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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Enrolling; Phase 1

Conditions: Complex Aortic Aneurysms; Endovascular Repair; Thoracoabdominal Aortic Aneurysm

Treatments: Procedure: BAO-G

Study type: Interventional

Funder types: Other

Identifiers

NCT07141251

BAO-G-02

Details and patient eligibility

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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
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

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. 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

BAO-G group

Experimental group

Treatment:

Procedure: BAO-G