Study Comparing Two Bypass Techniques in Open Surgery for Thoracoabdominal Aortic Aneurysm Repair

What this Trial Is About

Researchers are conducting a multicenter, two-arm, open-label, randomized trial to compare two types of cardiopulmonary bypass techniques used in open thoracoabdominal aortic aneurysm repair TAAAR. The study aims to evaluate the safety and effectiveness of femorofemoral cardiopulmonary bypass fCPB versus left heart bypass LHB by examining major adverse events such as surgical mortality, renal replacement therapy, stroke, spinal cord injury, as well as blood transfusion volumes and mechanical ventilation durations. Participants diagnosed with thoracoabdominal aortic aneurysm will undergo the TAAAR procedure and be randomly assigned to receive either the fCPB or LHB technique. Both procedures involve clamping specific parts of the aorta and reconstructing arteries using a four-branched graft with an established surgical method. The study compares these techniques over a 1-year follow-up period after surgery. During the study, participants will be monitored for major adverse events at 30 days and 12 months post-operation. Secondary assessments include measuring blood product transfusion volumes during surgery and up to 3 days afterward, duration of mechanical ventilation up to 30 days post-surgery, and early mortality between 6 to 12 months. The trial plans to enroll 236 participants and assesses outcomes to evaluate the validity and safety of these bypass methods for TAAAR.

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