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This is a prospective, multicenter and single-arm trail to study the safety and efficacy of the thoracic aortic stent graft system that specially designed for treating aortic dissection.
This trail is conducted in several centers all around China. In about 18 months, 120 subjects with aortic dissection will be recruited, all of which receive endovascular treatment using the thoracic aortic stent graft system (Zylox-Tonbridge Medical Technology Co., Ltd. ). The subjects will be followed up in 30 days/ 6 months/ 12 months/ 2-5 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects with aortic dissection | Other | Subjects receive endovascular treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The Thoracic Aortic Stent Graft System (Zylox-Tonbridge Medical Technology Co., Ltd. ) | Device | This is a objective performance criteria-controlled study, all subjects meet the criteria will receive the same treatment using the thoracic aortic stent graft system (Zylox-Tonbridge Medical Technology Co., Ltd. ). |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of no Major Adverse Event (MAE) | MAE was defined as aortic dissection related death, disabling stoke or paraplegic. | Immediately after the intervention |
| Rate of no Major Adverse Event (MAE) | MAE was defined as aortic dissection related death, disabling stoke or paraplegic. | 30 days |
| Success rate of endovascular treatment |
| Up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of aortic dissection related mortality | Death caused by aortic dissection rupture or related treatment. | Intraoperation/ 30 days/ 6 months/ 12 months/ up to 2-5 years |
| Rate of all cause mortality |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jie Liang | Contact | 13819565660 | jie.liang@zyloxmedical.com |
| Name | Affiliation | Role |
|---|---|---|
| Xinwu Lu | Shanghai Ninth People's Hostpital, Shanghai JiaoTong University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Bengbu medical College | Bengbu | Anhui | China |
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Death for any reason will be recorded.
| Intraoperation/ 30 days/ 6 months/ 12 months/ up to 2-5 years |
| Rate of Adverse Events(AE) | The definition of AE(Adverse Event) refers to International Organization for Standardization (ISO) 14155, AE should be distinguished from normal postoperative stress response. | Intraoperation/ 30 days/ 6 months/ 12 months/ up to 2-5 years |
| Rate of Serious Adverse Events(SAE) | The definition of SAE (Serious Adverse Event) refers to ISO 14155. | Intraoperation/ 30 days/ 6 months/ 12 months/ up to 2-5 years |
| Rate of technique success | The delivery system was successfully delivered to the predetermined position, the stent was accurately positioned and successfully deployed, and the delivery system could be safely withdrawn from the body, no type I or type III endoleak can be found during angiography. | Immediately after the intervention |
| Incidence of stent displacement | Stent displacement was defined as the aortic and branch stent-grafts displacing by more than 10 mm from the post-implantation position. | 30 days/ 6 months/ 12 months |
| Success rate of endovascular repair | Comparison of CTA results before surgery and within 30 days, 6 months, and 12 months after surgery. Changes in the diameter of the stent covered by aortic dissection and thrombosis of the false lumen are used to determine whether the vessel is successfully repaired. | 30 days/ 6 months/ 12 months |
| The Second Hospital Of Anhui Medical University | Hefei | Anhui | China |
| Liuzhou Worker's Hospital | Liuzhou | Guangxi | China |
|
| Huaihe Hospital of Henan University | Kaifeng | Henan | China |
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| The First Affiliated Hospital Of Zhengzhou University | Zhengzhou | Henan | China |
|
| Renmin Hospital Of Wuhan University | Wuhan | Hubei | China |
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| Nanjing Drum Tower Hospital, the affiliated Hospital of Nanjing University Medical School | Nanjing | Jiangsu | China |
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| The Second Affiliated Hospital Of Nanchang University | Nanchang | Jiangxi | China |
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| The First Affiliated Hospital of Xi'An Jiaotong University | Xi'an | Shaanxi | China |
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| The First Hospital Of Zhejiang Province | Hanzhou | Zhejiang | China |
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| The First Affiliated Hospital Of WMU | Wenzhou | Zhejiang | China |
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| Peking Union Medical College Hospital | Beijing | China |
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| Shanghai Ninth People's Hostpital, Shanghai JiaoTong University School of Medicine | Shanghai | China |
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| Zhongshan Hospital | Shanghai | China |
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| ID | Term |
|---|---|
| D000784 | Aortic Dissection |
| ID | Term |
|---|---|
| D000094665 | Dissection, Blood Vessel |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000094683 | Acute Aortic Syndrome |
| D001018 | Aortic Diseases |
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