Anatomopathological Analysis and Clinical Evolution After Radiological Removal of Retrievable Vena Cava Filters
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- Correlation between presence of intrafilter thrombi identified by anatomopathologist at the time of retrievable inferior vena cava filters (IVCF) and the occurrence of a venous thromboembolism event within 3 months following removal.
研究概览
简要总结
Pulmonary embolism (PE) is a common pathology causing significant morbidity and mortality. It is usually secondary to migration through the inferior vena cava (IVC) of a formed thrombus in the veins of the lower limbs or pelvis. The inferior vena cava filter (IVCF) is a medical device whose purpose is to prevent thrombus migration from the veins of the legs and pelvis to the pulmonary arteries, thus preventing the occurrence of Pulmonary embolism (PE).
There is no data on the interactions of Retrievable inferior vena cava filters (IVCF) with the inferior vena cava (intrafilter thrombi, insertion through the venous wall) although it may modify the evolution after IVCF retrievable.
详细描述
The main objective of this study is to determine whether the presence of intrafilter thrombi identified by anatomopathology at the time of inferior vena cava filters (IVCF) retrievable was associated with the occurrence of a venous thromboembolism event within 3 months following removal.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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 with a Inferior Vena Cava Filters (IVCF) placed because of temporary contraindication to curative anticoagulation and that was removed by the radiology department at the University Hospital of Saint-Etienne
排除标准
- •Patients included in the PREPIC 2 study
- •Patients whose basement filter had not been removed (difficult removal with surgery, no indication for removal).
结局指标
主要结局
Correlation between presence of intrafilter thrombi identified by anatomopathologist at the time of retrievable inferior vena cava filters (IVCF) and the occurrence of a venous thromboembolism event within 3 months following removal.
时间窗: 3 months
Presence of intrafilter thrombi is measure by anatomopathology analysis of the Inferior Vena Cava Filters (IVCF). Venous thromboembolism events are either deep venous thrombosis (DVT) of the lower limbs (diagnosed by Doppler ultrasonography of the lower limbs) or pulmonary embolism (PE) (diagnosed by chest angio-computed tomography).
次要结局
- Correlation between presence of vascular wall fragments and venous thromboembolism event or death within 3 months following removal.(3 months)
- Correlation between a high tilt of the Inferior Vena Cava Filters (IVCF) and the occurrence of thromboembolic events within the 3 months following the removal of the Inferior Vena Cava Filters (IVCF)(3 months)