AAR/AAR+HAR vs AAR+TAR+FET for Type A Aortic Intramural Hematoma

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Aortic Intramural Hematoma
• Intervention / Treatment: Procedure: Ascending Aorta Replacement / Ascending Aorta Plus Hemiarch Replacement; Procedure: Ascending Aorta Replacement With Total Arch Replacement and Frozen Elephant Trunk

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 Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: kexiang liu, MD，Ph.D.; Phone Number: 17390920328; Email: kxliu64@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AAR/AAR+HAR Group; 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.	Procedure: Ascending Aorta Replacement / Ascending Aorta Plus Hemiarch Replacement; 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.; Other Names: AAR/AAR+HAR
Active Comparator: AAR+TAR+FET Group; 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.	Procedure: Ascending Aorta Replacement With Total Arch Replacement and Frozen Elephant Trunk; 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.; Other Names: AAR+TAR+FET

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Second Hospital of Jilin University
• Investigators: Principal Investigator: kexiang Liu, Ph.D., Department of Cardiovascular Surgery, The Second Hospital of Jilin University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): October 30, 2027

Study Registration Dates

• First Submitted: November 26, 2025
• First Submitted That Met QC Criteria: November 26, 2025
• First Posted (Actual): December 9, 2025

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Non-Inferiority Trial; Aortic Intramural Hematoma, Type A; Hemiarch Replacement; Total Arch Replacement
• Additional Relevant MeSH Terms: Acute Aortic Syndrome; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Hemorrhage; Aortic Diseases; Pathological Conditions, Signs and Symptoms; Hematoma; Aortic Intramural Hematoma
• Other Study ID Numbers: JDEYXWK305

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Beginning 6 months after the publication of the primary results and for a period of 5 years.
• IPD Sharing Access Criteria: Researchers with a methodologically sound proposal, approved by an independent review committee. Data requestors will be required to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No