About this trial
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, major adverse cardiovascular events, other perioperative complications, and total hospitalization cost. A total of 400 participants will be enrolled.
Eligibility criteria
Qualifiers
Age ≥ 18 years and ≤ 80 years.
Diagnosis of type A aortic intramural hematoma (TAIMH).
Ability to understand the study procedure and provide written informed consent.
Disqualifiers
Preoperative CTA shows an open or partially thrombosed (mixed) false lumen in the ascending aorta or arch.
Primary tear located on the greater curvature of the aortic arch, necessitating total arch replacement.
Planned concomitant major cardiac surgery (e.g., CABG, valve replacement, atrial fibrillation ablation).
Previous history of aortic arch or distal aortic surgery.
Trial design
Treatments tested in this trial
- Ascending Aorta Replacement / Ascending Aorta Plus Hemiarch Replacement
- Ascending Aorta Replacement With Total Arch Replacement and Frozen Elephant Trunk