CompaRison of FEmorofemoral Bypass and Left-Heart ByPass Techniques in Open Thoracoabdominal AortIc Aneurysm Repair

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeijing Anzhen Hospital

About this trial

The study is a multicenter, two-arm, open-label, randomized, parallel-controlled trial, which plans to enroll 236 participants diagnosed with TAAA from 4 hospitals in China. All patients receive TAAAR procedure and are randomized to control group (LHB) and experimental group (fCPB) in the ratio of 1:1. After a 1-year follow-up, the validity and safety of the different cardiopulmonary bypass for TAAAR is evaluated via the incidence of major adverse events including surgical mortality, RRT, stroke, and SCI, as well as intraoperative blood product transfusion volume, mechanical ventilation, and early mortality.

Eligibility criteria

Qualifiers

Computed tomography angiography (CTA) confirmed as ATAAD according to the 2022 ACC/AHA Guideline for the Diagnosis and Management of Aortic Disease;

Adult patients (≥18 years old);

Indications for TAAAR are available and requiring cardiopulmonary bypass;

Signed informed consent and availability for follow-up.

Disqualifiers

History of chronic renal failure, chronic heart failure, Coronary heart disease with established surgical indications, hepatocirrhosis, and hepatic insufficiency;

History of severe cerebral infarction (with cerebral infarction sequels);

Inflammatory aortic diseases, such as Takayasu arteritis and Behçet's disease, etc;

History of infectious aortic diseases;

Trial design

Treatments tested in this trial

  • Thoracoabdominal aortic aneurysm repair under fCPB
  • Thoracoabdominal aortic aneurysm repair under LHB

Treatment groups

236 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Beijing Anzhen Hospital

Lead sponsor

Xiangya Hospital of Central South University

Collaborator

Guangdong Provincial People's Hospital

Collaborator

Guangzhou First People's Hospital

Collaborator