NCT00488865已完成不适用
RexMedical- Option* Vena Cava Filter IDE Study
Rex Medical19 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2006年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 19
- 主要终点
- Percentage of Participants With Clinical Success
研究概览
简要总结
This study is designed to evaluate the safety and efficacy of the RexMedical Option* Vena Cava Filter in the treatment of patients who are at increased risk for Pulmonary Embolism and require caval interruption.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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 is at least 18 years of age
- •Patient requires temporary or permanent caval interruption
排除标准
- •Patient has pre-existing filter implanted in her/her vasculature or has undergone filter retrieval within 60 days prior to study device implant
- •Patient is currently enrolled in another investigational device or drug trial
结局指标
主要结局
Percentage of Participants With Clinical Success
时间窗: up to 180 days
Placement Technical Success without subsequent pulmonary embolism, significant filter migration, symptomatic caval thrombosis or other complication requiring filter removal or invasive intervention to address condition.
Percentage of Participants With Retrieval Clinical Success
时间窗: upto 175 days
Intact filter retrieval via percutaneous techniques from the vasculature without associated injury or damage to the vena cava requiring intervention.
次要结局
- Placement Technical Success(Immediately post placement procedure)
研究者
研究点 (19)
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