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 range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Rate of reintervention on the aortic arch or descending aorta
. 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.
. Pregnancy or lactation.
. Severe psychiatric or cognitive disorders affecting compliance or follow-up.