NCT02186223已完成不适用
The Angel® Catheter Clinical Trial: Prevention of Pulmonary Embolism in High Risk Subjects
BiO2 Medical41 个研究点 分布在 1 个国家目标入组 172 人开始时间: 2015年1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
- 172
- 试验地点
- 41
- 主要终点
- Freedom From Clinically Significant PE or Fatal PE During Treatment Period
研究概览
简要总结
The primary objective of this multicenter, prospective, single arm clinical trial is to evaluate the safety and effectiveness of the Angel® Catheter in subjects at high risk of PE, and with recognized contraindications to standard pharmacological therapy (anticoagulation).
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
- •Subject or legally authorized representative is willing and able to provide written informed consent,
- •Subject is 18 years or older,
- •Subject is expected to remain in a critical care setting for at least 72 hours,
- •AND at least one of the following inclusion criteria (4,5, and/or 6)
- •Subject has recognized contraindications to standard pharmacological thromboprophylaxis including:
- •Active bleeding or at high risk for bleeding OR
- •Hypersensitivity to pharmacological thromboprophylaxis OR
- •History of severe heparin induced thrombocytopenia OR
- •Severe thrombocytopenia
- •Subject has a confirmed acute proximal lower extremities DVT or a confirmed acute PE with recognized contraindication to anticoagulation
- •Subject requires a temporary interruption (>24 hours) of pharmacological thromboprophylaxis for a surgical or medical procedure
排除标准
- •Subject is pregnant
- •Subject is in treatment with an investigational drug or device within 30 days prior to enrollment
- •Subject has a pre-existing IVC filter in place
- •BMI = > 45
- •Subject has functioning pelvic renal allograft on the only side available for device insertion
- •Subject has undergone a surgical procedure involving the femoral vein or pelvic veins through which the device must be inserted
- •Anatomic inability to place the Angel® Catheter
- •Subject has known hypersensitivity to any of the components of the Angel® Catheter, specifically Nitinol (nickel and/or titanium)
结局指标
主要结局
Freedom From Clinically Significant PE or Fatal PE During Treatment Period
时间窗: Assessed daily from Baseline through Study Exit which occurs 3 days post-Angel Catheter Removal OR at hospital discharge, whichever is first (maximum of 33 assessment days with an anticipated average of 7 days)
1. Clinically Significant PE: Subjects will be assessed daily for signs and symptoms of PE. If present and no alternative diagnosis is suspected, at least one of four defined diagnostic examinations will performed to confirm or rule out PE. 2. Fatal PE: Defined as unexpected death within 24 hours of onset of the acute event with a verified initial symptomatic DVT or PE where there is no other reasonable cause of death.
次要结局
- Incidence of Acute Proximal Deep Vein Thrombosis(Assessed daily from Baseline through Study Exit which occurs 3 days post-Angel Catheter Removal OR at hospital discharge, whichever occurs first (maximum of 33 assessment days with an anticipated average of 7 days))
- Incidence of Catheter Related Thrombosis(Assessed daily from Baseline through Study Exit which occurs 3 days post-Angel Catheter Removal OR at hospital discharge, whichever occurs first (maximum of 33 assessment days with an anticipated average of 7 days))
- Incidence of Catheter Related Blood Stream Infections(Assessed daily from Baseline through Study Exit which occurs 3 days post-Angel Catheter Removal OR at hospital discharge, whichever occurs first (maximum of 33 assessment days with an anticipated average of 7 days))
- Incidence of Major Bleeding Event(Assessed daily from Baseline through Study Exit which occurs 3 days post-Angel Catheter Removal OR at hospital discharge, whichever occurs first (maximum of 33 assessment days with an anticipated average of 7 days))
- Incidence of PEs Averted(During the pre-removal cavogram (An average of 6.8 days after device insertion))
研究者
研究点 (41)
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