nctId: NCT06385379 id: WQ21-2301 briefTitle: Guo's Aortic Arch Reconstruction: A Multicenter, Prospective Study of the Novel WeFlow-Tribranch System (GENIUS Study) overallStatus: RECRUITING date: 2024-04-30 date: 2025-12-31 date: 2030-12-31 date: 2024-04-26 date: 2024-04-26 name: Hangzhou Endonom Medtech Co., Ltd. class: INDUSTRY briefSummary: 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/pseudo aortic arch aneurysms and ulcers involving aortic arch . (GENIUS Study) conditions: Aortic Arch Aneurysm studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 90 type: ESTIMATED name: WeFlow-Tribranch embedded aortic Triple-branch arch Stent Graft system measure: Rate of all-cause mortality and major stroke within 12 months after surgery measure: Rate of immediate technical success following surgery measure: Rate of aortic aneurysm progression under control measure: Incidence of Type I or Type III endoleak measure: Incidence of aortic covered stent graft displacement measure: Postoperative branch vessel patency rate measure: Rate of conversion to thoracotomy or secondary intervention measure: Rate of major adverse events measure: Rate of aortic aneurysm-related mortality measure: Incidence of severe adverse events measure: Incidence of device-related adverse events sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beijing Anzhen Hospital, Capital Medical University status: RECRUITING city: Beijing country: China name: Zhong Chen role: CONTACT lat: 39.9075 lon: 116.39723 facility: Chinese PLA Gencral Hosptial status: RECRUITING city: Beijing country: China name: Wei Guo role: CONTACT phone: 13910758706 lat: 39.9075 lon: 116.39723 facility: The First Hospital of Jilin University status: RECRUITING city: Changchun country: China name: Yongsheng Gao role: CONTACT lat: 43.88 lon: 125.32278 facility: Xiangya Hospital of Central South University status: RECRUITING city: Changsha country: China name: Wei Wang role: CONTACT lat: 28.19874 lon: 112.97087 facility: West China Hospital of Sichuan University status: RECRUITING city: Chengdu country: China name: Jia Hu role: CONTACT lat: 30.66667 lon: 104.06667 facility: Guangdong Provincial Hospital of Traditional Chinese Medicine status: RECRUITING city: Guangzhou country: China name: Xiaoping Fan role: CONTACT lat: 23.11667 lon: 113.25 facility: The First Affiliated Hospital ,Sun Yat-sen University status: RECRUITING city: Guangzhou country: China name: Guangqi Chang role: CONTACT lat: 23.11667 lon: 113.25 facility: The First Affiliated Hospital of Harbin Medical University status: RECRUITING city: Harbin country: China name: Baodong Xie role: CONTACT lat: 45.75 lon: 126.65 facility: Shandong Provincial Hospital status: RECRUITING city: Jinan country: China name: Xuejun Wu role: CONTACT lat: 36.66833 lon: 116.99722 facility: The First People's Hospital of Yunnan Province status: RECRUITING city: Kunming country: China name: Kunmei Gong role: CONTACT lat: 25.03889 lon: 102.71833 facility: The Second Affiliated Hospital Of Nanchang University status: RECRUITING city: Nanchang country: China name: Weimin Zhou role: CONTACT lat: 28.68396 lon: 115.85306 facility: Nanjing First Hospital status: RECRUITING city: Nanjing country: China name: Xin Chen role: CONTACT lat: 32.06167 lon: 118.77778 facility: The First Affiliated Hospital of Nanjing Medical University status: RECRUITING city: Nanjing country: China name: Yongfeng Shao role: CONTACT lat: 32.06167 lon: 118.77778 facility: The Affiliated Hospital Of Qingdao University status: RECRUITING city: Qingdao country: China name: Mingjin Guo role: CONTACT lat: 36.06488 lon: 120.38042 facility: Shanghai Chest Hospital status: RECRUITING city: Shanghai country: China name: Dan Zhu role: CONTACT lat: 31.22222 lon: 121.45806 facility: Zhongshan Hospital, Fudan University status: RECRUITING city: Shanghai country: China name: Weiguo Fu role: CONTACT lat: 31.22222 lon: 121.45806 facility: The First Affiliated Hospital of China Medical University status: RECRUITING city: Shenyang country: China name: Shijie Xin role: CONTACT lat: 41.79222 lon: 123.43278 facility: Xiamen Cardiovascular Hospital status: RECRUITING city: Xiamen country: China name: Xijie Wu role: CONTACT lat: 24.47979 lon: 118.08187 facility: The First Affiliated Hospital of PLA Air Force Military Medical University status: RECRUITING city: Xian country: China name: Jian Zuo role: CONTACT lat: 34.25833 lon: 108.92861 facility: First Affiliated Hospital of Zhengzhou University status: RECRUITING city: Zhengzhou country: China name: Zhen Li role: CONTACT lat: 34.75778 lon: 113.64861 hasResults: False