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

NCT07272655 | Not Yet Recruiting

• 1 other identifier: JDEYXWK305
• Study Type: interventional
• Target: 400
• Locations: 0 countries
• Sites: N/A

Brief 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, operation time, major adverse cardiovascular events, other perioperative complications, and total hospitalization cost. A total of 400 participants will be enrolled.

Conditions

Aortic Intramural Hematoma

Keywords

Aortic Intramural Hematoma, Type A; Hemiarch Replacement; Total Arch Replacement; Non-Inferiority Trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Aortic Cross-Clamp Time

  Intraoperative

• Circulatory Arrest Time

  Intraoperative

• Operation Time

  Intraoperative

• Major Adverse Cardiovascular Events (MACE)

  Through 30 days after surgery

• Other perioperative complications

  Through 30 days after surgery

Study Arms (2)

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.

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.

Procedure: Ascending Aorta Replacement With Total Arch Replacement and Frozen Elephant Trunk

Interventions

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.

Also known as: AAR/AAR+HAR

AAR/AAR+HAR Group

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.

Also known as: AAR+TAR+FET

AAR+TAR+FET Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Hospital of Jilin University: lead

MeSH Terms

Conditions

Aortic Intramural Hematoma

Condition Hierarchy (Ancestors)

Acute Aortic Syndrome; Aortic Diseases; Vascular Diseases; Cardiovascular Diseases; Hematoma; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• kexiang Liu, Ph.D.

  Department of Cardiovascular Surgery, The Second Hospital of Jilin University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

kexiang liu, MD，Ph.D.

CONTACT

17390920328; kxliu64@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Cardiovascular Surgery, Second Hospital of Jilin University

Model Details: 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.

Study Record Dates

• First Submitted: November 26, 2025
• First Posted: December 9, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): October 30, 2027
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Beginning 6 months after the publication of the primary results and for a period of 5 years.
• 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.