NCT07150559 Arch-Clamping Technique Under Mild Hypothermia in Treating With Acute Type A Aortic Dissection
| NCT ID | NCT07150559 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Beijing Anzhen Hospital |
| Condition | Acute Type A Aortic Dissection |
| Study Type | INTERVENTIONAL |
| Enrollment | 306 participants |
| Start Date | 2026-02-03 |
| Primary Completion | 2027-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 306 participants in total. It began in 2026-02-03 with a primary completion date of 2027-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: 1. Aortic CTA confirmed as ATAAD according to the 2022 ACC/AHA Guideline for the Diagnosis and Management of Aortic Disease; 2. Adult patients (18-70 years) weighing 50-120 kg; 3. Time interval between the onset of symptoms and operation is less than 14 days; 4. Indications for total aortic arch replacement are available; 5. Signed informed consent and availability for follow-up. Exclusion Criteria: 1. History of chronic renal failure, hepatocirrhosis, and hepatic insufficiency; 2. Severe gastrointestinal complications of non-aortic dissection, such as mesenteric ischemia, gastrointestinal bleeding, hepatopancreaticobiliary dysfunction, and intestinal obstruction; 3. History of severe cerebral infarction (with cerebral infarction sequels); 4. Preoperative intubation or unconsciousness; 5. Inflammatory aortic diseases, such as Takayasu arteritis and Behçet's disease, etc; 6. History of infectious aortic diseases; 7. History of cardiac and aortic surgery; 8. History of malignancy or previous radiotherapy; 9. Pregnant or feeding women, or anyone planning to reproduce during the test period; 10. Without an informed consent signature; 11. Participating in any other clinical trial; 12. Having other causes not eligible for operation.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07150559 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Acute Type A Aortic Dissection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07150559 currently recruiting?
Yes, NCT07150559 is actively recruiting participants. Contact the research team at 15524612655@163.com for enrollment information.
Where is the NCT07150559 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07150559 clinical trial?
NCT07150559 is sponsored by Beijing Anzhen Hospital. The trial plans to enroll 306 participants.