Registry on Gore Branch Endoprosthesis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- device stability
研究概览
简要总结
Multicenter registry on patients treated by the new Gore thoracic branched endoprosthesis
详细描述
This is a multicenter, non-sponsored, physician-initiated multicenter registry on patients treated with the Gore thoracic branched endoprosthesis.
Inclusion of centers is on a voluntary basis; each participating center includes consecutive patients treated with this device.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients receving the Gore TAG thoracic branched endograft for thoracic aorta pathologies
排除标准
- •less than 18 years
- •allergy to endograft components
- •patients receiving other types of arch endografts
结局指标
主要结局
device stability
时间窗: 5 years
freedom from related mortality, reintervention, type 1a endoleak during follow-up
technical success
时间窗: 30 days
succesful deployment of all endograft components at the intended site with complete aneurysm exclusion, without surgical conversion, type Ia/III endoleak, kink, stenosis, graft occlusion
early mortality
时间窗: 30 days
mortality related to the intervention within 30 days
次要结局
- early major adverse events(30 days)
研究者
Michele Piazza
MD
University Hospital Padova