Stanford Type A Aortic Dissection
Conditions
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >=18 years, male or female. 2. Within 90 days of onset of Stanford Type A Aortic Dissection and 30 days post Total Arch Replacement with Frozen Elephant Trunk treatment (assessed via CTA at 30+/-7 days post open surgery): a. Presence of any intimal tear in the residual dissection of the thoracic aorta and the false lumen is not completely thrombosed. b. The intercostal arteries in the segment of the residual thoracic aortic dissection are primarily supplied by the false lumen (number of intercostal arteries supplied by false/mixed lumen > number supplied by true lumen; only intercostal arteries filled with contrast agent are considered). c. False lumen volume in the thoracic aorta distal to the frozen elephant trunk stent graft is >50% of the total aortic lumen volume. 3. Voluntarily participate in this study and provide signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Presence of a proximal anastomotic leak at the frozen elephant trunk site post open surgery. 2..No left subclavian artery revascularization during the open surgery. 3. Presence of severe endoleak, or residual dissection expansion =55mm, or distal stent graft-induced new entry. 4. History of myocardial infarction, or stroke (with clear symptoms/signs and culprit lesion), or bowel ischemia within 1 month prior to the procedure. 5. Previous history of descending thoracic or abdominal aortic surgery. 6. Lack of suitable vascular access. 7. Known allergy to components of the study device (e.g., Nitinol) or contrast agent. 8. Renal insufficiency (creatinine >2.5 times the upper limit of normal) or requiring long-term regular dialysis. 9. Severe liver dysfunction (Child-Pugh Class C). 10. Active bleeding, coagulation disorders, thrombocytopenia (platelet count <50×10^9/L), or refusal of blood transfusion. 11. Uncontrolled severe infection and associated sepsis, shock, or multiple organ failure. 12. Life expectancy less than 12 months (due to conditions other than aortic dissection). 13. Known or suspected connective tissue degenerative disease, or family history of aortic dissection. 14. Pregnant or lactating women. 15. Concurrent participation in other drug or medical device clinical studies. 16. Subjects deemed unsuitable for participating the study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in False Lumen Volume of the Distal Aortic Dissection at 12 months;Incidence of Major Adverse Events (MAEs) within 30 days; | — |
Secondary
| Measure | Time frame |
|---|---|
| Procedure Success Rate (Study Group only);Treatment Success Rate (Study Group only);Change in True Lumen Volume of the Distal Aortic Dissection ;Change in False Lumen Volume of the Distal Aortic Dissection ;Change in Maximum Diameter of the Distal Aorta (True + False Lumen) ;Thrombosis Status of the False Lumen in the Distal Aortic Dissection ;Rate of Secondary Intervention Related to the Distal Aortic Dissection ;Survival Rate (key secondary safety endpoint);Incidence of MAEs ();Incidence of Paraplegia/Spinal Cord Ischemia ;Incidence of Acute Kidney Injury (AKI) ;Incidence of Stroke ;Incidence of Stent Migration (Study Group only);Incidence of Adverse Events (AEs) / Serious Adverse Events (SAEs);Incidence of Device Deficiencies (Study Group only); | — |
Countries
China
Contacts
Public ContactJia Hu
West China Hospital of Sichuan University
Outcome results
None listed