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AAR/AAR+HAR vs AAR+TAR+FET for Type A Aortic Intramural Hematoma
Sponsor: Second Hospital of Jilin University
Summary
This is a prospective, randomized, non-inferiority clinical trial designed to compare the efficacy and safety of two surgical strategies for acute type A aortic intramural hematoma (TAIMH): (1) ascending aorta replacement or ascending aorta plus hemiarch replacement (AAR/AAR+HAR), and (2) ascending aorta replacement with total arch replacement and frozen elephant trunk implantation (AAR+TAR+FET). Patients will be enrolled based on CTA confirmation of a completely thrombosed false lumen in the ascending aorta and aortic arch. Eligible participants will be randomized in a 1:1 ratio to either group. The primary endpoint is the rate of reintervention on the aortic arch or descending aorta from 6 to 12 months after surgery. Secondary endpoints include circulatory arrest time, aortic cross-clamp time, operation time, major adverse cardiovascular events, other perioperative complications, and total hospitalization cost. A total of 400 participants will be enrolled.
Official title: A Prospective, Randomized, Non-Inferiority Trial of AAR/AAR+HAR Versus AAR+TAR+FET in Type A Aortic Intramural Hematoma
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
400
Start Date
2026-04-01
Completion Date
2027-10-30
Last Updated
2026-04-09
Healthy Volunteers
No
Conditions
Interventions
Ascending Aorta Replacement / Ascending Aorta Plus Hemiarch Replacement
This procedure involves ascending aorta replacement alone or ascending aorta plus hemiarch replacement, according to the operative strategy. The ascending aorta is replaced with or without replacement of the proximal aortic arch, while the distal arch and supra-aortic vessels are preserved.
Ascending Aorta Replacement With Total Arch Replacement and Frozen Elephant Trunk
This procedure involves ascending aorta replacement with total arch replacement and frozen elephant trunk implantation. The entire aortic arch is replaced, and a frozen elephant trunk is implanted into the proximal descending aorta.