Heart surgery showdown: which fix for aortic hematoma works best?
NCT ID NCT07272655
First seen Jun 27, 2026 · Last updated Aug 14, 2026 · Updated 2 times
Summary
This study compares two surgical strategies for a serious condition called type A aortic intramural hematoma, where bleeding occurs within the aortic wall. About 400 adults will be randomly assigned to receive either a less extensive repair (ascending aorta replacement with or without hemiarch replacement) or a more extensive repair (ascending aorta replacement plus total arch replacement with frozen elephant trunk). The main goal is to see which approach reduces the need for additional procedures on the aorta within 6 to 12 months after surgery.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 400 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Oct 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age ≥ 18 years and ≤ 80 years. 2. Diagnosis of type A aortic intramural hematoma (TAIMH). 3. Ability to understand the study procedure and provide written informed consent. Exclusion Criteria: 1. Preoperative CTA shows an open or partially thrombosed (mixed) false lumen in the ascending aorta or arch. 2. Primary tear located on the greater curvature of the aortic arch, necessitating total arch replacement. 3. Planned concomitant major cardiac surgery (e.g., CABG, valve replacement, atrial fibrillation ablation). 4. Previous history of aortic arch or distal aortic surgery. 5. Severe peripheral vascular disease or cerebrovascular anatomy abnormality. 6. 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. 7. Pregnancy or lactation. 8. Severe psychiatric or cognitive disorders affecting compliance or follow-up.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
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The official record
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