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
Study Overview
Status
Conditions
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
Enrollment (Estimated)
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
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
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.
|
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:
|
|
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.
|
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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
6 to 12 months after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Aortic Cross-Clamp Time
Time Frame: Intraoperative
|
Duration (minutes) of aortic cross-clamping during surgery.
|
Intraoperative
|
|
Circulatory Arrest Time
Time Frame: Intraoperative
|
Duration (minutes) of total circulatory arrest.
|
Intraoperative
|
|
Major Adverse Cardiovascular Events (MACE)
Time Frame: Through 30 days after surgery
|
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
Time Frame: Through 30 days after surgery
|
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
Time Frame: Through hospital discharge
|
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
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)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- JDEY-TAIMH
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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