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

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

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.

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 .