Aortic Intramural HematomaNCT07272655
AAR/AAR+HAR vs AAR+TAR+FET for Type A Aortic Intramural Hematoma
A study testing Ascending Aorta Replacement / Ascending Aorta Plus Hemiarch Replacement and Ascending Aorta Replacement With Total Arch Replacement and Frozen Elephant Trunk in people with Aortic Intramural Hematoma, run by Second Hospital of Jilin University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Aortic Intramural Hematoma
- What is being tested?
- Ascending Aorta Replacement / Ascending Aorta Plus Hemiarch Replacement and Ascending Aorta Replacement With Total Arch Replacement and Frozen Elephant Trunk
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 30 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- Pregnancy or lactation.
- Severe psychiatric or cognitive disorders affecting compliance or follow-up.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Prospective, Randomized, Non-Inferiority Trial of AAR/AAR+HAR Versus AAR+TAR+FET in Type A Aortic Intramural Hematoma
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.
Read the detailed description
This is a prospective, randomized, controlled, non-inferiority study comparing two surgical strategies for acute type A aortic intramural hematoma (TAIMH). Patients with acute TAIMH will be screened and enrolled based on CTA confirmation of a completely thrombosed false lumen in the ascending aorta and aortic arch. Participants will be randomly assigned in a 1:1 ratio to receive either AAR/AAR+HAR or AAR+TAR+FET, with 200 participants in each group. Postoperative CTA will be performed before discharge, and follow-up CTA will be performed at 6 to 12 months after surgery.
The surgical procedure will be performed through a median sternotomy or upper partial sternotomy. Cardiopulmonary bypass will be established through right axillary/femoral arterial and bicaval venous cannulation, or femoral arteriovenous cannulation and superior vena cava cannulation. Left ventricular venting will be achieved via the right superior pulmonary vein. Antegrade HTK or cold blood cardioplegia will be administered under direct vision and repeated every 30 minutes. During circulatory arrest, bilateral selective antegrade cerebral perfusion will be provided via the right axillary artery and left common carotid artery.
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. The trial is designed to test whether the less extensive AAR/AAR+HAR strategy is non-inferior to AAR+TAR+FET with respect to the primary endpoint, while potentially offering advantages in operative burden, perioperative safety, and hospitalization cost.
- Conditions
- Aortic Intramural Hematoma
- Being tested
- Ascending Aorta Replacement / Ascending Aorta Plus Hemiarch Replacement, Ascending Aorta Replacement With Total Arch Replacement and Frozen Elephant Trunk
- Keywords
- Aortic Intramural Hematoma, Type A, Hemiarch Replacement, Total Arch Replacement, Non-Inferiority Trial
- Medical subject headings
- Aortic Intramural Hematoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ascending Aorta Replacement / Ascending Aorta Plus Hemiarch ReplacementProcedure or surgery
Also called AAR/AAR+HAR
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 TrunkProcedure or surgery
Also called AAR+TAR+FET
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.
| Study group | Role | What they receive |
|---|---|---|
| AAR/AAR+HAR Group | Experimental | Participants randomized to this group will undergo ascending aorta replacement alone or ascending aorta plus hemiarch replacement (AAR/AAR+HAR), according to the operative strategy. This procedure involves replacing the ascending aorta with or without replacement of the proximal aortic arch while preserving the distal arch and supra-aortic vessels. Receives: Procedure: Ascending Aorta Replacement / Ascending Aorta Plus Hemiarch Replacement |
| AAR+TAR+FET Group | Active comparator | Participants randomized to this group will undergo ascending aorta replacement with total arch replacement and frozen elephant trunk implantation (AAR+TAR+FET). This procedure involves replacement of the entire aortic arch combined with frozen elephant trunk repair of the proximal descending aorta. Receives: Procedure: Ascending Aorta Replacement With Total Arch Replacement and Frozen Elephant Trunk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of reintervention on the aortic arch or descending aorta
The proportion of patients requiring any secondary surgical or endovascular procedure involving the aortic arch or descending aorta during follow-up after the index operation.
Measured: 6 to 12 months after surgery
Secondary outcomes (5)
Aortic Cross-Clamp Time
Duration (minutes) of aortic cross-clamping during surgery.
Measured: Intraoperative
Circulatory Arrest Time
Duration (minutes) of total circulatory arrest.
Measured: Intraoperative
Major Adverse Cardiovascular Events (MACE)
Incidence of major adverse cardiovascular events during the perioperative period. The exact components should follow the study protocol and statistical analysis plan.
Measured: Through 30 days after surgery
Other perioperative complications
Incidence of perioperative complications during the perioperative period, including but not limited to neurological events, renal dysfunction, infection, bleeding, and cardiac failure.
Measured: Through 30 days after surgery
Total hospitalization cost
The total direct medical cost incurred during the index hospitalization, including surgery, intensive care, ward stay, medications, blood products, imaging, laboratory tests, procedures, and other treatment-related in-hospital expenses.
Measured: Through hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start1 Oct 2026 (estimated)
- Primary completion30 Oct 2027 (estimated)
- Study completion30 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Intramural HematomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective, randomized, parallel-group, non-inferiority trial. Participants with acute type A aortic intramural hematoma will be assigned in a 1:1 ratio to receive either ascending aorta replacement/ascending aorta plus hemiarch replacement (AAR/AAR+HAR) or ascending aorta replacement with total arch replacement and frozen elephant trunk (AAR+TAR+FET). A total of 400 participants will be enrolled.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kexiang Liu, MD, Second Hospital of Jilin University
- Investigators
- kexiang Liu, Ph.D., Principal investigator, Department of Cardiovascular Surgery, The Second Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07272655
- Sponsor's protocol ID
- JDEY-TAIMH
- Status last verified
- Aug 2026
- First submitted
- 26 Nov 2025
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) that underlie the results reported in the published article will be shared. This includes baseline demographic data, clinical characteristics, operative details, and all primary and secondary outcome measures collected during the study. Additionally, the study protocol, statistical analysis plan (SAP), and clinical study report (CSR) will be made available to provide context for the data.
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Non-Inferiority Trial of AAR/AAR+HAR Versus AAR+TAR+FET in Type A Aortic Intramural Hematoma
- ClinicalTrials.gov ID
- NCT07272655
- Acronym / sponsor ID
- JDEY-TAIMH
- Conditions
- Aortic Intramural Hematoma
- Keywords
- Aortic Intramural Hematoma, Type A, Hemiarch Replacement, Total Arch Replacement, Non-Inferiority Trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Second Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 30 Oct 2027 (estimated)
- Study completion
- 30 Oct 2027 (estimated)
- First posted
- 9 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a prospective, randomized, controlled, non-inferiority study comparing two surgical strategies for acute type A aortic intramural hematoma (TAIMH). Patients with acute TAIMH will be screened and enrolled based on CTA confirmation of a completely thrombosed false lumen in the ascending aorta and aortic arch. Participants will be randomly assigned in a 1:1 ratio to receive either AAR/AAR+HAR or AAR+TAR+FET, with 200 participants in each group. Postoperative CTA will be performed before discharge, and follow-up CTA will be performed at 6 to 12 months after surgery.
The surgical procedure will be performed through a median sternotomy or upper partial sternotomy. Cardiopulmonary bypass will be established through right axillary/femoral arterial and bicaval venous cannulation, or femoral arteriovenous cannulation and superior vena cava cannulation. Left ventricular venting will be achieved via the right superior pulmonary vein. Antegrade HTK or cold blood cardioplegia will be administered under direct vision and repeated every 30 minutes. During circulatory arrest, bilateral selective antegrade cerebral perfusion will be provided via the right axillary artery and left common carotid artery.
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. The trial is designed to test whether the less extensive AAR/AAR+HAR strategy is non-inferior to AAR+TAR+FET with respect to the primary endpoint, while potentially offering advantages in operative burden, perioperative safety, and hospitalization cost.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a prospective, randomized, parallel-group, non-inferiority trial. Participants with acute type A aortic intramural hematoma will be assigned in a 1:1 ratio to receive either ascending aorta replacement/ascending aorta plus hemiarch replacement (AAR/AAR+HAR) or ascending aorta replacement with total arch replacement and frozen elephant trunk (AAR+TAR+FET). A total of 400 participants will be enrolled.
| Arm | Type | Receives |
|---|---|---|
| AAR/AAR+HAR Group | Experimental | Procedure: Ascending Aorta Replacement / Ascending Aorta Plus Hemiarch ReplacementParticipants randomized to this group will undergo ascending aorta replacement alone or ascending aorta plus hemiarch replacement (AAR/AAR+HAR), according to the operative strategy. This procedure involves replacing the ascending aorta with or without replacement of the proximal aortic arch while preserving the distal arch and supra-aortic vessels. |
| AAR+TAR+FET Group | Active comparator | Procedure: Ascending Aorta Replacement With Total Arch Replacement and Frozen Elephant TrunkParticipants randomized to this group will undergo ascending aorta replacement with total arch replacement and frozen elephant trunk implantation (AAR+TAR+FET). This procedure involves replacement of the entire aortic arch combined with frozen elephant trunk repair of the proximal descending aorta. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ascending Aorta Replacement / Ascending Aorta Plus Hemiarch ReplacementAlso: AAR/AAR+HARThis 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. | Procedure or surgery | AAR/AAR+HAR Group |
| Ascending Aorta Replacement With Total Arch Replacement and Frozen Elephant TrunkAlso: AAR+TAR+FETThis 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. | Procedure or surgery | AAR+TAR+FET Group |
Primary outcome
Rate of reintervention on the aortic arch or descending aorta
Time frame: 6 to 12 months after surgery
The proportion of patients requiring any secondary surgical or endovascular procedure involving the aortic arch or descending aorta during follow-up after the index operation.
5 secondary outcomes
Aortic Cross-Clamp Time
Time frame: Intraoperative
Circulatory Arrest Time
Time frame: Intraoperative
Major Adverse Cardiovascular Events (MACE)
Time frame: Through 30 days after surgery
Other perioperative complications
Time frame: Through 30 days after surgery
Total hospitalization cost
Time frame: Through hospital discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) that underlie the results reported in the published article will be shared. This includes baseline demographic data, clinical characteristics, operative details, and all primary and secondary outcome measures collected during the study. Additionally, the study protocol, statistical analysis plan (SAP), and clinical study report (CSR) will be made available to provide context for the data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
kexiang Liu, Ph.D. principal investigator
Department of Cardiovascular Surgery, The Second Hospital of Jilin University
Questions about this trial
What is this clinical trial studying?
A study testing Ascending Aorta Replacement / Ascending Aorta Plus Hemiarch Replacement and Ascending Aorta Replacement With Total Arch Replacement and Frozen Elephant Trunk in people with Aortic Intramural Hematoma, run by Second Hospital of Jilin University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact kexiang liu, MD，Ph.D. (17390920328, kxliu64@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of reintervention on the aortic arch or descending aorta (time frame: 6 to 12 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.