Evaluation of the BAO-G Technique for Endovascular Repair of Complex Thoracoabdominal Aortic Aneurysms A Multicenter Phase 1 Study of Multi-Branch Aortic Reconstruction Using G-iliac System

What this Trial Is About

Researchers are evaluating a new technique called Multi-Branch AOrtic Reconstruction with G-iliac System BAO-G for treating complex aortic aneurysms. This prospective, multicenter, open-label, single-arm clinical trial aims to assess the safety around the time of surgery and the effectiveness over five years of the BAO-G technique in repairing complex aortic aneurysms. The study seeks to provide evidence to guide future treatment choices for patients with this condition. Participants will receive the BAO-G procedure, which uses off-the-shelf iliac branched devices to reconstruct the visceral branches during endovascular repair of thoracoabdominal aortic aneurysms. The study includes one group undergoing this experimental procedure. The primary outcomes measured are the rates of technical success within 30 days after surgery and clinical success within five years postoperatively. During the study, participants will be closely monitored for various outcomes including aneurysm-related death, aneurysm rupture, neurological complications, kidney failure, bowel ischemia, stroke, blood loss during surgery, vascular access issues, operative time, hospital stay length, stent-related complications, and need for reoperation. These assessments will take place during the operation and at regular intervals up to five years after surgery to evaluate both short-term safety and long-term effectiveness.

Clinical Trial of BAO-G Technique in Complex Aortic Aneurysm Endovascular Repair (BAO-G-02)