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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
BAO-G
Procedure/SurgeryUsing G-iliac system to reconstruct the visceral branches of in endovascular repair of thoracoabdominal aortic aneurysm.
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: BAO-G groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of primary technical success
The preoperative planned protocol was successfully completed, including aneurysm repair and visceral branch reconstruction, with no aneurysm-related conversion to open surgery/death, no type I/III endoleak, and no branch occlusion within 30 days postoperatively.
Time frame
within 30 days postoperatively2
Incidence of clinical success
The preoperative planned protocol was successfully completed, including aneurysm repair and visceral branch reconstruction, without significant disabling permanent clinical sequelae, and with the patient remained free from aneurysm-related mortality or secondary interventions due to aneurysm progression during follow-up.
Time frame
within 5 years postoperativelySecondary outcomes
1
Incidence of aneurysm-related death occurred during perioperative period
All deaths occurring before discharge or within 30 days postoperatively that were attributable to the surgical treatment (including stent-induced retrograde dissection, procedure-related aneurysm rupture, branch occlusion causing severe visceral ischemia, etc.) or aneurysm progression, unless there is clear evidence demonstrating the patient's death was unrelated to the aneurysm.
Time frame
within 30 days postoperatively2
Incidence of rupture of aneurysms
Time frame
within 5 years postoperatively3
Incidence of permanent paraplegia
Time frame
within 5 years postoperatively4
Incidence of permanent lower limb monoparesis
Time frame
within 5 years postoperativelySponsors and contacts
Click on the lead sponsor to view all of their trials.
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
Source ClinicalTrials.gov