Aortic intramural hematoma
Conditions
Interventions
TEVAR and the best pharmacotherapy group:TEVAR in combination with optimal medical therapy
Best pharmacological treatment group:Optimal medical treatment
Sponsors
Zhongshan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Simultaneously satisfying: 1. Age >= 18 years old; 2. IMH thickness>5mm; 3. At the onset of the disease, the hemodynamics were stable and there were no indications for emergency surgery; 4. Signed informed consent form; 5. Acute onset <= 14 days, diagnosed as unstable Stanford B-type IMH; Unstable IMH is defined as meeting any of the following criteria: 1. Uncontrollable hypertension; 2. Pain cannot be completely relieved or recurs repeatedly; 3. Initial or new FID or ULP, depth <= 10mm and length <= 20mm; 4. Merge pleural effusion; 5. Imaging manifestations of poor perfusion without clinical symptoms or abnormal blood indicators; 6. Continuous CTA indicates an increase in IMH thickness, with a maximum thickness of <= 13mm; 7. Continuous CTA indicates an increase in aortic diameter, with a maximum diameter of <= 45mm.
Exclusion criteria
Exclusion criteria: 1. First onset CTA suggests involvement of the ascending aorta; 2. At the initial diagnosis, the hemodynamics were unstable and required emergency surgical intervention; 3. At the onset of the disease, CTA indicates IMH thickness>13mm or maximum aortic diameter>45mm or FID, ULP depth>10mm or length>20mm; 4. Combined connective tissue diseases, such as Marfan syndrome; 5. Rheumatoid immune system lesions involving the aorta; 6. Previously received aortic stent graft implantation for aortic disease; 7. Combined severe heart, lung, and liver failure; 8. Severe renal failure (creatinine>250umol/L), non dialysis status; 9. History of malignant tumors and active stage; 10. Life expectancy is less than 1 year; 11. Inability to complete or tolerate CTA examination during follow-up due to factors such as contrast agent allergy; 12. Long term oral administration of anticoagulants such as warfarin is required due to other illnesses; 13. Women of childbearing age, pregnant or lactating women who have a negative pregnancy test but refuse to take effective contraceptive measures; 14. Have participated in or are currently undergoing drug or device clinical trials within the past 30 days; 15. Has had serious drug or alcohol abuse in the past year; 16. Due to mental illness, cognitive or emotional disorders that prevent understanding or compliance with the study, the researcher deems it inappropriate to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Any aortic adverse events within 30 days and 1 year; | — |
Secondary
| Measure | Time frame |
|---|---|
| Death due to all causes within 30 days and 1 year;Aortic related deaths within 30 days and 1 year;CT imaging results;Complications related to TEVAR within 30 days and 1 year, including SINE, internal leakage, paraplegia, stroke, and vascular access complications; | — |
Countries
China
Contacts
Public ContactZhihui Dong
Zhongshan Hospital, Fudan University
Outcome results
None listed