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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Diagnosed with Crawford type Ⅰ- Ⅴ 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. Patients with pseudoaneurysms, post-dissection aneurysmal degeneration, or failure of previous EVAR were also eligible if the pathology involved the visceral aortic segment;
3. Scheduled for endovascular aortic repair with commercially available iliac branch devices for visceral artery reconstruction
4. 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. End-stage renal/hepatic/cardiac/pulmonary failure or malignancy diagnosed within 5 years, likely to cause mortality during follow-up
4. Active bleeding or coagulopathy within 6 months (high bleeding risk)
5. Uncontrolled hypertension (resting SBP \>180 mmHg or DBP \>110 mmHg)
6. Uncontrolled diabetes (fasting blood glucose \>16.7 mmol/L)
7. Severe hepatic/renal dysfunction (serum creatinine \>3 mg/dL, ALT/AST \>3×ULN)
8. Concurrent participation in other interventional clinical trials
9. Pregnancy or perinatal status
10. Refusal to sign informed consent

Where it's running

• 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

Study contacts

• Study coordinator: Bao Liu
• Email: liubao7286@163.com
• Phone: +86010-69152592

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.