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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ascending Aorta Replacement / Ascending Aorta Plus Hemiarch Replacement | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 to 12 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Aortic Cross-Clamp Time | Duration (minutes) of aortic cross-clamping during surgery. | Intraoperative |
| Circulatory Arrest Time | Duration (minutes) of total circulatory arrest. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| kexiang liu, MD,Ph.D. | Contact | 17390920328 | kxliu64@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| kexiang Liu, Ph.D. | Department of Cardiovascular Surgery, The Second Hospital of Jilin University | Principal Investigator |
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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.
Beginning 6 months after the publication of the primary results and for a period of 5 years.
Researchers with a methodologically sound proposal, approved by an independent review committee. Data requestors will be required to sign a data access agreement.
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| ID | Term |
|---|---|
| D000094666 | Aortic Intramural Hematoma |
| ID | Term |
|---|---|
| D000094683 | Acute Aortic Syndrome |
| D001018 | Aortic Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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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.
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Participant Blinding: The patient will not be informed of whether they received a Ascending Aorta/Hemiarch or Total Arch Replacement procedure. This is maintained through consistent post-operative communication that does not disclose the specific surgical technique.
Outcome Assessor Blinding: Members of the independent clinical event adjudication/imaging review team who assess reintervention-related outcomes are blinded to treatment allocation.
Care Provider (Surgeon) Blinding: The operating surgeons cannot be blinded due to the nature of the surgical interventions.
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| Ascending Aorta Replacement With Total Arch Replacement and Frozen Elephant Trunk | Procedure | 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. |
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| 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. | 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. | 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. | Through hospital discharge |
| D006406 |
| Hematoma |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |