Safety and Efficacy Study of Fabulous Stent Graft System for Stanford B Aortic Dissection
NCT ID: NCT04918212
Last Updated: 2021-11-08
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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COMPLETED
NA
148 participants
INTERVENTIONAL
2017-11-25
2020-10-13
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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Fabulous Stent Graft System
All patients received endovascular surgery using fabulous stent graft system
Fabulous Stent Graft System
All patients received endovascular surgery using fabulous stent graft system
Interventions
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Fabulous Stent Graft System
All patients received endovascular surgery using fabulous stent graft system
Eligibility Criteria
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Inclusion Criteria
2. The informed consent was signed by the patient or the legal representative;
3. Diagnosed with Stanford B aortic dissection;
4. The proximal anchoring area of is 18-42 mm in diameter, and not less than 15mm in length;
5. Has a suitable arterial approach and is suitable for surgical treatment.
Exclusion Criteria
2. Pregnant or breastfeeding ;
3. Has participated in clinical trials of other devices ；
4. History of aortic surgery or endovascular repair surgery ;
5. Allergic to contrast agents and anesthetics ;
6. Allergic to stents or conveyors ;
7. Patients with true or false aortic aneurysm;
8. History of myocardial infarction, TIA or cerebral infarction within the past 3 months;
9. Life expectancy is less than 12 months;
10. Other situations in which the investigator judges that not suitable for endovascular treatment .
18 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 Friendship Hospital, Capital Medical University
Beijing, , China
Chinese People's Liberation Army General Hospital
Beijing, , China
Peking University People's Hospital
Beijing, , China
Xiangya Hospital of Central South University
Changsha, , China
West China Hospital of Sichuan University
Chengdu, , China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, , China
Guangdong Provincial People's Hospital
Guangzhou, , China
Hainan Provincial People's Hospital
Haikou, , China
Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, , China
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, , China
Anhui Provincial Hospital
Hefei, , China
The First Affiliated Hospital of Kunming Medical College
Kunming, , China
Liuzhou Workers' Hospital
Liuzhou, , China
The Second Affiliated Hospital of Nanchang University
Nanchang, , China
Jiangsu Provincial People's Hospital
Nanjing, , China
The First Affiliated Hospital of Guangxi Medical University
Nanning, , China
The Ninth People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, , China
Zhongshan Hospital Affiliated to Fudan University
Shanghai, , China
The First Hospital of Hebei Medical University
Shijia Zhuang, , China
Tianjin Medical University General Hospital
Tianjin, , China
The First Affiliated Hospital of the Fourth Military Medical University
Xi'an, , China
Yantai Yuhuangding Hospital
Yantai, , China
First Affiliated Hospital of Zhengzhou University
Zhengzhou, , China
Henan Provincial People's Hospital
Zhengzhou, , China
Countries
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Other Identifiers
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WQ1601
Identifier Type: -
Identifier Source: org_study_id