Actively Recruiting
Multicenter, Open-labeled, Single-arm Clinical Trial of Multi-Branch AOrtic Reconstruction of Complex Aortic Aneurysm With G-iliac System [BAO-G] Technique
Led by Peking Union Medical College Hospital · Updated on 2025-09-05
60
Participants Needed
11
Research Sites
260 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
Researchers are evaluating a new technique called Multi-Branch AOrtic Reconstruction with G-iliac System (BAO-G) for treating complex aortic aneurysms. This prospective, multicenter, open-label, single-arm clinical trial aims to assess the safety around the time of surgery and the effectiveness over five years of the BAO-G technique in repairing complex aortic aneurysms. The study seeks to provide evidence to guide future treatment choices for patients with this condition. Participants will receive the BAO-G procedure, which uses off-the-shelf iliac branched devices to reconstruct the visceral branches during endovascular repair of thoracoabdominal aortic aneurysms. The study includes one group undergoing this experimental procedure. The primary outcomes measured are the rates of technical success within 30 days after surgery and clinical success within five years postoperatively. During the study, participants will be closely monitored for various outcomes including aneurysm-related death, aneurysm rupture, neurological complications, kidney failure, bowel ischemia, stroke, blood loss during surgery, vascular access issues, operative time, hospital stay length, stent-related complications, and need for reoperation. These assessments will take place during the operation and at regular intervals up to five years after surgery to evaluate both short-term safety and long-term effectiveness.
CONDITIONS
Brief 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 using commercially available iliac branch devices for visceral artery reconstruction
- Signed informed consent and agreed to follow the study protocol for follow-up
You will not qualify if you...
- Acquired 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 organ failure or malignancy diagnosed within 5 years likely to cause mortality during follow-up
- Active bleeding or blood clotting disorders within 6 months
- Uncontrolled high blood pressure (resting systolic >180 mmHg or diastolic >110 mmHg)
- Uncontrolled diabetes with fasting blood glucose >16.7 mmol/L
- Severe liver or kidney 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
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - During the operation and hospital stay
Participants undergo the BAO-G technique using the G-iliac system to reconstruct the visceral branches during endovascular repair of thoracoabdominal aortic aneurysm.
1 surgical procedure and inpatient hospital stay
Duration - Up to 5 years postoperatively
Participants are monitored for clinical success and potential complications for up to 5 years after the procedure.
Regular follow-up visits over 5 years
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
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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
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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
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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