BAO-G technique for repairing complex thoracoabdominal and abdominal aortic aneurysms

Multicenter, Open-labeled, Single-arm Clinical Trial of Multi-Branch AOrtic Reconstruction of Complex Aortic Aneurysm With G-iliac System [BAO-G] Technique

This study will try the BAO-G endovascular technique, which uses off-the-shelf iliac branched devices to rebuild visceral branches in patients with complex thoracoabdominal or abdominal aortic aneurysms who are candidates for endovascular repair.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Peking Union Medical College Hospital (other)
• Locations: 11 sites (Beijing, Beijing Municipality and 10 other locations)
• Trial ID: NCT07141251 on ClinicalTrials.gov

What this trial studies

This is a prospective, multicenter, open-label, single-arm Phase 1 study testing the perioperative safety and 5-year outcomes of the BAO-G technique for complex aortic aneurysm repair. The technique repurposes commercially available iliac-branched devices to reconstruct visceral arteries and create a multi-branch aortic reconstruction. Eligible patients have Crawford type III-IV thoracoabdominal or complex abdominal aneurysms with a suitable proximal landing zone and are scheduled for endovascular repair. Investigators will follow patients perioperatively and at defined intervals for up to five years to monitor safety, device performance, branch patency, and aneurysm-related outcomes.

Who should consider this trial

Good fit: Adults with Crawford type III-IV thoracoabdominal or complex abdominal aortic aneurysms, a healthy proximal landing zone and anatomy suitable for iliac-branched device reconstruction who can give informed consent and attend follow-up are ideal candidates.

Not a fit: Patients with prior aortic stent-grafts or prosthetic grafts, uncontrolled autoimmune disease, end-stage organ failure, recent major bleeding/coagulopathy, or inability to consent are unlikely to benefit from this approach.

Why it matters

Potential benefit: If successful, BAO-G could offer a less invasive option that preserves blood flow to visceral arteries and may reduce morbidity compared with open repair for selected complex aneurysm patients.

How similar studies have performed: Using iliac-branched devices for visceral branch reconstruction is a novel application; while off-the-shelf branched and fenestrated techniques have some supporting data, this specific BAO-G approach is largely untested beyond small series.

Eligibility criteria

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

Where this trial is running

Beijing, Beijing Municipality and 10 other locations

• Beijing Anzhen Hospital, Capital Medical University — Beijing, Beijing Municipality, China (RECRUITING)
• Fuwai Hospital, CAMS&PUMC — Beijing, Beijing Municipality, China (RECRUITING)
• Peking Union Medical College Hospital — Beijing, Beijing Municipality, China (RECRUITING)
• The First Affiliated Hospital of Chongqing Medical University — Chongqing, Chongqing Municipality, China (RECRUITING)
• The First Affiliated Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China (RECRUITING)
• Hainan General Hospital — Haikou, Hainan, China (RECRUITING)
• The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (RECRUITING)
• The Affiliated Hospital of Jining Medical University — Jining, Shandong, China (RECRUITING)
• Zhongshan Hospital, Fudan University — Shanghai, Shanghai Municipality, China (RECRUITING)
• Renji Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai Municipality, China (RECRUITING)
• Changhai Hospital — Shanghai, Shanghai Municipality, China (RECRUITING)

Study contacts

• Study coordinator: Bao Liu

Conditions: Thoracoabdominal Aortic Aneurysm, Endovascular Repair, Complex Aortic Aneurysms, BAO-G technique, iliac-branched devices, endovascular repair, complex aortic aneurysm