Safety and Efficacy Study Of The Thoracic Aortic Stent Graft System Treating Aortic Dissection

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
A Prospective, Multicenter, Objective Performance Criteria-Controlled Study for National Medical Products Administration Approval Of The Thoracic Aortic Stent Graft System

Conditions
-----------------
Aortic Dissection

Intervention / Treatment
-----------------
* Device: The Thoracic Aortic Stent Graft System (Zylox-Tonbridge Medical Technology Co., Ltd. )


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 to 80 years; Subject or legal representative is able to understand the purpose of study, agrees to comply with protocol requirements and has provided written informed consent； Subjects who are diagnosed with Stanford type B aortic dissection requiring reconstruction of the left common carotid artery and left subclavian artery or requiring reconstruction of the left subclavian artery; Appropriate access to the femoral artery, iliac artery, brachial artery, etc. that can be used for endoluminal aortic therapy. Exclusion Criteria: The same surgery requires intervention for other vascular lesions； History of surgery in the aortic arch or endovascular repair surgery; Severe stenosis or calcification or distortion in the anchoring area of the proximal end of the stent; Subjects with severe liver, kidney failure； Subjects with severe coagulation disorders； Female subjects who are pregnant, lactating within the study period or unable to contraception during the trail. History of allergies to anesthetics, contrast agents or the material of stent/ deliver system； Inability to tolerate anesthesia； History of acute myocardial infarction, cerebral infarction or cerebral hemorrhage within 3 months before surgery; Subjects who have participated in any other drug or medical device clinical investigations and haven't reach the primary endpoint. Subjects with acute systemic infection Other circumstances judged by researchers that are not suitable for enrollment .

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Subjects with aortic dissection<br>Subjects receive endovascular treatment. | Device: The Thoracic Aortic Stent Graft System (Zylox-Tonbridge Medical Technology Co., Ltd. )<br>* 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. ).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 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. | Up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Aortic Dissection, Thoracic aortic, Stent graft