Aortic dilatation disease
Conditions
Interventions
Experimental group:The aortic covered stent system combined with the aortic covered stent rupture system is used to treat diseases of aortic arch dilation.
Sponsors
Peking University People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18 - 80 years old, gender not restricted; 2. Diseases requiring intervention involving the aortic arch dilation; 3. Patients requiring single, double or triple branch blood circulation reconstruction in the arch area; 4. Reference vessel diameter in the anchoring area: 22mm - 42mm; 5. Have a suitable vascular access for endovascular aortic treatment; 6. Can understand the purpose of the trial, voluntarily participate in this study, and the subject or the guardian signs the informed consent form, willing to complete the follow-up as per the protocol requirements.
Exclusion criteria
Exclusion criteria: 1. Complicated with abdominal aortic aneurysm that requires concurrent surgical treatment; 2. Patients with ruptured or infected aortic aneurysms; 3. Patients with severe thrombus in the anchoring area or those whose stent grafts are prone to fail to adhere or affect the patency of the stent due to such conditions; 4. Those who have undergone endovascular aortic repair at the same surgical site before; 5. Acute aortic rupture; 6. Severe tortuosity or diffuse stenosis of the iliac and femoral arteries, which may cause obstruction in the introduction of the guiding sheath; 7. Those who have undergone aortic surgery in the arch region within 1 month before enrollment, except for the surgery of implanting artificial blood vessels to establish the access pathway; 8. Those who had a history of myocardial infarction or stroke within 6 weeks before enrollment; 9. Pregnant or lactating patients or those who cannot prevent pregnancy during the trial; 10. Participants in other clinical trials of drugs or devices who did not reach the primary endpoint; 11. Patients known to be allergic to the materials of stents and delivery devices; 12. Patients with contraindications to antiplatelet drugs and anticoagulant drugs; 13. Severe renal dysfunction: patients with preoperative creatinine > 2.5 times the upper limit of normal; 14. Severe liver dysfunction: patients with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 times the upper limit of normal, or serum total bilirubin (STB) > 2 times the upper limit of normal; 15. Severe anemia (hemoglobin lower than 60g/L), or patients with bleeding tendency (platelet count less than 40*109/L); 16. Paraplegia or in a coma state; 17. Expected lifespan less than 12 months (such as advanced malignant tumors); 18. Acute systemic infections, patients with Marfan syndrome (or other connective tissue diseases); 19. Other conditions determined by the investigator as not suitable for participating in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The treatment success rate 12 months after the surgery;There were no major adverse events one month after the surgery.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Success rate of device implantation;Instantaneous technical success rate;Test instrument micropore closure rate;The incidence of internal leakage;The incidence of aortic endovascular stent graft displacement;The incidence of secondary intervention;The maximum diameter and diameter change of the aortic lesion;The rate of complete thrombosis of the false cavity / tumor cavity;Proportion of patent branch vessels; | — |
Countries
China
Contacts
Public ContactWei Li
Peking University People's Hospital
Outcome results
None listed