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| Name | Class |
|---|---|
| Yan'an Affiliated Hospital of Kunming Medical University | OTHER |
| Xiangya Hospital of Central South University | OTHER |
| West China Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arch-clamping under mild hypothermia | Experimental | TAR + FET procedure is performed using arch-clamping technique under mild hypothermia. |
|
| Arch-clamping under moderate hypothermia | Experimental | TAR + FET procedure is performed using arch-clamping technique under moderate hypothermia. |
|
| Sun's procedure using bACP | Active Comparator | Total arch replacement and frozen elephant trunk implantation with moderate hypothermic circulatory arrest. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arch-Clamping Technique under Mild Hypothermia | Procedure | 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 are 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Major adverse events | Major adverse events include death, renal replacement therapy, stroke, and paraplegia | Thirty days and 12 months after the operation |
| Measure | Description | Time Frame |
|---|---|---|
| Circulatory arrest time | Time interval between ceasing and restarting cardiopulmonary bypass when core temperature reaches moderate hypothermia. | During surgery |
| Cardiopulmonary bypass time | Start-to-end time of cardiopulmonary bypass to complete aortic repair. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Su-Wei Chen, Doctor | Contact | +86 155 2461 2655 | 15524612655@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Anzhen Hospital | Recruiting | Beijing | Beijing Municipality | 100013 | China |
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| Guangzhou First People's Hospital |
| OTHER |
| First Affiliated Hospital Xi'an Jiaotong University | OTHER |
| Xijing Hospital，FMMU | UNKNOWN |
This study is a multicenter, three-arm, open-label, randomized, parallel-controlled trial.
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|
| Arch-Clamping Technique under Moderate Hypothermia | Procedure | 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 are 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 | Procedure | 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 the 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. |
|
| During surgery |
| Mechanical ventilation time | Time interval between mechanical ventilation and extubation after operation | Discharge / 30 days after operation |
| The length of ICU stay | Time interval from ICU admission to transfer or death | Discharge / 30 days after operation |
| ID | Term |
|---|---|
| D007035 | Hypothermia |
| ID | Term |
|---|---|
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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