Actively Recruiting
Clinical Trial of BAO-G Technique in Complex Aortic Aneurysm Endovascular Repair (BAO-G-02)
Led by Peking Union Medical College Hospital · Updated on 2025-09-05
60
Participants Needed
11
Research Sites
730 weeks
Total Duration
On this page
Sponsors
P
Peking Union Medical College Hospital
Lead Sponsor
F
Fudan University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Clinical Trial of BAO-G Technique in Complex Aortic Aneurysm Endovascular Repair (BAO-G-02)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
- Aged between 18 and 80 years
You will not qualify if you...
- Language barrier, intellectual decline, cognitive impairment, or mental illness preventing informed consent
- Uncontrolled autoimmune diseases such as Takayasu arteritis, systemic lupus erythematosus, or vasculitis
- Prior aortic surgery with stent-graft or prosthetic vascular graft implantation
- End-stage renal, hepatic, cardiac or pulmonary failure or malignancy diagnosed within 5 years likely to cause mortality during follow-up
- Active bleeding or coagulopathy within 6 months
- Uncontrolled hypertension (resting systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg)
- Uncontrolled diabetes (fasting blood glucose >16.7 mmol/L)
- Severe hepatic or renal dysfunction (serum creatinine >3 mg/dL, ALT/AST >3× upper limit of normal)
- Participation in other interventional clinical trials
- Pregnancy or perinatal status
- Refusal to sign informed consent
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 11 locations
1
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100029
Actively Recruiting
2
Fuwai Hospital, CAMS&PUMC
Beijing, Beijing Municipality, China, 100037
Actively Recruiting
3
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730
Actively Recruiting
4
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China, 400016
Actively Recruiting
5
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China, 510080
Actively Recruiting
6
Hainan General Hospital
Haikou, Hainan, China, 570311
Actively Recruiting
7
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450052
Actively Recruiting
8
The Affiliated Hospital of Jining Medical University
Jining, Shandong, China, 272000
Actively Recruiting
9
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
10
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 200127
Actively Recruiting
11
Changhai Hospital
Shanghai, Shanghai Municipality, China, 200433
Actively Recruiting
Research Team
B
Bao Liu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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