Clinical Trial of BAO-G Technique in Complex Aortic Aneurysm Endovascular Repair (BAO-G-02)
Recruiting now · Phase 1
Conditions studied: Thoracoabdominal Aortic Aneurysm, Endovascular Repair, Complex Aortic Aneurysms
In brief
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.
Key facts
- Study ID
- NCT07141251
- Run by
- Peking Union Medical College Hospital
- People needed
- 60
- Starts
- 2022-01-01
- Expected to finish
- 2035-12-31
- Last updated by the study team
- 2025-09-05
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Beijing Anzhen Hospital, Capital Medical University — Beijing, Beijing Municipality, China (enrolling)
- Fuwai Hospital, CAMS&PUMC — Beijing, Beijing Municipality, China (enrolling)
- Peking Union Medical College Hospital — Beijing, Beijing Municipality, China (enrolling)
- The First Affiliated Hospital of Chongqing Medical University — Chongqing, Chongqing Municipality, China (enrolling)
- The First Affiliated Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China (enrolling)
- Hainan General Hospital — Haikou, Hainan, China (enrolling)
- The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (enrolling)
- The Affiliated Hospital of Jining Medical University — Jining, Shandong, China (enrolling)
- Zhongshan Hospital, Fudan University — Shanghai, Shanghai Municipality, China (enrolling)
- Renji Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai Municipality, China (enrolling)
- Changhai Hospital — Shanghai, Shanghai Municipality, China (enrolling)
Full record on ClinicalTrials.gov
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