Pilot Study of Multi-Branch AOrtic Reconstruction With G-iliac System (BAO-G) Technique in Thoracoabdominal Aortic Aneurysm Endovascular Repair
Overview
- Phase
- Early Phase 1
- Status
- Enrolling By Invitation
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Rate of visceral branch patency
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with TAAA, confirmed by aortic CTA.
- •TAAA diameter ≥ 6cm, or symptomatic TAAA with diameter ≥ 4cm.
- •Informed consent signed.
Exclusion Criteria
- •were pregnant.
- •had a history of previous endovascular or open repair.
- •had other contraindications of endovascular treatment.
- •Uncontrolled autoimmune disease.
Outcomes
Primary Outcomes
Rate of visceral branch patency
Time Frame: Month 0, 3, 6, 12, and annually after surgery
the patency of visceral branches measured by radiological test
Incidence of endoleak
Time Frame: Month 0, 3, 6, 12, and annually after surgery
The incidence of endoleak measured by radiological test
Incidence of re-operation
Time Frame: 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 Outcomes
- Incidence of acute liver function injury(perioperative period)
- Incidence of acute pancreatitis(perioperative period)
- Incidence of organ ischemia(Month 0, 3, 6, 12, and annually after surgery)
- Incidence of acute kidney injury(perioperative period)
Investigators
Liu Bao
Professor
Peking Union Medical College Hospital