About this trial
Multi-Branch AOrtic Reconstruction With G-iliac System (BAO-G) Technique is a novel technique of endovascular repair of complex aortic aneurysm, which using off-the-shelf iliac branched devices to reconstruct the visceral branches. This study aims to verify the perioperative safety and 5-year efficacy of BAO-G technique in the endovascular treatment of complex aortic aneurysms through a prospective, multicenter, open-label, single-arm clinical trial, and to provide evidence for the selection of clinical procedures for complex aortic aneurysm patients in the future.
Eligibility criteria
Qualifiers
Diagnosed with Crawford type III-IV thoracoabdominal aortic aneurysm or complex abdominal aortic aneurysm, with a healthy proximal landing zone (>20mm length, angulation <60°) in the descending aorta and maximum aneurysm diameter ≥4cm
Scheduled for endovascular aortic repair with commercially available iliac branch devices for visceral artery reconstruction
Signed informed consent and committed to protocol-defined follow-up
Disqualifiers
Acquired language barrier, intellectual decline, cognitive impairment, or mental illness preventing informed consent
Uncontrolled autoimmune diseases (e.g., Takayasu arteritis, systemic lupus erythematosus, vasculitis)
Prior aortic surgery with stent-graft or prosthetic vascular graft implantation
End-stage renal/hepatic/cardiac/pulmonary failure or malignancy diagnosed within 5 years, likely to cause mortality during follow-up
Trial design
Treatments tested in this trial
- BAO-G
Treatment groups
Sponsors and collaborators
Peking Union Medical College Hospital
Lead sponsor
Fudan University
Collaborator
First Affiliated Hospital, Sun Yat-Sen University
Collaborator
Changhai Hospital
Collaborator
Chinese Academy of Medical Sciences, Fuwai Hospital
Collaborator
Beijing Anzhen Hospital
Collaborator
RenJi Hospital
Collaborator
Hainan General Hospital
Collaborator
The First Affiliated Hospital of Zhengzhou University
Collaborator
First Affiliated Hospital of Chongqing Medical University
Collaborator
Affiliated Hospital of Jining Medical University
Collaborator