Inferior Vena Cava Retrievable Filters: Spanish Register (REFiVeC)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 6
- 主要终点
- Success of retrieval
研究概览
简要总结
Spanish registry of retrievable vena cava filters.
This registry is sponsored by the Spanish Society of Vascular and Interventional Radiology (SERVEI) and conducted by the Research Group GITMI (Group of Research in Minimally Invasive Techniques) of the University of Zaragoza (Spain).
A software tool hosted on the official website of SERVEI and the journal Intervencionismo will be used for data collection a(https://estudios.watsoncme.com).
详细描述
This is an prospective observational study of patients that have been implanted a inferior vena cava filter with intention to be retrieved.
Patients are recruited when the filter is implanted, and the investigators observe when is it finally retrieved (dwell time), if retrieval is possible or not, and if there is any complication at the retrieval of the filter.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Indicated inferior vena cava filter implantation
- •Signed informed consent
排除标准
- •Permanent filters (including retrievable filters intended to be used as permanent ones)
- •Impossibility of follow-up (3, 6 and 12 months)
- •Life expectancy less than a year
- •Patient refusal to be included in the study, at any time
结局指标
主要结局
Success of retrieval
时间窗: 12 months
The primary outcome of this study is to verify if the filter can be retrieved on the scheduled day of retrieval (yes/no).
次要结局
- Dwell time(12 months)
- Complications in retrieval(12 months)
- Overall adverse events(12 months)