NCT00470626已完成不适用
Prospective Study of the Cook Celect Filter, Including Permanent and Retrievable Use
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 129
- 试验地点
- 16
- 主要终点
- Major Adverse Event
研究概览
简要总结
The clinical study will collect data to verify the safety and performance of the Cook Celect Filter in the prevention of pulmonary embolism (PE) in patients with a temporary or permanent high risk of 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 high risk for pulmonary embolism and is under consideration for placement of a permanent or short-term IVC filter.
- •The patient must have a patent internal jugular vein.
- •The patient or guardian must have given informed consent.
- •The patient must agree to return for clinical imaging follow-up at 1, 3, 6, and 12 months.
- •The patient must agree to have a clinical and imaging examination performed prior to filter retrieval.
- •The patient must agree to return for clinical and imaging follow-up at 30 days and 3 months after filter retrieval.
排除标准
- •The patient is less than 18 years of age.
- •The patient is pregnant.
- •The patient has uncontrollable coagulopathy.
- •The patient has a life expectancy less than 6 months.
- •The patient has a vena cava diameter over 30 mm, measured by vena cava sizing catheters.
- •The patient's vena cava diameter is less than 15 mm, measured by vena cava sizing catheters.
- •The patient has a contrast allergy that can not be adequately pre-medicated.
- •The patient is simultaneously participating in another investigative drug or device study, or has a previous IVC filter.
结局指标
主要结局
Major Adverse Event
时间窗: up to 12 months
Composite Major Adverse Event includes hemorrhage, perforation, pulmonary embolism, procedure-related or device-related death, occlusion, significant migration and filter fracture.
次要结局
- Successful Retrieval(up to 12 months)
- Mean Time to Retrieval Attempt(up to 12 months)
研究者
研究点 (16)
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