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A prospective, multi-center, objective performance criteria clinical trial to evaluate the safety and efficacy of Fabulous Stent Graft System manufactured by Hangzhou Endonom Medtech Co., Ltd. for Stanford B Aortic Dissection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fabulous Stent Graft System | Experimental | All patients received endovascular surgery using fabulous stent graft system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fabulous Stent Graft System | Device | All patients received endovascular surgery using fabulous stent graft system |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with no incidence of major surgical or device related adverse events rate | Surgical or device related major adverse events (MAE) : death, respiratory failure, renal failure, stroke, paraplegia, intestinal ischemia, cardiovascular and vascular complications caused by surgery or device | within 30 days after surgery |
| Clinical success rate | Clinical success is defined as : no displacement of Stent Graft System, no type I or III endoleak requiring treatment, no enlargement of the false lumen, thrombosis of the false lumen, and no rupture of the dissection | 12 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| adverse event rate | within 12 months after surgery | |
| Immediate delivery success rate | The stent graft system was successfully transported to the correct position and released successfully | immediately after the surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Friendship Hospital, Capital Medical University | Beijing | China | ||||
| Chinese People's Liberation Army General Hospital |
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| Immediate operation successful rate | After the operation, angiographic observation showed that the proximal covered stent was in an appropriate position and adhered well without obvious endoleak, while the distal bare stent was in an appropriate position and adhered well | immediately after the surgery |
| Endoleak rate | within 12 months after surgery |
| Secondary surgical treatment rate | Secondary endovascular or surgical treatment due to stent displacement, endoleak, or related complications after stent implantation | within 12 months after surgery |
| 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 |