NCT01403090已完成1 期
A Single Treatment, Open Label, Multicenter, Safety Study of the Angel™ Catheter in Hospitalized Human Subjects With a Temporary Risk of Pulmonary Embolism
BiO2 Medical2 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2011年12月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Safety
研究概览
简要总结
The Angel™ Catheter combines the functions of a vena cava filter and a multi-lumen central line catheter. The device is designed to be placed in the inferior vena cava via the femoral vein for the prevention of Pulmonary Embolism (PE) and for access to the central venous system. The primary endpoint is freedom from serious adverse events (SAE), defined as death, symptomatic pulmonary embolism or major bleeding .
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 is 18 years and older
- •Be admitted to the hospital
- •One of the following two criteria:
- •Patients with proven deep vein thrombosis (DVT) or pulmonary embolism ( PE), at high risk for pulmonary embolism and under consideration for insertion of a retrievable inferior vena cava (IVC) filter with at least one of the following criteria:
- •Contraindications for anticoagulation
- •Recurrent PE despite adequate anticoagulation
- •Emergency treatment following massive pulmonary embolism
- •Patients at high risk for developing PE who require but have a temporary or absolute contraindication for prophylaxis with anticoagulation, including:
- •Patients with multiple trauma and active or recent bleeding with contraindications to anticoagulation or that require a temporary stop of anticoagulation
- •severe head injury with coma
- •severe hemorrhagic stroke with coma
- •head injury with a long bone fracture
- •spinal cord injury with paraplegia or quadriplegia
- •multiple (≥2) long bone fractures with pelvic fracture
- •multiple (≥4) long bone fractures
- •Critically ill patients in the Medical or Surgical Intensive Care Unit with high risk of PE that require but are contraindicated for anticoagulation prophylaxis and will benefit from a temporary filter and a central venous access catheter
- •Patients who had recently undergone or are about to undergo a surgical procedure that requires temporary interruption of anticoagulation for Venous Thromboembolism (VTE) and will benefit from a temporary vena cava filter and central
排除标准
- •Patient is less than 18 years
- •Patient is pregnant or has a positive serum human chorionic gonadotropin (HCG) pregnancy test at baseline visit
- •Patient or next legal representative cannot give informed consent
- •Patients with anticipated survival < 2 days (catastrophic illness)
- •Body mass index greater than 35
- •Patient has a pre-existing filter
- •Participation in another simultaneous interventional medical investigation or interventional trial.
- •Patient has indications for a permanent filter at the time of the initial evaluation
- •Patient has an uncontrollable coagulopathy with active bleeding.
- •Patient with proven endocarditis or bacteremia
- •Patient has hypersensitivity to any of the components of the Angel™ Catheter, specifically Nitinol
- •Known acute or chronic thrombotic occlusion of both common femoral veins or iliac veins
- •Patient with functioning pelvic renal allograft on the only side available for device insertion
- •Patient who will undergo surgical procedure involving the femoral vein or pelvic veins through which the device must be inserted
结局指标
主要结局
Safety
时间窗: 30 days
Device safety was evaluated on the basis of identification and summarization of the incidence rates of complications and adverse effects.
次要结局
未报告次要终点
研究者
研究点 (2)
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