Prospective/Retrospective Multicenter Registry to Examine the Real-world Performance in France of the E-vita OPEN PLUS Stent Graft System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- JOTEC GmbH
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Primary endpoint
研究概览
简要总结
The FEOR registry is undertaken to examine the real-world data of patients that were treated with the E-vita OPEN Plus Stent Graft System under routine care in France. This registry is a requirement of the Haute Autorité de Santé (HAS).
详细描述
Data Collection on patients who have been implanted with an E-vita OPEN PLUS Stent Graft System from 15th July 2014 until 31st May 2019. The E-vita OPEN PLUS Stent Graft System was implanted at the discretion of the treating physician. Participating physicians provided their observations collected during routine care for patients he/she had decided to treat with the E-vita OPEN PLUS Stent Graft System.
The period of data collection was three years starting from the intervention of each patient. Data verification was performed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Primary endpoint
时间窗: 30 days
The primary endpoint is a composite endpoint of morbi-mortality defined as following: * Mortality rate * Morbidity rate including neurological complications, visceral malperfusion, and renal complications. Neurological complications comprise new cerebrovascular accident (CVA)/stroke, spinal cord ischemia, paraparesis, paraplegia as reported in the eCRF. Visceral malperfusion includes new bowel obstruction and visceral ischemia/infarction as reported in the eCRF. Renal complications comprise new renal insufficiency and renal insufficiency requiring dialysis as reported in the eCRF.
次要结局
- Adverse Events(3 year)
- Endoleak type IV(3 year)
- Reinterventions(3 year)
- Endoleak type Ib(3 year)
- Endoleak type III(3 year)
- Fully thrombosed false lumen (dissections)(3 year)
- Mortality(3 year)
- Morbidity(3 year)
- Endoleak type II(3 year)
- Secondary interventions(3 year)
- Partially thrombosed false lumen (dissections)(3 year)
- Patent false lumen (dissections)(3 year)