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

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

Sex: All

Ages: 18 Years – 80 Years

Healthy volunteers: No

Phase: NA

Enrollment: 60

Sponsor: Peking Union Medical College Hospital

Location: Beijing Anzhen Hospital, Capital Medical University Beijing Beijing Municipality

Summary

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.

Eligibility Criteria

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 \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

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07141251). StuddyBuddy aggregates publicly available trial information.