Actively Recruiting
Arch-Clamping Technique Under Mild Hypothermia in Treating With Acute Type A Aortic Dissection
Led by Beijing Anzhen Hospital · Updated on 2026-04-06
306
Participants Needed
1
Research Sites
107 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
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
Official 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 as acute type A aortic dissection according to the 2022 ACC/AHA Guideline
- Adult patients aged 18 to 70 years weighing 50 to 120 kg
- Time between symptom onset and operation less than 14 days
- Indications present for total aortic arch replacement
- Signed informed consent and availability for follow-up
You will not qualify if you...
- History of chronic renal failure, hepatocirrhosis, or hepatic insufficiency
- Severe gastrointestinal complications unrelated to aortic dissection, such as mesenteric ischemia or gastrointestinal bleeding
- History of severe cerebral infarction with lasting effects
- Preoperative intubation or unconsciousness
- Inflammatory aortic diseases like Takayasu arteritis or Behet's disease
- History of infectious aortic diseases
- Previous cardiac or aortic surgery
- History of cancer or prior radiotherapy
- Pregnant, breastfeeding, or planning pregnancy during the study
- No signed informed consent
- Participation in another clinical trial
- Other causes making operation unsuitable
AI-Screening
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Trial Site Locations
Total: 1 location
1
Beijing Anzhen Hospital
Beijing, Beijing Municipality, China, 100013
Actively Recruiting
Research Team
S
Su-Wei Chen, Doctor
CONTACT
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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