NCT00196118已完成4 期
A Non-Randomized Prospective Study of IVC Filter Retrieval
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 800
- 试验地点
- 34
- 主要终点
- The rate of successful filter retrieval following implant.
研究概览
简要总结
The purpose of this study is to test the hypothesis that the Günther Tulip Vena Cava Filter can be removed after a period of implantation, when implanted in patients for the prevention of pulmonary thromboembolism.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Patient must be considered at high risk for PE, but placement of a permanent IVC filter is not likely to be required.
- •Patient must have a patent internal jugular vein.
- •Patient has given informed consent.
排除标准
- •Patient is less than 18 years.
- •Patient has a pre-existing filter
- •Patient had indications for a permanent filter at the time of the initial evaluation.
- •Patient has uncontrollable coagulopathy.
- •Patient has a short life expectancy < 6 months.
- •Patient has metastatic malignancy.
- •Patient has a vena cava diameter over 30 mm, measured by vena cava sizing catheters.
- •Patient has a contrast allergy that cannot be adequately pre-medicated.
- •Patient is at risk of septic embolism.
- •Patient has sepsis.
- •Patient has a hypersensitivity to any of the components of the GT filter, specifically cobalt, nickel, and chromium.
- •Patient has impaired renal function (creatinine > 2.0).
- •Patient is pregnant or planning to become pregnant within the next 6 months
结局指标
主要结局
The rate of successful filter retrieval following implant.
次要结局
- The rate of complications related to Inferior Vena Cava Filter use.
研究者
研究点 (34)
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