An interventional study of Arch-Clamping Technique under Mild Hypothermia and Arch-Clamping Technique under Moderate Hypothermia in Acute Type A Aortic Dissection, Hypothermia and Total Aortic Arch Replacement, sponsored by Beijing Anzhen Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-04-06.
Sponsored by Beijing Anzhen Hospital · Not applicable, Interventional, and Treatment
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.
449 studies on the registry are indexed under Hypothermia; 54 are open to participants now.
This study's planned enrollment of 306 is above the median of 77 across 328 interventional studies indexed under Hypothermia.
Browse Hypothermia studies →Beijing Anzhen Hospital is the lead sponsor of 192 studies on the registry; 102 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TAR + FET procedure is performed using arch-clamping technique under mild hypothermia.
Procedure: Arch-Clamping Technique under Mild Hypothermia
TAR + FET procedure is performed using arch-clamping technique under moderate hypothermia.
Procedure: Arch-Clamping Technique under Moderate Hypothermia
Total arch replacement and frozen elephant trunk implantation with moderate hypothermic circulatory arrest.
Procedure: Total Arch Replacement combined Frozen Elephant Trunk Implantation using Bilateral Antegrade Cerebral Perfusion under Moderate Hypothermic Circulatory Arrest
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.
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.
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.
Major adverse events
Major adverse events include death, renal replacement therapy, stroke, and paraplegia
Time frame: Thirty days and 12 months after the operation
Circulatory arrest time
Time interval between ceasing and restarting cardiopulmonary bypass when core temperature reaches moderate hypothermia.
Time frame: During surgery
Cardiopulmonary bypass time
Start-to-end time of cardiopulmonary bypass to complete aortic repair.
Time frame: During surgery
Mechanical ventilation time
Time interval between mechanical ventilation and extubation after operation
Time frame: Discharge / 30 days after operation
The length of ICU stay
Time interval from ICU admission to transfer or death
Time frame: Discharge / 30 days after operation
Plan to share: No
No publications or documents are linked to this record.
Started Feb 2026 (actual). Primary completion is estimated for Dec 2027, 22 months after the start.
Of 132 non-industry interventional studies with no phase under Hypothermia, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 36. This study's planned 22 months is above that.
Counting every sponsor, half of 135 studies reached it within 16 months; a quarter within 6 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
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