Guo's Aortic Arch Reconstruction: A Multicenter, Prospective Study of the Novel WeFlow-Tribranch System (GENIUS Study)
NCT ID: NCT06385379
Last Updated: 2024-05-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
90 participants
INTERVENTIONAL
2024-06-30
2030-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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WeFlow-Tribranch embedded aortic Triple-branch arch Stent Graft system
Participants will be treated with WeFlow-Tribranch embedded aortic Triple-branch arch Stent Graft system
WeFlow-Tribranch embedded aortic Triple-branch arch Stent Graft system
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.
Interventions
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WeFlow-Tribranch embedded aortic Triple-branch arch Stent Graft system
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.
Eligibility Criteria
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Inclusion Criteria
2. Diagnosed with aortic arch lesions requiring intervention, including true aortic arch aneurysms, pseudo-aortic arch aneurysms, and ulcers involving the aortic arch;
3. Showing a suitable vascular condition, including:
* Ascending aorta length greater than 50 mm (from the aortic sinusoid junction to the proximal cardiac margin of the innominate artery).
* Ascending aorta diameter ≥ 24 mm and ≤ 48 mm;
* Proximal anchoring zone length ≥ 30 mm;
* Branch arteries to be reconstructed were ≤ 24 mm and ≥ 6 mm in diameter and ≥ 20 mm in length;
* Suitable arterial access for endovascular interventional treatment;
4. Able to understand the purpose of the trial, participate in the trial voluntarily with informed consent form signed by the patient him/herself or his or her legal representative, and willing to complete follow-up visits as required under the protocol.
5. 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.
Exclusion Criteria
2. Neck surgery was performed within 3 months;
3. Previous endovascular interventional treatment involving the aortic arch was performed;
4. Infectious aortic disease, Takayasu arteritis, Marfan syndrome (or other connective tissue diseases );
5. Severe stenosis, calcification, thrombosis, or tortuosity of the branch artery to be reconstructed;
6. Heart transplant;
7. Suffered Myocardial Infarction or Stroke during past three months;
8. Class IV heart function (NYHA classification);
9. Active peptic ulcers or upper gastrointestinal bleeding occurring within the previous three months;
10. Hematological abnormality, defined as follows: Leukopenia (WBC \< 3 ×109/L), acute anemia (Hb \< 90 g/L), Coagulation disorders, thrombocytopenia (PLT count \< 50 × 109/L);
11. Renal insufficiency, creatinine \> 150 umol/L and/or end-stage renal disease requiring renal dialysis;
12. Pregnant or breastfeeding;
13. Allergies to contrast agents;
14. Life expectancy of less than 12 months;
15. Participating in another drug or device research;
16. Any other disease or abnormality that the investigators believe may hinder endovascular interventional treatment.
18 Years
80 Years
ALL
No
Sponsors
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Hangzhou Endonom Medtech Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Beijing Anzhen Hospital, Capital Medical University
Beijing, , China
Chinese PLA Gencral Hosptial
Beijing, , China
The First Hospital of Jilin University
Changchun, , China
Xiangya Hospital of Central South University
Changsha, , China
West China Hospital of Sichuan University
Chengdu, , China
Guangdong Provincial Hospital of Traditional Chinese Medicine
Guangzhou, , China
The First Affiliated Hospital ,Sun Yat-sen University
Guangzhou, , China
The First Affiliated Hospital of Harbin Medical University
Harbin, , China
Shandong Provincial Hospital
Jinan, , China
The First People's Hospital of Yunnan Province
Kunming, , China
The Second Affiliated Hospital Of Nanchang University
Nanchang, , China
Nanjing First Hospital
Nanjing, , China
The First Affiliated Hospital of Nanjing Medical University
Nanjing, , China
The Affiliated Hospital Of Qingdao University
Qingdao, , China
Shanghai Chest Hospital
Shanghai, , China
Zhongshan Hospital, Fudan University
Shanghai, , China
The First Affiliated Hospital of China Medical University
Shenyang, , China
The First Affiliated Hospital of PLA Air Force Military Medical University
Xi'an, , China
Xiamen Cardiovascular Hospital
Xiamen, , China
First Affiliated Hospital of Zhengzhou University
Zhengzhou, , China
Countries
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Central Contacts
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Facility Contacts
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Zhong Chen
Role: primary
Wei Guo
Role: primary
Yongsheng Gao
Role: primary
Wei Wang
Role: primary
Jia Hu
Role: primary
Xiaoping Fan
Role: primary
Guangqi Chang
Role: primary
Baodong Xie
Role: primary
Xuejun Wu
Role: primary
Kunmei Gong
Role: primary
Weimin Zhou
Role: primary
Xin Chen
Role: primary
Yongfeng Shao
Role: primary
Mingjin Guo
Role: primary
Dan Zhu
Role: primary
Weiguo Fu
Role: primary
Shijie Xin
Role: primary
Jian Zuo
Role: primary
Xijie Wu
Role: primary
Zhen Li
Role: primary
Other Identifiers
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WQ21-2301
Identifier Type: -
Identifier Source: org_study_id
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