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

NARecruitingINTERVENTIONAL
Enrollment

306

Participants

Timeline

Start Date

September 5, 2025

Primary Completion Date

September 30, 2027

Study Completion Date

November 30, 2027

Conditions
Acute Type A Aortic DissectionHypothermiaTotal Aortic Arch ReplacementFrozen Elephant TrunkBilateral Antegrade Cerebral Perfusion
Interventions
PROCEDURE

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.

PROCEDURE

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.

PROCEDURE

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.

Trial Locations (1)

100013

RECRUITING

Beijing Anzhen Hospital, Beijing

All Listed Sponsors
collaborator

Yan'an Affiliated Hospital of Kunming Medical University

OTHER

collaborator

Xiangya Hospital of Central South University

OTHER

collaborator

West China Hospital

OTHER

collaborator

Guangzhou First People's Hospital

OTHER

collaborator

First Affiliated Hospital Xi'an Jiaotong University

OTHER

collaborator

Xijing Hospital,FMMU

UNKNOWN

lead

Beijing Anzhen Hospital

OTHER

NCT07150559 - Arch-Clamping Technique Under Mild Hypothermia in Treating With Acute Type A Aortic Dissection | Biotech Hunter | Biotech Hunter