Safety and Efficacy Study of Fabulous Stent Graft System for Stanford B Aortic Dissection

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Aortic Dissection Type B

Intervention / Treatment
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* Device: Fabulous Stent Graft System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients ≥18 years old; The informed consent was signed by the patient or the legal representative; Diagnosed with Stanford B aortic dissection; The proximal anchoring area of is 18-42 mm in diameter, and not less than 15mm in length; Has a suitable arterial approach and is suitable for surgical treatment. Exclusion Criteria: The patient's distal vascular false cavity has been completely thrombotic or organized; Pregnant or breastfeeding ; Has participated in clinical trials of other devices ； History of aortic surgery or endovascular repair surgery ; Allergic to contrast agents and anesthetics ; Allergic to stents or conveyors ; Patients with true or false aortic aneurysm; History of myocardial infarction, TIA or cerebral infarction within the past 3 months; Life expectancy is less than 12 months; Other situations in which the investigator judges that not suitable for endovascular treatment .

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fabulous Stent Graft System<br>All patients received endovascular surgery using fabulous stent graft system | Device: Fabulous Stent Graft System<br>* All patients received endovascular surgery using fabulous stent graft system<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |