Stanford type A aortic dissection, intramural hematoma (IMH) and penetrating ulcer (PAU) in the ascending aorta
Conditions
Interventions
Single group clinical study:Treatment of Stanford type A aortic dissection with a total endovascular reconstruction system
Sponsors
Guangdong Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Patients diagnosed with Stanford type A aortic dissection or intramural hematoma (IMH) or penetrating ulcer (PAU) of the ascending aorta and meeting one of the following conditions: a. Age = 70 years old, refuses to undergo thoracotomy, and has been evaluated by two or more cardiac team doctors for high-risk surgical procedures; b. Age = 60 and<70 years old, with high surgical risk assessed by two or more cardiac team doctors; c. Age = 18 years old and<60 years old, evaluated by two or more cardiac team doctors as relatively contraindicated for surgical procedures; 2. Suitable aortic dissection conditions [ascending aortic length (centerline) = 50mm; aortic diameter 24mm-49mm]; 3. If there is a rupture, the first rupture position should be = 10mm away from the coronary artery (aortic valve); 4. Having a suitable vascular approach allows for endovascular treatment of the aorta; 5. Able to understand the purpose of the experiment, voluntarily participate in this study, and the subjects themselves or their guardians sign an informed consent form, willing to complete follow-up according to the protocol requirements.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating patients; 2. Those who have not reached the main endpoint in clinical trials of other drugs or devices; 3. Patients who have previously placed covered stents at the same surgical site; 4. Patients who are known to be allergic to contrast agents, anesthetics, stents, and conveyor materials; 5. Patients with contraindications to antiplatelet and anticoagulant drugs; 6. Patients with severe liver dysfunction (Child Pugh C grade) before surgery; 7. It is known that there are blood system diseases and anemia hemoglobin is below 60g/L. Patients with severe coagulation dysfunction or bleeding tendency (platelet count less than 40 * 109/L); 8. Patients with paraplegia or in a coma state; 9. Life expectancy is less than 12 months (such as advanced malignant tumors); 10. Acute systemic infection; 11. Other situations where the researcher determines that it is not suitable to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical success rate at 12 months after surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| All cause mortality rate;Severe stroke incidence rate;Serious adverse event occurrence rate;Incidence rate of device related adverse events and serious adverse events;Device implantation success rate;The incidence of type I or III internal leakage;Incidence of displacement of covered stents;Vascular remodeling in aortic dissection;The incidence of secondary surgical intervention;The incidence of major adverse events (MAEs) at 30 days after surgery; | — |
Countries
China
Contacts
Public ContactFan Ruixin/ Luo Jianfang
Guangdong Provincial People's Hospital
Outcome results
None listed