Clinical Trial of BAO-G Technique in Complex Aortic Aneurysm Endovascular Repair (BAO-G-02)
Multicenter, Open-labeled, Single-arm Clinical Trial of Multi-Branch AOrtic Reconstruction of Complex Aortic Aneurysm With G-iliac System [BAO-G] Technique
Peking Union Medical College Hospital
60 participants
Jan 1, 2022
INTERVENTIONAL
Conditions
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 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
Inclusion Criteria3
- 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 Criteria11
- 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
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Interventions
Using G-iliac system to reconstruct the visceral branches of in endovascular repair of thoracoabdominal aortic aneurysm.
Locations(11)
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NCT07141251