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

Capital Medical University

Status: Enrolling

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

Treatments: Procedure: Total Arch Replacement combined Frozen Elephant Trunk Implantation using Bilateral Antegrade Cerebral Perfusion under Moderate Hypothermic Circulatory Arrest; Procedure: Arch-Clamping Technique under Moderate Hypothermia; Procedure: Arch-Clamping Technique under Mild Hypothermia

Study type: Interventional

Funder types: Other

Identifiers

NCT07150559

2023ZD0504402

Details and patient eligibility

About

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.

Enrollment: 306 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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306 participants in 3 patient groups

Arch-clamping under mild hypothermia

Experimental group

Description:

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

Treatment:

Procedure: Arch-Clamping Technique under Mild Hypothermia

Arch-clamping under moderate hypothermia

Experimental group

Description:

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

Treatment:

Procedure: Arch-Clamping Technique under Moderate Hypothermia

Sun's procedure using bACP

Active Comparator group

Description:

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

Treatment:

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