[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100646286":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":10,"centralContacts":24,"locations":10,"responsibleParty":30,"collaborators":32,"id":35,"slug":36,"hasResults":37,"nctId":38,"briefTitle":39,"officialTitle":40,"acronym":10,"eligibilityCriteria":41,"healthyVolunteers":37,"sex":42,"minAge":10,"maxAge":10,"enrollmentInfo":43,"targetDuration":10,"studyType":46,"phases":10,"briefSummary":47,"conditions":48,"keywords":10,"overallStatus":52,"whyStopped":10,"lastUpdateSubmitDate":53,"lastUpdatePostDateStruct":54,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":10},{"fullName":5,"class":6},"W.L.Gore & Associates","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Aneurysm cohort",null,"Thoracic Aortic Aneurysm: 50 patients (including at least 5 surgically repaired patients who have the proximal landing zone that is a surgical graft)\n\nBefore 5 surgically repaired patients are enrolled if the other 45 patients are confirmed to be enrolled, enrollment of the other patients will be considered complete at that point, and only surgically repaired patients will continue to be enrolled.",[13],"Device: Gore® TAG® Thoracic Aortic Branch Stent Graft System",{"label":15,"type":10,"description":16,"interventionNames":17},"Dissection and Traumatic Transection cohort","* Complicated chronic Stanford type B aortic dissection (including dissecting aneurysm): at least 10 patients, and enrollment will be considered complete when the enrollment of 15 patients is confirmed.\n* Complicated Stanford type A (after surgical repair) aortic dissection: at least 10 patients, and enrollment will be considered complete when the enrollment of 15 patients is confirmed.\n\nIf, during the enrollment period for the dissection and traumatic transection cohort, an attempt is made to place TBE in patients with complicated acute Stanford type B aortic dissection or in patients with traumatic thoracic aortic transection, those patients will also be enrolled in the dissection and traumatic transection cohort.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":10},"DEVICE","Gore® TAG® Thoracic Aortic Branch Stent Graft System","Patients who attempted implant of TBE in Zone 0\u002F1 during the enrollment period for each indication (including patients in whom TBE is not placed in Zone 0\u002F1 area).",[9,15],[25],{"name":26,"role":27,"phone":28,"phoneExt":10,"email":29},"Manami Kaneko","CONTACT","+81-70-1433-0565","mkaneko@wlgore.com",{"type":31,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[33],{"name":34,"class":6},"CMIC Co, Ltd. Japan","100646286","tbe-zone-01-pms-in-japan-100646286",false,"NCT07691931","TBE Zone 0\u002F1 PMS in Japan","GORE® TAG® Thoracic Branch Endoprosthesis Zone 0\u002F1 Post-Market Surveillance in Japan","Inclusion Criteria:\n\nThose who are suitable for use of TBE according to the Japan package insert. \\[Reference: Purpose of Use or Effects of TBE at the time of launch\\] The GORE® TAG® Thoracic Branch Endoprosthesis is intended for use in patients with the following diseases of the aortic arch and descending thoracic aortic lesions who fulfill anatomical requirements for treatment of such diseases while preserving blood flow to a single aortic arch target branch vessel.\n\n* Thoracic aortic aneurysm\n* Traumatic transection\n* Complicated Stanford type A (after surgical repair) and B aortic dissection (including dissecting aortic aneurysm) who have not responded to medical therapy\n\nThe GORE® TAG® Thoracic Branch Endoprosthesis may be used in combination with designated stent grafts with validated efficacy and safety.\n\nExclusion Criteria:\n\nN\u002FA","ALL",{"count":44,"type":45},75,"ESTIMATED","OBSERVATIONAL","The goal of this surveillance is to confirm the safety and efficacy of TBE under actual use in the Zone 0\u002F1 lesion on post-marketing usage conditions.",[49,50,51],"Aneurysm of Aorta, Thoracic","Dissection of Aorta, Thoracic","Trauma","NOT_YET_RECRUITING","2026-07-06",{"date":55,"type":56},"2026-07-09","ACTUAL",{"date":58,"type":45},"2026-09",{"date":60,"type":45},"2035-09",{"name":5,"class":6}]