The Bard® Recovery® Filter Registry (EVEREST) for Patients Who Are Candidates for an Optional (Retrievable) Inferior Vena Cava Filter That Undergo Placement of the Bard® Recovery® Filter.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 主要终点
- Technical Success (Retrieval)
研究概览
简要总结
This study was designed to assess the safety of retrieval of the Bard Recovery® G2® Filter System. The G2 filter is an FDA-cleared device for inferior vena caval interruption in patients with pulmonary thromboembolism.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient is at temporary , increased risk of pulmonary embolism requiring caval interruption
排除标准
- •The patient has implanted filter in the IVC or superior vena cava (SVC)
- •The patient has a duplicated or left-sided IVC
- •The patient has a known untreatable or uncontrollable malignancy
- •The patient has severe spinal deformity
- •The patient has a creatinine > 2.0 mg/dl
- •The patient has a life expectancy of < 6 months
结局指标
主要结局
Technical Success (Retrieval)
时间窗: 1 month post filter retrieval or through 6 months following implantation
Technical success for retrieval of the filter such that the entire filter is removed.
Clinical Success (Retrieval)
时间窗: Time of Retrieval or through 6 months of implantation
technical success without subsequent damage to the cava wall or other retrieval-related complications requiring intervention.
Percentage of Participants With Adverse Events Through 30 Days Post Retrieval
时间窗: 30 days post retrieval
Adverse events occurring at the time of retrieval through 30 days post filter retrieval procedure
次要结局
- Filter Migration > 2cm(30 days post retrieval or 6 months following filter placement)
- Incidence of Filter Fracture(at 6 months or at retrieval of the filter)