The study is a multicenter, three-arm, open-label, randomized, parallel-controlled trial, which plans to enroll 306 participants diagnosed with acute type A aortic dissection (ATAAD) from 7 hospitals in China. All patients receive total arch replacement (TAR) combined with frozen elephant trunk (FET) implantation and are randomized to Group 1 (arch-clamping technique under mild hypothermia), Group 2 (arch-clamping technique under moderate hypothermia) and Group 3 (Sun's procedure using bilateral antegrade cerebral perfusion) in the ratio of 1:1:1. After a 1-year follow-up, the validity and safety of the mild hypothermic arch-clamping technique for ATAAD was evaluated via the incidence of major adverse events including death, renal replacement therapy, stroke, and paraplegia, as well as times of circulatory arrest, cardiopulmonary bypass, and mechanical ventilation, and length of ICU stay.
Aortic CTA confirmed as ATAAD according to the 2022 ACC/AHA Guideline for the Diagnosis and Management of Aortic Disease;
Adult patients (18-70 years) weighing 50-120 kg;
Time interval between the onset of symptoms and operation is less than 14 days;
Indications for total aortic arch replacement are available;
History of chronic renal failure, hepatocirrhosis, and hepatic insufficiency;
Severe gastrointestinal complications of non-aortic dissection, such as mesenteric ischemia, gastrointestinal bleeding, hepatopancreaticobiliary dysfunction, and intestinal obstruction;
History of severe cerebral infarction (with cerebral infarction sequels);
Preoperative intubation or unconsciousness;
Beijing Anzhen Hospital
Lead sponsor
Yan'an Affiliated Hospital of Kunming Medical University
Collaborator
Xiangya Hospital of Central South University
Collaborator
West China Hospital
Collaborator
Guangzhou First People's Hospital
Collaborator
First Affiliated Hospital Xi'an Jiaotong University
Collaborator
Xijing Hospital，FMMU
Collaborator