Aortic Intramural Hematoma
Conditions
Keywords
Aortic Intramural Hematoma, Type A, Hemiarch Replacement, Total Arch Replacement, Non-Inferiority Trial
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, major adverse cardiovascular events, other perioperative complications, and total hospitalization cost. A total of 400 participants will be enrolled.
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.
Interventions
PROCEDUREAscending 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.
PROCEDUREAscending 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
Second Hospital of Jilin University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of reintervention on the aortic arch or descending aorta | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Aortic Cross-Clamp Time | Intraoperative | Duration (minutes) of aortic cross-clamping during surgery. |
| Circulatory Arrest Time | Intraoperative | Duration (minutes) of total circulatory arrest. |
| Major Adverse Cardiovascular Events (MACE) | 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. |
| Other perioperative complications | 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. |
| Total hospitalization cost | 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. |
Contacts
CONTACTkexiang liu, MD，Ph.D.
PRINCIPAL_INVESTIGATORkexiang Liu, Ph.D.
Department of Cardiovascular Surgery, The Second Hospital of Jilin University
Outcome results
None listed