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