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

Comparison of Femorofemoral Bypass and Left-Heart Bypass Techniques in Open Thoracoabdominal Aortic Aneurysm Repair: A Study Protocol for Multicenter, Two-Arm, Open-Label, Randomized, ParalleI-Controlled Non-Inferiority Trial

This will test whether femorofemoral bypass or left‑heart bypass works better for adults having open repair of a thoracoabdominal aortic aneurysm.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 236 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Beijing Anzhen Hospital (Academic / other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT07518251 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults (≥18 years) with CTA‑confirmed thoracoabdominal aortic aneurysm who require cardiopulmonary bypass for open repair and can give informed consent are the intended participants.

Not a fit: Patients with chronic renal failure, chronic heart failure, significant coronary disease requiring surgery, hepatic insufficiency, inflammatory or infectious aortic disease, recent malignancy, or pregnancy are excluded and unlikely to benefit from this trial.

Why it matters

Potential benefit: If one bypass method proves superior, it could reduce major complications and early mortality after open thoracoabdominal aortic aneurysm repair.

How similar studies have performed: Observational and single‑center reports have described outcomes with both left‑heart and peripheral/femorofemoral bypass approaches, but high‑quality randomized comparisons are limited, so this trial addresses a clinical evidence gap.

Eligibility criteria

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 this trial is running

Beijing, Beijing Municipality

• Beijing Anzhen Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Su-Wei Chen, Doctor

Conditions Thoracoabdominal Aortic Aneurysm; Cardiopulmonary Bypass; Open Repair