Aortic arch aneurysm
Conditions
Interventions
Sponsors
The First Medical Center of the PLA General Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients aged 18 to 80 years old; 2. Diagnosed with aortic arch lesions requiring intervention, including true aortic arch aneurysms, pseudo-aortic arch aneurysms, and ulcers involving the aortic arch; 3. Showing a suitable vascular condition, including: Ascending aorta length greater than 50 mm (from the aortic sinusoid junction to the proximal cardiac margin of the innominate artery). Ascending aorta diameter >= 24 mm and = 30 mm; Innominate artery diameter = 7 mm, length >= 20 mm; Left common carotid artery or left subclavian artery diameter = 7 mm, length >= 20 mm; Suitable arterial access for endovascular interventional treatment; 4. Able to understand the purpose of the trial, participate in the trial voluntarily with informed consent form signed by the patient him/herself or his or her legal representative, and willing to complete follow-up visits as required under the protocol. 5. Evaluated by at least two vascular surgeons or cardiac surgeons as high surgical risk patients or deemed to have significant surgical contraindications.
Exclusion criteria
Exclusion criteria: 1. Experienced systemic infection during past three months; 2. Neck surgery was performed within 3 months; 3. Previous endovascular interventional treatment involving the aortic arch was performed; 4. Infectious aortic diseaseTakayasu arteritisMarfan syndrome (or other connective tissue diseases); 5. Severe stenosis, calcification, thrombosis, or tortuosity of the carotid or subclavian artery; 6. Heart transplant; 7. Suffered MI or stroke during past three months; 8. Class IV heart function (NYHA classification); 9. Active peptic ulcers or upper gastrointestinal bleeding occurring within the previous three months; 10. Hematological abnormality, defined as follows: Leukopenia (WBC 265 umol/L (or 3.0mg/dL) and/or end-stage renal disease requiring renal dialysis, as determined by an investigator after a thorough analysis; 12. Pregnant or breastfeeding; 13. Allergies to contrast agents; 14. Life expectancy of less than 12 months; 15. Participating in another drug or device research; 16. Any other disease or abnormality that the investigators believe may hinder endovascular interventional treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All-cause mortality and major stroke within 12 months after surgery. All-cause mortality includes cardiac mortality, non-cardiac mortality, and mortality from unknown causes. Severe stroke is defined as a modified Rankin score (mRS) = 2 at 90 days following stroke onset.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Immediate technical success following surgery.;Aortic aneurysm progression under control 12-month after operation.;Incidence of Type I or Type III endoleak before discharge, 1 month, 6 months, 12 months after operation.;Incidence of aortic arch stent graft displacement 1 month, 6 months, 12 months after operation 1 month, 6 months, 12 months after operation.;Postoperative branch vessel patency rate 1 month, 6 months, 12 months after operation.;Incidence of surgically induced de novo aortic dissection converted to open-heart surgery or secondary intervention 30 days, 6 months, and 12 months after operation.;Major adverse events occurring within 30 days after surgery.; | — |
Countries
China
Contacts
Public ContactXia Shengnan
Hangzhou Weiqiang Medical Technology Co., Ltd.
Outcome results
None listed