Hemiarch vs. Total Arch With FET for Type A Aortic IMH

Overview

This is a prospective, randomized, double-blind, non-inferiority clinical trial designed to compare the efficacy and safety of two surgical strategies for Type A aortic intramural hematoma (TAIMH): (1) Ascending aorta /hemiarch replacement (A/HAR), and (2) Ascending aorta with total arch replacement and frozen elephant trunk (TARFET). Patients with acute TAIMH will be enrolled based on computed tomography angiography (CTA) confirmation of a completely thrombosed false lumen in the ascending aorta and aortic arch. Eligible participants will be randomly assigned in a 1:1 ratio to either the A/HAR group (experimental) or the TARFET group (active comparator). The primary endpoint is the rate of perioperative false lumen patency in the aortic arch and descending aorta, assessed postoperatively by a blinded, independent imaging core laboratory using CTA. Secondary endpoints include the aortic cross-clamp time, circulatory arrest time, total operation time, aortic reintervention rate, and perioperative complications, rate of false lumen patency in the aortic arch and descending aorta at 6 - 12 months. The study tests the non-inferiority hypothesis that the less extensive A/HAR strategy is not inferior to the more extensive TARFET strategy in preventing early false lumen patency, while also exploring its potential superiority regarding other operative outcomes, such as reduced procedure times and lower incidence of complications. A total of 300 participants will be enrolled to ensure adequate statistical power. The findings from this trial are expected to provide high-quality evidence to guide optimal surgical strategies for patients with this unique aortic pathology.