Actively Recruiting
Arch-Clamping Technique Under Mild Hypothermia in Treating Acute Type A Aortic Dissection: Multicenter, Randomized, Parallel-Controlled Trial
Led by Beijing Anzhen Hospital · Updated on 2026-04-06
306
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
Sponsors
B
Beijing Anzhen Hospital
Lead Sponsor
Y
Yan'an Affiliated Hospital of Kunming Medical University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are conducting a multicenter, randomized clinical trial to evaluate different surgical techniques for treating Acute Type A Aortic Dissection (ATAAD). The study aims to compare the safety and effectiveness of arch-clamping techniques performed under mild and moderate hypothermia against Sun's procedure using bilateral antegrade cerebral perfusion. The trial involves 306 adult participants diagnosed with ATAAD from multiple hospitals in China to better understand major adverse events and recovery outcomes after surgery. Participants undergo total arch replacement combined with frozen elephant trunk implantation, then are randomly assigned to one of three groups: arch-clamping under mild hypothermia, arch-clamping under moderate hypothermia, or Sun's procedure under moderate hypothermic circulatory arrest with bilateral antegrade cerebral perfusion. Each surgical method involves specific steps to restore blood flow and reconstruct arteries using grafts during the operation. During the study, participants are closely monitored for one year after surgery. Researchers assess major adverse events such as death, need for renal replacement therapy, stroke, and paraplegia. They also measure surgical factors including circulatory arrest time, cardiopulmonary bypass time, mechanical ventilation duration, and length of ICU stay. Follow-up evaluations help determine the safety and validity of the mild hypothermic arch-clamping technique compared to the others.
CONDITIONS
Brief Title
Arch-Clamping Technique Under Mild Hypothermia in Treating With Acute Type A Aortic Dissection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aortic CTA confirmed diagnosis of Acute Type A Aortic Dissection according to 2022 guidelines
- Adults aged 18 to 70 years weighing 50 to 120 kg
- Time from symptom onset to operation less than 14 days
- Indications for total aortic arch replacement present
- Signed informed consent and ability to follow up
You will not qualify if you...
- History of chronic renal failure, liver cirrhosis, or hepatic insufficiency
- Severe non-aortic gastrointestinal complications such as mesenteric ischemia or bleeding
- History of severe cerebral infarction with lasting effects
- Preoperative intubation or unconsciousness
- Inflammatory aortic diseases like Takayasu arteritis or Behçet's disease
- History of infectious aortic diseases
- Previous cardiac or aortic surgery
- History of cancer or prior radiotherapy
- Pregnant or breastfeeding women, or planning pregnancy during the study
- No signed informed consent
- Participation in other clinical trials
- Other conditions making surgery unsuitable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - Hospital stay until discharge
Participants undergo one of the surgical procedures to treat acute type A aortic dissection, followed by immediate post-operative care including monitoring in the ICU.
Approximately 1 surgical visit and hospital stay including ICU care
Duration - Up to 12 months after the operation
Participants are monitored for major adverse events and recovery progress up to 12 months after surgery.
Follow-up visits at 30 days and multiple visits up to 12 months
Trial Site Locations
Total: 1 location
1
Beijing Anzhen Hospital
Beijing, Beijing Municipality, China, 100013
Actively Recruiting
Research Team
S
Su-Wei Chen, Doctor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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