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NCT Number: NCT07150559

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

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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Key information

Conditions

Acute Type A Aortic Dissection Bilateral Antegrade Cerebral Perfusion Body Temperature Changes Frozen Elephant Trunk Hypothermia Pathological Conditions, Signs and Symptoms Signs and Symptoms Total Aortic Arch Replacement

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Anzhen Hospital

Beijing, Beijing Municipality, 100013, China

Location status: Recruiting

Location contact

Su-Wei Chen, Doctor

CONTACT

[email protected]

+86 155 2461 2655

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aortic CTA confirmed as ATAAD according to the 2022 ACC/AHA Guideline for the Diagnosis and Management of Aortic Disease;
  • Adult patients (18-70 years) weighing 50-120 kg;
  • Time interval between the onset of symptoms and operation is less than 14 days;
  • Indications for total aortic arch replacement are available;
  • Signed informed consent and availability for follow-up.

Exclusion criteria

  • History of chronic renal failure, hepatocirrhosis, and hepatic insufficiency;
  • Severe gastrointestinal complications of non-aortic dissection, such as mesenteric ischemia, gastrointestinal bleeding, hepatopancreaticobiliary dysfunction, and intestinal obstruction;
  • History of severe cerebral infarction (with cerebral infarction sequels);
  • Preoperative intubation or unconsciousness;
  • Inflammatory aortic diseases, such as Takayasu arteritis and Behçet's disease, etc;
  • History of infectious aortic diseases;
  • History of cardiac and aortic surgery;
  • History of malignancy or previous radiotherapy;
  • Pregnant or feeding women, or anyone planning to reproduce during the test period;
  • Without an informed consent signature;
  • Participating in any other clinical trial;
  • Having other causes not eligible for operation.

Treatment and study plan

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.

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.

Primary outcomes

  1. Major adverse events

    Time frame: Thirty days and 12 months after the operation

    Major adverse events include death, renal replacement therapy, stroke, and paraplegia

Secondary outcomes

  1. Circulatory arrest time

    Time frame: During surgery

    Time interval between ceasing and restarting cardiopulmonary bypass when core temperature reaches moderate hypothermia.

  2. Cardiopulmonary bypass time

    Time frame: During surgery

    Start-to-end time of cardiopulmonary bypass to complete aortic repair.

  3. Mechanical ventilation time

    Time frame: Discharge / 30 days after operation

    Time interval between mechanical ventilation and extubation after operation

  4. The length of ICU stay

    Time frame: Discharge / 30 days after operation

    Time interval from ICU admission to transfer or death

Study contacts

Contact information is provided by the study sponsor or research team.

Su-Wei Chen, Doctor

CONTACT

[email protected]

+86 155 2461 2655

Sponsors and collaborators

Lead sponsor

Beijing Anzhen Hospital

Other

Collaborators

  • First Affiliated Hospital Xi'an Jiaotong University
  • Guangzhou First People's Hospital
  • West China Hospital
  • Xiangya Hospital of Central South University
  • Xijing Hospital，FMMU
  • Yan'an Affiliated Hospital of Kunming Medical University

Registry information

Official study title

Arch-Clamping Technique Under Mild Hypothermia in Treating With Acute Type A Aortic Dissection: Study Protocol for a Multicenter, Three-arm, Open-label, Randomized, Parallel-controlled Trial

Acronym: AHEAD

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Sep 2, 2025
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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