NCT00654979已完成不适用
A Pivotal Study to Evaluate the Safety and Effectiveness of RMT Medical Technology's SafeFlo® Vena Cava Filter
RMT Medical Technologies, Ltd.8 个研究点 分布在 6 个国家目标入组 117 人开始时间: 2003年7月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 117
- 试验地点
- 8
- 主要终点
- Clinical success will be defined as no occurrences of any of the following events: recurrent pulmonary embolism, IVC occlusion or filter embolization.
研究概览
简要总结
To determine the safety and effectiveness of the SafeFlo filter for permanent protection against pulmonary emboli. All patients will be selected to receive the filter according to the stated inclusion / exclusion criteria after consultation between the attending physician and interventional radiologist. Patients with a permanent implantation will be followed for up to 6 months. Clinical success will be defined as no occurrences of any of the following events: recurrent pulmonary embolism, IVC occlusion or filter embolization. The proportion of permanent filter patients considered to be a clinical success will be the primary efficacy parameter.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Traditional indications for vena cava filter in patients with established DVT or PE, including (40):
- •Patients with proven Pulmonary Embolus (PE) or Deep Vein Thrombosis (DVT) and one or more of the following:
- •Contraindication to anticoagulation
- •Complication of anticoagulation
- •Failure of anticoagulation
- •Recurrent PE despite adequate anticoagulation therapy
- •Inability to achieve adequate anticoagulation
- •Poor compliance with anticoagulation medications
- •Extended indications for vena cava filter placement in patients with established DVT or PE, including the following (31, 40):
- •Large free-floating thrombus in the iliac vein or IVC;
- •Following massive PE in which recurrent emboli may prove fatal;
- •During/after surgical or transcatheter embolectomy;
- •Filter placement in high-risk trauma and orthopedic patients:
- •High risk trauma or orthopedic patients who cannot receive anticoagulation because of increased bleeding risk, and have one or more of the following injury patterns (31, 40):
- •Severe closed head injury (GCS < 8);
- •Incomplete spinal cord injury with para or quadriplegia;
- •Complex pelvic fractures with associated long-bone fractures;
- •Multiple long bone fractures.
- •Patients undergoing long-term immobilization (e.g., ICU or Surgical oncology)
排除标准
- •All patients under 18 years of age.
- •All patients undergoing emergency procedures.
- •All patients with abnormal IVC anatomy or pathology of the IVC such as thrombosis or tumor which prevent safe filter implantation.
- •All patients with an IVC diameter which precludes oversizing of the filter platform.
- •All patients with active infection / bacteremia.
- •All patients with sensitivity to contrast media.
- •Uncorrectable severe coagulopathy (e.g., patients with liver or multisystem failure).
研究组 & 干预措施
Single arm
Experimental
SafeFlo IVC Filter
干预措施: SafeFlo IVC Filter (Device)
结局指标
主要结局
Clinical success will be defined as no occurrences of any of the following events: recurrent pulmonary embolism, IVC occlusion or filter embolization.
时间窗: 6 months follow-up
次要结局
- The proportion of patients with successful deployment of the filter will be calculated and presented with a 95% exact confidence interval.(3 and 6 months follow-up)
研究者
研究点 (8)
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