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

Official title

A Prospective, Randomized, Non-Inferiority Trial of AAR/AAR+HAR Versus AAR+TAR+FET in Type A Aortic Intramural Hematoma

Overview

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

• 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.

Primary outcome measures

• Rate of reintervention on the aortic arch or descending aorta [Time frame: 6 to 12 months after surgery]

Secondary outcome measures (5)

• Aortic Cross-Clamp Time [Time frame: Intraoperative]
• Circulatory Arrest Time [Time frame: Intraoperative]
• Major Adverse Cardiovascular Events (MACE) [Time frame: Through 30 days after surgery]
• Other perioperative complications [Time frame: Through 30 days after surgery]
• Total hospitalization cost [Time frame: Through hospital discharge]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07272655 · JDEYXWK305

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗