Femorofemoral versus left‑heart bypass for open thoracoabdominal aortic aneurysm repair

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, open‑label, randomized trial will enroll 236 adults with thoracoabdominal aortic aneurysm at four hospitals in China and randomize them 1:1 to receive either femorofemoral cardiopulmonary bypass (fCPB) or left‑heart bypass (LHB) during open thoracoabdominal aortic aneurysm repair. Participants are followed for one year to compare major adverse events including surgical mortality, need for renal replacement therapy, stroke, and spinal cord ischemia, and to compare intraoperative blood transfusion volume, duration of mechanical ventilation, and early mortality. Eligible patients are adults with CTA‑confirmed thoracoabdominal aortic aneurysm who require cardiopulmonary bypass and can consent and complete follow‑up, while those with significant comorbidities (for example chronic renal failure, advanced heart or liver disease), inflammatory or infectious aortic disease, prior malignancy, or pregnancy are excluded. The trial uses parallel‑group allocation and standard perioperative care at high‑volume cardiac surgery centers.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Computed tomography angiography (CTA) confirmed as ATAAD according to the 2022 ACC/AHA Guideline for the Diagnosis and Management of Aortic Disease;
2. Adult patients (≥18 years old);
3. Indications for TAAAR are available and requiring cardiopulmonary bypass;
4. Signed informed consent and availability for follow-up.

Exclusion Criteria:

1. History of chronic renal failure, chronic heart failure, Coronary heart disease with established surgical indications, hepatocirrhosis, and hepatic insufficiency;
2. History of severe cerebral infarction (with cerebral infarction sequels);
3. Inflammatory aortic diseases, such as Takayasu arteritis and Behçet's disease, etc;
4. History of infectious aortic diseases;
5. History of malignancy or previous radiotherapy;
6. Pregnant or feeding women, or anyone planning to reproduce during the test period;
7. Participating in any other clinical trial;
8. Having other causes not eligible for operation.

Where it's running

• Beijing Anzhen Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Su-Wei Chen, Doctor
• Email: 15524612655@163.com
• Phone: +86 155 2461 2655

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.