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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorPeking Union Medical College Hospital

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

60 Participants
are divided into 1 treatment group

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