[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100545705":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":26,"responsibleParty":238,"collaborators":19,"id":240,"slug":241,"hasResults":242,"nctId":243,"briefTitle":244,"officialTitle":245,"acronym":19,"eligibilityCriteria":246,"healthyVolunteers":242,"sex":247,"minAge":248,"maxAge":249,"enrollmentInfo":250,"targetDuration":19,"studyType":253,"phases":254,"briefSummary":256,"conditions":257,"keywords":19,"overallStatus":29,"whyStopped":19,"lastUpdateSubmitDate":259,"lastUpdatePostDateStruct":260,"startDateStruct":263,"completionDateStruct":265,"leadSponsor":267,"locationsCount":268},{"fullName":5,"class":6},"Hangzhou Endonom Medtech Co., Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"WeFlow-Tribranch embedded aortic Triple-branch arch Stent Graft system","EXPERIMENTAL","Participants will be treated with WeFlow-Tribranch embedded aortic Triple-branch arch Stent Graft system",[13],"Device: WeFlow-Tribranch embedded aortic Triple-branch arch Stent Graft system",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DEVICE","The WeFlow-Tribranch embedded aortic Triple-branch arch Stent Graft system consists of the embedded ascending aorta stent graft system, the arch aorta stent graft system, the aortic extension stent graft system and the branch stent system.",[9],null,[21],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Wei Guo","CONTACT","13910758706","Pla301dml@vip.sina.com",[27,42,49,60,71,82,93,101,112,123,134,145,156,164,175,186,194,205,216,227],{"facility":28,"status":29,"city":30,"state":19,"zip":19,"country":31,"countryCode":32,"cosmosGeoPoint":33,"geoPoint":38,"contacts":39},"Beijing Anzhen Hospital, Capital Medical University","RECRUITING","Beijing","China","CN",{"type":34,"coordinates":35},"Point",[36,37],116.39723,39.9075,{"lat":37,"lon":36},[40],{"name":41,"role":23,"phone":19,"phoneExt":19,"email":19},"Zhong Chen",{"facility":43,"status":29,"city":30,"state":19,"zip":19,"country":31,"countryCode":32,"cosmosGeoPoint":44,"geoPoint":46,"contacts":47},"Chinese PLA Gencral Hosptial",{"type":34,"coordinates":45},[36,37],{"lat":37,"lon":36},[48],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":19},{"facility":50,"status":29,"city":51,"state":19,"zip":19,"country":31,"countryCode":32,"cosmosGeoPoint":52,"geoPoint":56,"contacts":57},"The First Hospital of Jilin University","Changchun",{"type":34,"coordinates":53},[54,55],125.32278,43.88,{"lat":55,"lon":54},[58],{"name":59,"role":23,"phone":19,"phoneExt":19,"email":19},"Yongsheng Gao",{"facility":61,"status":29,"city":62,"state":19,"zip":19,"country":31,"countryCode":32,"cosmosGeoPoint":63,"geoPoint":67,"contacts":68},"Xiangya Hospital of Central South University","Changsha",{"type":34,"coordinates":64},[65,66],112.97087,28.19874,{"lat":66,"lon":65},[69],{"name":70,"role":23,"phone":19,"phoneExt":19,"email":19},"Wei Wang",{"facility":72,"status":29,"city":73,"state":19,"zip":19,"country":31,"countryCode":32,"cosmosGeoPoint":74,"geoPoint":78,"contacts":79},"West China Hospital of Sichuan University","Chengdu",{"type":34,"coordinates":75},[76,77],104.06667,30.66667,{"lat":77,"lon":76},[80],{"name":81,"role":23,"phone":19,"phoneExt":19,"email":19},"Jia Hu",{"facility":83,"status":29,"city":84,"state":19,"zip":19,"country":31,"countryCode":32,"cosmosGeoPoint":85,"geoPoint":89,"contacts":90},"Guangdong Provincial Hospital of Traditional Chinese Medicine","Guangzhou",{"type":34,"coordinates":86},[87,88],113.25,23.11667,{"lat":88,"lon":87},[91],{"name":92,"role":23,"phone":19,"phoneExt":19,"email":19},"Xiaoping Fan",{"facility":94,"status":29,"city":84,"state":19,"zip":19,"country":31,"countryCode":32,"cosmosGeoPoint":95,"geoPoint":97,"contacts":98},"The First Affiliated Hospital ,Sun Yat-sen University",{"type":34,"coordinates":96},[87,88],{"lat":88,"lon":87},[99],{"name":100,"role":23,"phone":19,"phoneExt":19,"email":19},"Guangqi Chang",{"facility":102,"status":29,"city":103,"state":19,"zip":19,"country":31,"countryCode":32,"cosmosGeoPoint":104,"geoPoint":108,"contacts":109},"The First Affiliated Hospital of Harbin Medical University","Harbin",{"type":34,"coordinates":105},[106,107],126.65,45.75,{"lat":107,"lon":106},[110],{"name":111,"role":23,"phone":19,"phoneExt":19,"email":19},"Baodong Xie",{"facility":113,"status":29,"city":114,"state":19,"zip":19,"country":31,"countryCode":32,"cosmosGeoPoint":115,"geoPoint":119,"contacts":120},"Shandong Provincial Hospital","Jinan",{"type":34,"coordinates":116},[117,118],116.99722,36.66833,{"lat":118,"lon":117},[121],{"name":122,"role":23,"phone":19,"phoneExt":19,"email":19},"Xuejun Wu",{"facility":124,"status":29,"city":125,"state":19,"zip":19,"country":31,"countryCode":32,"cosmosGeoPoint":126,"geoPoint":130,"contacts":131},"The First People's Hospital of Yunnan Province","Kunming",{"type":34,"coordinates":127},[128,129],102.71833,25.03889,{"lat":129,"lon":128},[132],{"name":133,"role":23,"phone":19,"phoneExt":19,"email":19},"Kunmei Gong",{"facility":135,"status":29,"city":136,"state":19,"zip":19,"country":31,"countryCode":32,"cosmosGeoPoint":137,"geoPoint":141,"contacts":142},"The Second Affiliated Hospital Of Nanchang University","Nanchang",{"type":34,"coordinates":138},[139,140],115.85306,28.68396,{"lat":140,"lon":139},[143],{"name":144,"role":23,"phone":19,"phoneExt":19,"email":19},"Weimin Zhou",{"facility":146,"status":29,"city":147,"state":19,"zip":19,"country":31,"countryCode":32,"cosmosGeoPoint":148,"geoPoint":152,"contacts":153},"Nanjing First Hospital","Nanjing",{"type":34,"coordinates":149},[150,151],118.77778,32.06167,{"lat":151,"lon":150},[154],{"name":155,"role":23,"phone":19,"phoneExt":19,"email":19},"Xin Chen",{"facility":157,"status":29,"city":147,"state":19,"zip":19,"country":31,"countryCode":32,"cosmosGeoPoint":158,"geoPoint":160,"contacts":161},"The First Affiliated Hospital of Nanjing Medical University",{"type":34,"coordinates":159},[150,151],{"lat":151,"lon":150},[162],{"name":163,"role":23,"phone":19,"phoneExt":19,"email":19},"Yongfeng Shao",{"facility":165,"status":29,"city":166,"state":19,"zip":19,"country":31,"countryCode":32,"cosmosGeoPoint":167,"geoPoint":171,"contacts":172},"The Affiliated Hospital Of Qingdao University","Qingdao",{"type":34,"coordinates":168},[169,170],120.38042,36.06488,{"lat":170,"lon":169},[173],{"name":174,"role":23,"phone":19,"phoneExt":19,"email":19},"Mingjin Guo",{"facility":176,"status":29,"city":177,"state":19,"zip":19,"country":31,"countryCode":32,"cosmosGeoPoint":178,"geoPoint":182,"contacts":183},"Shanghai Chest Hospital","Shanghai",{"type":34,"coordinates":179},[180,181],121.45806,31.22222,{"lat":181,"lon":180},[184],{"name":185,"role":23,"phone":19,"phoneExt":19,"email":19},"Dan Zhu",{"facility":187,"status":29,"city":177,"state":19,"zip":19,"country":31,"countryCode":32,"cosmosGeoPoint":188,"geoPoint":190,"contacts":191},"Zhongshan Hospital, Fudan University",{"type":34,"coordinates":189},[180,181],{"lat":181,"lon":180},[192],{"name":193,"role":23,"phone":19,"phoneExt":19,"email":19},"Weiguo Fu",{"facility":195,"status":29,"city":196,"state":19,"zip":19,"country":31,"countryCode":32,"cosmosGeoPoint":197,"geoPoint":201,"contacts":202},"The First Affiliated Hospital of China Medical University","Shenyang",{"type":34,"coordinates":198},[199,200],123.43278,41.79222,{"lat":200,"lon":199},[203],{"name":204,"role":23,"phone":19,"phoneExt":19,"email":19},"Shijie Xin",{"facility":206,"status":29,"city":207,"state":19,"zip":19,"country":31,"countryCode":32,"cosmosGeoPoint":208,"geoPoint":212,"contacts":213},"The First Affiliated Hospital of PLA Air Force Military Medical University","Xi'an",{"type":34,"coordinates":209},[210,211],108.92861,34.25833,{"lat":211,"lon":210},[214],{"name":215,"role":23,"phone":19,"phoneExt":19,"email":19},"Jian Zuo",{"facility":217,"status":29,"city":218,"state":19,"zip":19,"country":31,"countryCode":32,"cosmosGeoPoint":219,"geoPoint":223,"contacts":224},"Xiamen Cardiovascular Hospital","Xiamen",{"type":34,"coordinates":220},[221,222],118.08187,24.47979,{"lat":222,"lon":221},[225],{"name":226,"role":23,"phone":19,"phoneExt":19,"email":19},"Xijie Wu",{"facility":228,"status":29,"city":229,"state":19,"zip":19,"country":31,"countryCode":32,"cosmosGeoPoint":230,"geoPoint":234,"contacts":235},"First Affiliated Hospital of Zhengzhou University","Zhengzhou",{"type":34,"coordinates":231},[232,233],113.64861,34.75778,{"lat":233,"lon":232},[236],{"name":237,"role":23,"phone":19,"phoneExt":19,"email":19},"Zhen Li",{"type":239,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100545705","guos-aortic-arch-reconstruction-a-multicenter-prospective-study-of-the-novel-weflow-tribranch-system-genius-study-100545705",false,"NCT06385379","Guo's Aortic Arch Reconstruction: A Multicenter, Prospective Study of the Novel WeFlow-Tribranch System (GENIUS Study)","Guo's Aortic Arch Reconstruction: A Multicenter, Prospective Study of the Novel WeFlow-Tribranch Unique Embedded Aortic Triple-branch Arch Stent Graft System (GENIUS Study)","Inclusion Criteria:\n\n1. Patients aged 18 to 80 years old;\n2. Diagnosed with aortic arch lesions requiring intervention, including true aortic arch aneurysms, pseudo-aortic arch aneurysms, and ulcers involving the aortic arch;\n3. Showing a suitable vascular condition, including:\n\n   * Ascending aorta length greater than 50 mm (from the aortic sinusoid junction to the proximal cardiac margin of the innominate artery).\n   * Ascending aorta diameter ≥ 24 mm and ≤ 48 mm;\n   * Proximal anchoring zone length ≥ 30 mm;\n   * Branch arteries to be reconstructed were ≤ 24 mm and ≥ 6 mm in diameter and ≥ 20 mm in length;\n   * Suitable arterial access for endovascular interventional treatment;\n4. Able to understand the purpose of the trial, participate in the trial voluntarily with informed consent form signed by the patient him\u002Fherself or his or her legal representative, and willing to complete follow-up visits as required under the protocol.\n5. Subjects were assessed as high risk for surgery by at least two investigators or judged to have significant surgical contraindications. Recommended reference criteria were a European system for cardiac operative risk evaluation (EuroScore) score of 6 or higher or other surgical risk factors as judged by the physician team.\n\nExclusion Criteria:\n\n1. Experienced systemic infection during past three months;\n2. Neck surgery was performed within 3 months;\n3. Previous endovascular interventional treatment involving the aortic arch was performed;\n4. Infectious aortic disease, Takayasu arteritis, Marfan syndrome (or other connective tissue diseases );\n5. Severe stenosis, calcification, thrombosis, or tortuosity of the branch artery to be reconstructed;\n6. Heart transplant;\n7. Suffered Myocardial Infarction or Stroke during past three months;\n8. Class IV heart function (NYHA classification);\n9. Active peptic ulcers or upper gastrointestinal bleeding occurring within the previous three months;\n10. Hematological abnormality, defined as follows: Leukopenia (WBC \\\u003C 3 ×109\u002FL), acute anemia (Hb \\\u003C 90 g\u002FL), Coagulation disorders, thrombocytopenia (PLT count \\\u003C 50 × 109\u002FL);\n11. Renal insufficiency, creatinine \\> 150 umol\u002FL and\u002For end-stage renal disease requiring renal dialysis;\n12. Pregnant or breastfeeding;\n13. Allergies to contrast agents;\n14. Life expectancy of less than 12 months;\n15. Participating in another drug or device research;\n16. Any other disease or abnormality that the investigators believe may hinder endovascular interventional treatment.","ALL","18 Years","80 Years",{"count":251,"type":252},90,"ESTIMATED","INTERVENTIONAL",[255],"NA","A prospective ,Multiple Center Study About the Safety and Efficacy of WeFlow-Tribranch Embedded Aortic Triple-branch Arch Stent Graft System manufactured by EndoNom Medtech (Hangzhou) Co., Ltd. for true\u002Fpseudo aortic arch aneurysms and ulcers involving aortic arch . (GENIUS Study)",[258],"Aortic Arch Aneurysm","2026-04-27",{"date":261,"type":262},"2026-05-01","ACTUAL",{"date":264,"type":262},"2024-06-30",{"date":266,"type":252},"2030-12-31",{"name":5,"class":6},20]