Arch-Clamping Technique Under Mild Hypothermia in Treating With Acute Type A Aortic Dissection

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.

NCT Number	NCT07150559
Lead Sponsor	Beijing Anzhen Hospital Collaborators: Yan'an Affiliated Hospital of Kunming Medical University, Xiangya Hospital of Central South University, West China Hospital, Guangzhou First People's Hospital, First Affiliated Hospital Xi'an Jiaotong University, Xijing Hospital，FMMU
Conditions	Acute Type A Aortic Dissection, Hypothermia, Total Aortic Arch Replacement, Frozen Elephant Trunk, Bilateral Antegrade Cerebral Perfusion
Enrollment	306 participants
Start Date	2026-02-03
Primary Completion	2027-12-30 (estimated)
Study Completion	2028-02-28 (estimated)
Updated on ClinicalTrials.gov	2026-04-06