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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
120
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. ).
The First Affiliated Hospital of Bengbu medical College
Bengbu, Anhui, China
The Second Hospital Of Anhui Medical University
Hefei, Anhui, China
Liuzhou Worker's Hospital
Rate of no Major Adverse Event (MAE)
MAE was defined as aortic dissection related death, disabling stoke or paraplegic.
Time frame: Immediately after the intervention
Rate of no Major Adverse Event (MAE)
MAE was defined as aortic dissection related death, disabling stoke or paraplegic.
Time frame: 30 days
Success rate of endovascular treatment
* 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position, the stent was accurately positioned and successfully deployed, and the delivery system could be safely withdrawn from the body, no type I or type III endoleak can be found during angiography. * No stent displacement during 12 months follow up time. * No secondary surgical intervention during 12 months follow up.
Time frame: Up to 12 months
Rate of aortic dissection related mortality
Death caused by aortic dissection rupture or related treatment.
Time frame: Intraoperation/ 30 days/ 6 months/ 12 months/ up to 2-5 years
Rate of all cause mortality
Death for any reason will be recorded.
Time frame: 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.
Time frame: Intraoperation/ 30 days/ 6 months/ 12 months/ up to 2-5 years
Rate of Serious Adverse Events(SAE)
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Liuzhou, Guangxi, China
Huaihe Hospital of Henan University
Kaifeng, Henan, China
The First Affiliated Hospital Of Zhengzhou University
Zhengzhou, Henan, China
Renmin Hospital Of Wuhan University
Wuhan, Hubei, China
Nanjing Drum Tower Hospital, the affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
The Second Affiliated Hospital Of Nanchang University
Nanchang, Jiangxi, China
The First Affiliated Hospital of Xi'An Jiaotong University
Xi'an, Shaanxi, China
The First Hospital Of Zhejiang Province
Hanzhou, Zhejiang, China
...and 4 more locations
The definition of SAE (Serious Adverse Event) refers to ISO 14155.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 30 days/ 6 months/ 12 months