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

NCT ID: NCT07150559

Last Updated: 2025-12-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 306 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-01
• Study Completion Date: 2028-02-28

Brief Summary

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.

Conditions

Acute Type A Aortic Dissection; Hypothermia; Total Aortic Arch Replacement; Frozen Elephant Trunk; Bilateral Antegrade Cerebral Perfusion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arch-clamping under mild hypothermia

TAR + FET procedure is performed using arch-clamping technique under mild hypothermia.

Group Type: EXPERIMENTAL

Arch-Clamping Technique under Mild Hypothermia

Intervention Type: 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.

Arch-clamping under moderate hypothermia

TAR + FET procedure is performed using arch-clamping technique under moderate hypothermia.

Group Type: EXPERIMENTAL

Arch-Clamping Technique under Moderate Hypothermia

Intervention Type: 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.

Sun's procedure using bACP

Total arch replacement and frozen elephant trunk implantation with moderate hypothermic circulatory arrest.

Group Type: ACTIVE_COMPARATOR

Total Arch Replacement combined Frozen Elephant Trunk Implantation using Bilateral Antegrade Cerebral Perfusion under Moderate Hypothermic Circulatory Arrest

Intervention Type: 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.

Interventions

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 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.

Intervention Type: 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 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.

Intervention Type: 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 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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Aortic CTA confirmed as ATAAD according to the 2022 ACC/AHA Guideline for the Diagnosis and Management of Aortic Disease;

2. Adult patients (18-70 years) weighing 50-120 kg;

3. Time interval between the onset of symptoms and operation is less than 14 days;

4. Indications for total aortic arch replacement are available;

5. Signed informed consent and availability for follow-up.

Exclusion Criteria

1. History of chronic renal failure, hepatocirrhosis, and hepatic insufficiency;

2. Severe gastrointestinal complications of non-aortic dissection, such as mesenteric ischemia, gastrointestinal bleeding, hepatopancreaticobiliary dysfunction, and intestinal obstruction;

3. History of severe cerebral infarction (with cerebral infarction sequels);

4. Preoperative intubation or unconsciousness;

5. Inflammatory aortic diseases, such as Takayasu arteritis and Behçet's disease, etc;

6. History of infectious aortic diseases;

7. History of cardiac and aortic surgery;

8. History of malignancy or previous radiotherapy;

9. Pregnant or feeding women, or anyone planning to reproduce during the test period;

10. Without an informed consent signature;

11. Participating in any other clinical trial;

12. Having other causes not eligible for operation.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yan'an Affiliated Hospital of Kunming Medical University

OTHER

Sponsor Role: collaborator

Xiangya Hospital of Central South University

OTHER

Sponsor Role: collaborator

West China Hospital

OTHER

Sponsor Role: collaborator

Guangzhou First People's Hospital

OTHER

Sponsor Role: collaborator

First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role: collaborator

Xijing Hospital，FMMU

UNKNOWN

Sponsor Role: collaborator

Beijing Anzhen Hospital

OTHER

Sponsor Role: lead

Responsible Party

Junming Zhu

Vice Chairman, Aortic Surgery Committee of Chinese Association of Cardiovascular Surgeons; President, Beijing Society for Thoracic and Cardiovascular Surgery; Director, Center for Aortic Surgery, Beijing Anzhen Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Beijing Anzhen Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Su-Wei Chen, Doctor

Role: CONTACT

15524612655@163.com

+86 155 2461 2655

Facility Contacts

Su-Wei Chen, Doctor

Role: primary

15524612655@163.com

+86 155 2461 2655

Other Identifiers

2023ZD0504402

Identifier Type: -

Identifier Source: org_study_id