Aortic Aneurysm, Thoracoabdominal
Conditions
Keywords
BAO-G technique, thoracoabdominal aortic aneurysm, iliac-branched devices, endovascular repair
Brief summary
Multi-Branch AOrtic Reconstruction With G-iliac System (BAO-G) Technique is a novel technique of endovascular repair of thoracoabdominal aortic aneurysm, which using off-the-shelf iliac branched devices to reconstruct the visceral branches. This study aims to evaluate the safety and efficacy of BAO-G in thoracoabdominal aortic aneurysm endovascular repair.
Interventions
PROCEDUREBAO-G
Using G-iliac system to reconstruct the visceral branches of in endovascular repair of thoracoabdominal aortic aneurysm.
Sponsors
Peking Union Medical College Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with TAAA, confirmed by aortic CTA. 2. TAAA diameter ≥ 6cm, or symptomatic TAAA with diameter ≥ 4cm. 3. Informed consent signed.
Exclusion criteria
1. were pregnant. 2. had a history of previous endovascular or open repair. 3. had other contraindications of endovascular treatment. 4. Uncontrolled autoimmune disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of visceral branch patency | Month 0, 3, 6, 12, and annually after surgery | the patency of visceral branches measured by radiological test |
| Incidence of endoleak | Month 0, 3, 6, 12, and annually after surgery | The incidence of endoleak measured by radiological test |
| Incidence of re-operation | Month 0, 3, 6, 12, and annually after surgery | The incidence of re-operation for any adverse events, confirmed by medical record and outpatient follow up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of organ ischemia | Month 0, 3, 6, 12, and annually after surgery | Incidence of organ ischemia, measured by physical examination and radiological test |
| Incidence of acute pancreatitis | perioperative period | The incidence of acute pancreatitis, measured by serum amylase level |
| Incidence of acute kidney injury | perioperative period | The incidence of acute kidney injury, measured by serum creatinine level |
| Incidence of acute liver function injury | perioperative period | The incidence of acute liver function injury, measured by serum transaminase level |
Countries
China
Outcome results
None listed