Dissection and/or aneurysm involving the distal end of the aortic arch
Conditions
Interventions
Single group clinical study:surgical treatment
Sponsors
Gaozhou People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. = 18 years old; 2. After the operation of aortic disease, the researcher believes that the dissection and/or aneurysm at the distal end of the aorta still need to be interfered with; 3. Appropriate aortic anatomy conditions (the researcher estimated the diameter of the aorta before the lesion to be 20 mm-46 mm); 4. With appropriate vascular approach, endovascular treatment can be performed; 5. Be able to understand the purpose of the trial, voluntarily participate in the study, and the subject himself or her guardian signs the informed consent, and is willing to complete the follow-up according to the protocol requirements.
Exclusion criteria
Exclusion criteria: 1. Patients who are unable to use contraception during pregnancy or lactation or test; 2. Those who participate in clinical trials of other drugs or devices and fail to reach the main end point; 3. Patients who are known to be allergic to contrast agents, anesthetic drugs, stents and materials of the transporter; 4. Patients with antiplatelet and anticoagulant contraindications; 5. Patients with severe liver dysfunction (Child-Pugh C) before operation; 6. Patients with severe renal dysfunction (CKD stage 5) before operation; 7. Patients with severe coagulation insufficiency or bleeding tendency (platelet count less than 40 * 109/L); 8. Blood system disease, anemia hemoglobin lower than 60g/L; 9. Life expectancy is less than 12 months (such as advanced malignant tumor); 10. Acute systemic infection; 11. Patients with severe cardiopulmonary insufficiency (LVEF < 35%) or (blood oxygen saturation < 90%) or poor physical condition who cannot tolerate interventional surgery; 12. Other conditions determined by the researcher to be unsuitable for the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Operation success rate 30 days after operation; | — |
Secondary
| Measure | Time frame |
|---|---|
| 30-day all-cause mortality;Incidence of serious adverse events 30 days after operation;Incidence of device-related adverse events 30 days after operation;Device implantation success rate;Incidence of type I or III internal leakage 30 days after operation;Incidence of covered stent displacement 30 days after operation;Vascular remodeling of aortic dissection 30 days after operation;Incidence of secondary surgical intervention 30 days after operation; | — |
Countries
China
Contacts
Public ContactCao Yong
Gaozhou People's Hospital
Outcome results
None listed