Clinical Trial of BAO-G Technique in Complex Aortic Aneurysm Endovascular Repair (BAO-G-02)
NCT ID: NCT07141251
Last Updated: 2025-09-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
60 participants
INTERVENTIONAL
2022-01-01
2035-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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BAO-G group
BAO-G
Using G-iliac system to reconstruct the visceral branches of in endovascular repair of thoracoabdominal aortic aneurysm.
Interventions
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BAO-G
Using G-iliac system to reconstruct the visceral branches of in endovascular repair of thoracoabdominal aortic aneurysm.
Eligibility Criteria
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Inclusion Criteria
2. Scheduled for endovascular aortic repair with commercially available iliac branch devices for visceral artery reconstruction
3. Signed informed consent and committed to protocol-defined follow-up
Exclusion Criteria
2. Uncontrolled autoimmune diseases (e.g., Takayasu arteritis, systemic lupus erythematosus, vasculitis)
3. Prior aortic surgery with stent-graft or prosthetic vascular graft implantation
4. End-stage renal/hepatic/cardiac/pulmonary failure or malignancy diagnosed within 5 years, likely to cause mortality during follow-up
5. Active bleeding or coagulopathy within 6 months (high bleeding risk)
6. Uncontrolled hypertension (resting SBP \>180 mmHg or DBP \>110 mmHg)
7. Uncontrolled diabetes (fasting blood glucose \>16.7 mmol/L)
8. Severe hepatic/renal dysfunction (serum creatinine \>3 mg/dL, ALT/AST \>3×ULN)
9. Concurrent participation in other interventional clinical trials
10. Pregnancy or perinatal status
11. Refusal to sign informed consent
18 Years
80 Years
ALL
No
Sponsors
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Fudan University
OTHER
First Affiliated Hospital, Sun Yat-Sen University
OTHER
Changhai Hospital
OTHER
Chinese Academy of Medical Sciences, Fuwai Hospital
OTHER
Beijing Anzhen Hospital
OTHER
RenJi Hospital
OTHER
Hainan General Hospital
OTHER
The First Affiliated Hospital of Zhengzhou University
OTHER
First Affiliated Hospital of Chongqing Medical University
OTHER
The Affiliated Hospital of Jining Medical University
UNKNOWN
Peking Union Medical College Hospital
OTHER
Responsible Party
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Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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BAO-G-02
Identifier Type: -
Identifier Source: org_study_id
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