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

NCT07272655 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2026-05-08

No results posted yet for this study

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

Conditions

  • Aortic Intramural Hematoma

Interventions

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.

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.

Sponsors & Collaborators

  • Second Hospital of Jilin University

    lead OTHER

Principal Investigators

  • kexiang Liu, Ph.D. · Department of Cardiovascular Surgery, The Second Hospital of Jilin University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2027-06-30
Completion
2027-10-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07272655 on ClinicalTrials.gov