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

Sponsor: Peking Union Medical College Hospital • ClinicalTrials.gov ID: NCT07141251

Registry updated: 2026-10-15

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Description

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.

Interventions

BAO-G (Procedure)
Using G-iliac system to reconstruct the visceral branches of in endovascular repair of thoracoabdominal aortic aneurysm.

Eligibility criteria

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

Conditions

Thoracoabdominal Aortic Aneurysm Endovascular Repair Complex Aortic Aneurysms

Locations

Beijing Anzhen Hospital, Capital Medical University — Beijing, Beijing Municipality, China
Fuwai Hospital, CAMS&PUMC — Beijing, Beijing Municipality, China
Peking Union Medical College Hospital — Beijing, Beijing Municipality, China
The First Affiliated Hospital of Chongqing Medical University — Chongqing, Chongqing Municipality, China
The First Affiliated Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China
Hainan General Hospital — Haikou, Hainan, China
The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China
The Affiliated Hospital of Jining Medical University — Jining, Shandong, China
Zhongshan Hospital, Fudan University — Shanghai, Shanghai Municipality, China
Renji Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai Municipality, China
Changhai Hospital — Shanghai, Shanghai Municipality, China

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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