306
Participants
Start Date
September 5, 2025
Primary Completion Date
September 30, 2027
Study Completion Date
November 30, 2027
Arch-Clamping Technique under Mild Hypothermia
This procedure is performed under mild hypothermia. The branch arteries of the arch are reconstructed using the side arms of a Y-shaped graft, which allows bilateral antegrade cerebral perfusion (bACP) through the right axillary artery. A FET is deployed in the descending aorta and clamped together with the autologous aorta immediately, then distal perfusion is restored through the femoral artery. After the proximal procedures is completed, the distal anastomosis is performed in an end-to-end fashion. Finally, the main trunk of the Y-shaped graft is anastomosed to the proximal grafts.
Arch-Clamping Technique under Moderate Hypothermia
This procedure is performed under moderate hypothermia. The branch arteries of the arch are reconstructed using the side arms of a Y-shaped graft, which allow bACP through the right axillary artery. A FET is deployed in the descending aorta and clamped together with the autologous aorta immediately, then distal perfusion is restored through the femoral artery. After the proximal procedures is completed, the distal anastomosis is performed in an end-to-end fashion. Finally, the main trunk of the Y-shaped graft is anastomosed to the proximal grafts.
Total Arch Replacement combined Frozen Elephant Trunk Implantation using Bilateral Antegrade Cerebral Perfusion under Moderate Hypothermic Circulatory Arrest
This procedure is performed using bACP under MHCA, which involves FET deployment in the descending aorta followed by total arch replacement with a four-branched vascular graft. Deployment of the FET and suture of distal anastomosis are completed during bACP. MHCA is terminated and distal reperfusion is initiated once the distal anastomosis is completed, and the left carotid artery is reconstructed first (after which bACP is stopped, rewarming is started and the brain is perfused bilaterally). The root or valve procedures and some concomitant operations, if indicated, are performed during the cooling phase.
RECRUITING
Beijing Anzhen Hospital, Beijing
Yan'an Affiliated Hospital of Kunming Medical University
OTHER
Xiangya Hospital of Central South University
OTHER
West China Hospital
OTHER
Guangzhou First People's Hospital
OTHER
First Affiliated Hospital Xi'an Jiaotong University
OTHER
Xijing Hospital,FMMU
UNKNOWN
Beijing Anzhen Hospital
OTHER