NCT01120522已完成3 期
Crux Biomedical Evaluation of the Crux Inferior Vena Cava Filter System 3
Crux Biomedical2 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2010年5月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Clinical Success
研究概览
简要总结
The purpose of this study is to determine if the Crux Vena Cava Filter System is safe and effective in preventing pulmonary embolism.
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
- •Patient has a permanent or temporary risk of Pulmonary Embolism.
- •Patient must provide informed consent At least one of the following conditions -
- •Proven PE
- •Recurrent PE despite adequate
- •Contraindication to anticoagulation
- •Inability to achieve/maintain therapeutic anticoagulation
- •Iliocaval DVT
- •Large, free-floating proximal DVT
- •Massive PE treated with thrombolysis/thrombectomy
- •Chronic PE treated with thrombectomy
- •Protection during thrombolysis for iliocaval DVT
- •PE with limited cardiopulmonary reserve
- •Poor compliance with anticoagulation medication
- •High risk of injury worsening on anticoagulation
- •Multi-trauma patient with high risk of PE
- •Surgical patients at high risk of PE
- •Medical condition with high risk of PE Patients with a documented vena cava diameter of 17-28mm Patient has IVC anatomy suitable for infra-renal placement Patient is willing to be available for the appropriate follow up
排除标准
- •Age <18 years old
- •Patient has any one of the following conditions:
- •Renal vein thrombosis
- •IVC thrombosis extending to the renal veins
- •Duplicate IVC
- •Gonadal vein thrombosis
- •Requires supra-renal placement
- •Vena cava diameter of 17-28mm
- •Uncontrolled infectious disease
- •Risk of aseptic PE
- •Uncontrolled coagulopathy
- •Existing inferior vena cava filter implant
- •Life expectancy less than 6 months
- •Pregnant or planning a pregnancy in the next 6 months
- •Condition that inhibits radiographic visualization of the IVC
- •Known allergy or intolerance to polytetrafluoroethylene (PTFE) or Nitinol
- •Known hypersensitivity to contract which cannot be pretreated
- •Access vessels preclude same insertion of delivery system
- •Participation in another drug or device trial
- •Unable or unwilling to cooperate with study procedures or required follow-up visits
结局指标
主要结局
Clinical Success
时间窗: 6 Months
Clinical Success is a composite endpoint consisting of technical success with freedom from pulmonary embolism, filter migration and device related events requiring intervention.
次要结局
- Retrieval Success(6 months)
- Filter Migration(6 Months)
- VCF Thrombus(6 Months)
- Device Integrity(6 Months)
研究者
研究点 (2)
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