Aortic Dissection Type B Clinical Trial
Official title:
Safety and Efficacy Study of Fabulous Stent Graft System for Stanford B Aortic Dissection: A Prospective, Multi-center, Single Arm, Objective Performance Criteria Clinical Trial
Verified date | November 2021 |
Source | Hangzhou Endonom Medtech Co., Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 148 |
Est. completion date | October 13, 2020 |
Est. primary completion date | October 13, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Patients =18 years old; 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: 1. The patient's distal vascular false cavity has been completely thrombotic or organized; 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 . |
Country | Name | City | State |
---|---|---|---|
China | 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 |
Lead Sponsor | Collaborator |
---|---|
Hangzhou Endonom Medtech Co., Ltd. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Secondary | adverse event rate | within 12 months after surgery | ||
Secondary | Immediate delivery success rate | The stent graft system was successfully transported to the correct position and released successfully | immediately after the surgery | |
Secondary | 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 | |
Secondary | Endoleak rate | within 12 months after surgery | ||
Secondary | 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 |
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