Actively Recruiting
Comparison of Femorofemoral Bypass and Left-Heart Bypass Techniques in Open Thoracoabdominal Aortic Aneurysm Repair: A Multicenter, Randomized, Open-Label Trial
Led by Beijing Anzhen Hospital · Updated on 2026-04-08
236
Participants Needed
1
Research Sites
19 weeks
Total Duration
On this page
Sponsors
B
Beijing Anzhen Hospital
Lead Sponsor
X
Xiangya Hospital of Central South University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are comparing two types of cardiopulmonary bypass techniques in patients diagnosed with thoracoabdominal aortic aneurysm disease (TAAA) who require open repair surgery. This multicenter, randomized, open-label trial in China will enroll 236 adult participants to evaluate the safety and effectiveness of femorofemoral cardiopulmonary bypass (fCPB) versus left-heart bypass (LHB) during thoracoabdominal aortic aneurysm repair (TAAAR). The study aims to determine which technique better reduces major adverse events such as surgical mortality, stroke, renal replacement therapy, and spinal cord injury, as well as other outcomes related to blood transfusion and ventilation support. Participants will undergo TAAAR surgery using one of two procedures: the experimental group will receive surgery under fCPB, involving femoral artery and vein access and specific aortic clamping techniques; the control group will undergo surgery under LHB using left inferior pulmonary vein and femoral artery access with similar occlusion and vessel reconstruction methods. Both groups will have the branches of a four-branched graft connected in a specific sequence to restore blood flow. The trial includes a one-year follow-up period to assess safety and efficacy measures. During the study, participants will be monitored for major adverse events at 30 days and 12 months post-operation, including surgical mortality, stroke, and other serious complications. Secondary outcomes include measuring blood product transfusion volume during surgery and the first three postoperative days, duration of mechanical ventilation, and early mortality up to 12 months after surgery. Follow-up visits will evaluate these outcomes to ensure comprehensive safety assessments. The total participation time spans from surgery through a one-year post-operative follow-up.
CONDITIONS
Brief Title
CompaRison of FEmorofemoral Bypass and Left-Heart ByPass Techniques in Open Thoracoabdominal AortIc Aneurysm Repair
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Computed tomography angiography (CTA) confirmed thoracoabdominal aortic aneurysm disease
- Adult patients 18 years old or older
- Indicated for thoracoabdominal aortic aneurysm repair requiring cardiopulmonary bypass
- Signed informed consent and available for follow-up
You will not qualify if you...
- History of chronic renal failure, chronic heart failure, coronary heart disease with surgical indications, liver cirrhosis, or liver insufficiency
- History of severe cerebral infarction with lasting effects
- Inflammatory aortic diseases such as Takayasu arteritis or Behçet's disease
- History of infectious aortic diseases
- History of malignancy or previous radiotherapy
- Pregnant, breastfeeding, or planning pregnancy during the trial period
- Participation in other clinical trials
- Other causes making the patient ineligible for surgery
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.
1 visit (in-person)
Duration - Surgical day
Participants undergo thoracoabdominal aortic aneurysm repair performed under either femorofemoral cardiopulmonary bypass or left heart bypass techniques.
1 surgical visit (in-person)
Duration - Postoperative 1 to 3 days
Participants receive immediate post-operative care including monitoring and management of recovery following the surgery.
Daily visits for up to 3 days (in-person)
Duration - Up to 12 months after surgery
Participants have follow-up visits to assess recovery, adverse events, and longer-term outcomes after surgery.
Visits at 30 days and periodically up to 12 months (in-person)
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
2
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