Acute Type A Aortic DissectionAHEADNCT07150559
Arch-Clamping Technique Under Mild Hypothermia in Treating With Acute Type A Aortic Dissection
A study testing Arch-Clamping Technique under Mild Hypothermia, Arch-Clamping Technique under Moderate Hypothermia and Total Arch Replacement combined Frozen Elephant Trunk Implantation using Bilateral Antegrade Cerebral Perfusion under Moderate Hypothermic Circulatory Arrest in people with Acute Type A Aortic Dissection and Hypothermia, run by Beijing Anzhen Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acute Type A Aortic Dissection, Hypothermia, Total Aortic Arch Replacement
- What is being tested?
- Arch-Clamping Technique under Mild Hypothermia, Arch-Clamping Technique under Moderate Hypothermia and Total Arch Replacement combined Frozen Elephant Trunk Implantation using Bilateral Antegrade Cerebral Perfusion under Moderate Hypothermic Circulatory Arrest
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 306 participants
- Where
- 1 siteChina
- Study dates
- 3 Feb 2026to 28 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Anzhen Hospital
Beijing, Beijing Municipality, 100013
Su-Wei Chen, Doctor, +86 155 2461 2655, 15524612655@163.com
About this study
Official 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
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
- Being tested
- Arch-Clamping Technique under Mild Hypothermia, Arch-Clamping Technique under Moderate Hypothermia, Total Arch Replacement combined Frozen Elephant Trunk Implantation using Bilateral Antegrade Cerebral Perfusion under Moderate Hypothermic Circulatory Arrest
- Medical subject headings
- Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arch-Clamping Technique under Mild HypothermiaProcedure or surgery
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 HypothermiaProcedure or surgery
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 ArrestProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Arch-clamping under mild hypothermia | Experimental | TAR + FET procedure is performed using arch-clamping technique under mild hypothermia. Receives: Procedure: Arch-Clamping Technique under Mild Hypothermia |
| Arch-clamping under moderate hypothermia | Experimental | TAR + FET procedure is performed using arch-clamping technique under moderate hypothermia. Receives: Procedure: 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. Receives: Procedure: Total Arch Replacement combined Frozen Elephant Trunk Implantation using Bilateral Antegrade Cerebral Perfusion under Moderate Hypothermic Circulatory Arrest |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse events
Major adverse events include death, renal replacement therapy, stroke, and paraplegia
Measured: Thirty days and 12 months after the operation
Secondary outcomes (4)
Circulatory arrest time
Time interval between ceasing and restarting cardiopulmonary bypass when core temperature reaches moderate hypothermia.
Measured: During surgery
Cardiopulmonary bypass time
Start-to-end time of cardiopulmonary bypass to complete aortic repair.
Measured: During surgery
Mechanical ventilation time
Time interval between mechanical ventilation and extubation after operation
Measured: Discharge / 30 days after operation
The length of ICU stay
Time interval from ICU admission to transfer or death
Measured: Discharge / 30 days after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2025
- Study start3 Feb 2026
- Primary completion30 Dec 2027 (estimated)
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Type A Aortic DissectionStudies of the same condition, open and under way.
- More trials run by Beijing Anzhen HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a multicenter, three-arm, open-label, randomized, parallel-controlled trial.
- Masking
- None (open label)
- Enrolment
- 306 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Yan'an Affiliated Hospital of Kunming Medical University, Xiangya Hospital of Central South University, West China Hospital, Guangzhou First People's Hospital, First Affiliated Hospital Xi'an Jiaotong University, Xijing Hospital，FMMU
- Responsible party
- Principal investigator, Junming Zhu, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07150559
- Sponsor's protocol ID
- 2023ZD0504402
- Acronym
- AHEAD
- Status last verified
- Sep 2025
- First submitted
- 25 Aug 2025
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07150559
- Acronym / sponsor ID
- AHEAD / 2023ZD0504402
- Conditions
- Acute Type A Aortic Dissection, Hypothermia, Total Aortic Arch Replacement, Frozen Elephant Trunk, Bilateral Antegrade Cerebral Perfusion
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 306 participants (estimated)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Collaborators
- Yan'an Affiliated Hospital of Kunming Medical University, Xiangya Hospital of Central South University, West China Hospital, Guangzhou First People's Hospital, First Affiliated Hospital Xi'an Jiaotong University, Xijing Hospital，FMMU
- Study start
- 3 Feb 2026 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 28 Feb 2028 (estimated)
- First posted
- 2 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This study is a multicenter, three-arm, open-label, randomized, parallel-controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Arch-clamping under mild hypothermia | Experimental | Procedure: Arch-Clamping Technique under Mild HypothermiaTAR + FET procedure is performed using arch-clamping technique under mild hypothermia. |
| Arch-clamping under moderate hypothermia | Experimental | Procedure: Arch-Clamping Technique under Moderate HypothermiaTAR + FET procedure is performed using arch-clamping technique under moderate hypothermia. |
| Sun's procedure using bACP | Active comparator | Procedure: Total Arch Replacement combined Frozen Elephant Trunk Implantation using Bilateral Antegrade Cerebral Perfusion under Moderate Hypothermic Circulatory ArrestTotal arch replacement and frozen elephant trunk implantation with moderate hypothermic circulatory arrest. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arch-Clamping Technique under Mild HypothermiaThis 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. | Procedure or surgery | Arch-clamping under mild hypothermia |
| Arch-Clamping Technique under Moderate HypothermiaThis 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. | Procedure or surgery | Arch-clamping under moderate hypothermia |
| Total Arch Replacement combined Frozen Elephant Trunk Implantation using Bilateral Antegrade Cerebral Perfusion under Moderate Hypothermic Circulatory ArrestThis 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. | Procedure or surgery | Sun's procedure using bACP |
Primary outcome
Major adverse events
Time frame: Thirty days and 12 months after the operation
Major adverse events include death, renal replacement therapy, stroke, and paraplegia
4 secondary outcomes
Circulatory arrest time
Time frame: During surgery
Cardiopulmonary bypass time
Time frame: During surgery
Mechanical ventilation time
Time frame: Discharge / 30 days after operation
The length of ICU stay
Time frame: Discharge / 30 days after operation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arch-Clamping Technique under Mild Hypothermia, Arch-Clamping Technique under Moderate Hypothermia and Total Arch Replacement combined Frozen Elephant Trunk Implantation using Bilateral Antegrade Cerebral Perfusion under Moderate Hypothermic Circulatory Arrest in people with Acute Type A Aortic Dissection and Hypothermia, run by Beijing Anzhen Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Su-Wei Chen, Doctor (+86 155 2461 2655, 15524612655@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse events (time frame: Thirty days and 12 months after the operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.