Pilot Study of Multi-Branch AOrtic Reconstruction With G-iliac System (BAO-G) Technique in Thoracoabdominal Aortic Aneurysm Endovascular Repair
试验速览
- 阶段
- 1 期
- 状态
- Enrolling By Invitation
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Rate of visceral branch patency
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with TAAA, confirmed by aortic CTA.
- •TAAA diameter ≥ 6cm, or symptomatic TAAA with diameter ≥ 4cm.
- •Informed consent signed.
排除标准
- •were pregnant.
- •had a history of previous endovascular or open repair.
- •had other contraindications of endovascular treatment.
- •Uncontrolled autoimmune disease.
研究组 & 干预措施
BAO-G group
干预措施: BAO-G (Procedure)
结局指标
主要结局
Rate of visceral branch patency
时间窗: Month 0, 3, 6, 12, and annually after surgery
the patency of visceral branches measured by radiological test
Incidence of endoleak
时间窗: Month 0, 3, 6, 12, and annually after surgery
The incidence of endoleak measured by radiological test
Incidence of re-operation
时间窗: 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
次要结局
- 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)
研究者
Liu Bao
Professor
Peking Union Medical College Hospital