9],null,[21],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Xiaoyan Yang","CONTACT","18577072001","xy.yang@ton-bridge.com",{"type":27,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100594653","evaluation-of-a-novel-intrasaccular-embolization-device-for-the-treatment-of-intracranial-aneurysms-100594653",false,"NCT07022249","Evaluation of a Novel Intrasaccular Embolization Device for the Treatment of Intracranial Aneurysms","Efficacy and Safety of a Novel Intrasaccular Embolization Device for the Treatment of Intracranial Aneurysms : a Prospective, Multicenter, Single-arm Trial","Inclusion Criteria:\n\n* Patient must be 18-75 years of age at the time of screening.\n* Patient must have a single ruptured or unruptured IA requiring treatment.\n* Patient was able to comply with all aspects of the screening, evaluation, treatment, and the post-procedure follow-up schedule, signed and dated an written informed consent prior to initiation of any study procedures.\n\nExclusion Criteria:\n\n* Patient had an IA with characteristics unsuitable for endovascular treatment.\n* Patient had vessel characteristics, tortuosity or morphology which precluded safe access and support during treatment with study device.\n* Patient had vascular disease or other vascular anomaly that precluded the necessary access to the aneurysm for use of the study device.\n* Patient had vasculitis, an intracranial tumor (except benign tumors that do not require treatment) or any other intracranial vascular malformations on presentation.\n* Patient was taking anticoagulants or had a known blood dyscrasia, coagulopathy, or hemoglobinopathy.\n* Patient was pregnant.","ALL","18 Years","75 Years",{"count":39,"type":40},150,"ESTIMATED","INTERVENTIONAL",[43],"NA","The study is a prospective, multicenter single-arm cohort. The purpose of this study is to evaluate efficacy and safety of a novel intrasaccular embolization device for the treatment of intracranial aneurysms.",[46],"Intracranial Aneurysms","NOT_YET_RECRUITING","2025-06-08",{"date":50,"type":51},"2025-06-15","ACTUAL",{"date":53,"type":40},"2025-06",{"date":55,"type":40},"2027-06",{"name":5,"class":6}]