Status:
RECRUITING
Clinical Trial of BAO-G Technique in Complex Aortic Aneurysm Endovascular Repair (BAO-G-02)
Lead Sponsor:
Peking Union Medical College Hospital
Collaborating Sponsors:
Fudan University
First Affiliated Hospital, Sun Yat-Sen University
Conditions:
Thoracoabdominal Aortic Aneurysm
Endovascular Repair
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
Brief Summary
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 rec...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- Active bleeding or coagulopathy within 6 months (high bleeding risk)
- Uncontrolled hypertension (resting SBP \>180 mmHg or DBP \>110 mmHg)
- Uncontrolled diabetes (fasting blood glucose \>16.7 mmol/L)
- Severe hepatic/renal dysfunction (serum creatinine \>3 mg/dL, ALT/AST \>3×ULN)
- Concurrent participation in other interventional clinical trials
- Pregnancy or perinatal status
- Refusal to sign informed consent
Key Trial Info
Start Date :
January 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2035
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT07141251
Start Date
January 1 2022
End Date
December 31 2035
Last Update
September 5 2025
Active Locations (11)
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1
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100029
2
Fuwai Hospital, CAMS&PUMC
Beijing, Beijing Municipality, China, 100037
3
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730
4
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China, 400016