AAR/AAR+HAR vs AAR+TAR+FET for Type A Aortic Intramural Hematoma (NCT07272655) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
AAR/AAR+HAR vs AAR+TAR+FET for Type A Aortic Intramural Hematoma
400 participantsStarted 2026-06-01
Plain-language 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, major adverse cardiovascular events, other perioperative complications, and total hospitalization cost. A total of 400 participants will be enrolled.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.
✕. Severe peripheral vascular disease or cerebrovascular anatomy abnormality.
✕. Active systemic infection, malignancy, severe hepatic or renal dysfunction, or other major comorbidities with life expectancy \< 1 year or deemed unfit for complex cardiovascular surgery.
What they're measuring
1
Rate of reintervention on the aortic arch or descending aorta