Aortic Dissection Type B
Conditions
Brief summary
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.
Interventions
DEVICEFabulous Stent Graft System
All patients received endovascular surgery using fabulous stent graft system
Sponsors
Hangzhou Endonom Medtech Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 .
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with no incidence of major surgical or device related adverse events rate | within 30 days after surgery | 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 |
| Clinical success rate | 12 months after surgery | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immediate operation successful rate | immediately after the surgery | 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 |
| adverse event rate | within 12 months after surgery | — |
| Secondary surgical treatment rate | within 12 months after surgery | Secondary endovascular or surgical treatment due to stent displacement, endoleak, or related complications after stent implantation |
| Endoleak rate | within 12 months after surgery | — |
| Immediate delivery success rate | immediately after the surgery | The stent graft system was successfully transported to the correct position and released successfully |
Countries
China
Outcome results
None listed