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

RecruitingNAAges 18 Years - 80 YearsAllPeking Union Medical College Hospital
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: 1. Diagnosed with Crawford type Ⅰ- Ⅴ 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 2. Patients with pseudoaneurysms, post-dissection aneurysmal degeneration, or failure of previous EVAR were also eligible if the pathology involved the visceral aortic segment; 3. Scheduled for endovascular aortic repair with commercially available iliac branch devices for visceral artery reconstruction 4. Signed informed consent and committed to protocol-defined follow-up Exclusion Criteria: 1. Acquired language barrier, intellectual decline, cognitive impairment, or mental illness preventing informed consent 2. Uncontrolled autoimmune diseases (e.g., Takayasu arteritis, systemic lupus erythematosus, vasculitis) 3. End-stage renal/hepatic/cardiac/pulmonary failure or malignancy diagnosed within 5 years, likely to cause mortality during follow-up 4. Active bleeding or coagulopathy within 6 months (high bleeding risk) 5. Uncontrolled hypertension (resting SBP \>180 mmHg or DBP \>110 mmHg) 6. Uncontrolled diabetes (fasting blood glucose \>16.7 mmol/L) 7. Severe hepatic/renal dysfunction (serum creatinine \>3 mg/dL, ALT/AST \>3×ULN) 8. Concurrent participation in other interventional clinical trials 9. Pregnancy or perinatal status 10. Refusal to sign informed consent
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What it tests

  • BAO-G
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Where

11 sites
Beijing Anzhen Hospital, Capital Medical University
Beijing, China
Fuwai Hospital, CAMS&PUMC
Beijing, China
Peking Union Medical College Hospital
Beijing, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, China
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, China
Hainan General Hospital
Haikou, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, China
The Affiliated Hospital of Jining Medical University
Jining, China

…and 3 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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