European Angel® Catheter Post Market Registry
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 2,000
- 试验地点
- 5
- 主要终点
- Rate of averted PE
研究概览
简要总结
This is a post-market, observational, retrospective multi-center Registry designed to gather information on the performance of the Angel® Catheter in general clinical practice.
详细描述
The Registry population will include all consecutive patients in whom the Angel® Catheter is placed at participating sites. Information about the use of the catheter will be collected from placement through three days after device removal, or through death or discharge, whichever occurs first. Date of discharge/transfer from the Critical Care Unit will also be collected, completing the defined registry observation.
Information on up to 2,000 patients will be abstracted from a patient chart review. Sites will be asked to record data on all Angel® Catheter placements in their institution starting with their first Angel® Catheter placement after training by BiO2 Medical, Inc. personnel once all necessary institutional approvals are obtained confirming that Informed Consent is not required from the patient or LAR to collect, use, or publish patient data from this registry.
The registry population will include all consecutive patients in whom the Angel® Catheter is placed, or there has been an attempt to place, at selected Registry sites. The Instructions for Use (IFU) for the Angel® Catheter include the following indications:
- Pulmonary thromboembolism when anticoagulants are contraindicated; or
- Failure of anticoagulant therapy in thromboembolic diseases; or
- Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced; and or
- Critically ill patients at high risk of pulmonary embolism, not receiving medical thromboprophylaxis due to either increased risk of bleeding, active bleeding or heparin induced thrombocytopenia.
Since the Angel® Catheter is indicated for use in pregnant patients, patients who are pregnant may be included in this Registry after the proper risks and benefits have been assessed by the physician.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
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
- •All consecutive patients in whom the Angel® Catheter is placed, or there has been an attempt to place.
排除标准
- 未提供
结局指标
主要结局
Rate of averted PE
时间窗: At the time of the pre-removal cavogram
次要结局
- Incidence and seriousness of deep vein thrombosis(From device placement through hospital discharge, death, or 3 days post-removal, whichever occurs first (Up to 33 days))
- Incidence and seriousness of catheter-related thrombosis(From device placement through removal (Up to 30 days))
- Incidence and seriousness of clinically significant PE(From device placement through hospital discharge, death, or 3 days post-removal, whichever occurs first (Up to 33 days))
- Incidence and seriousness of all device-related adverse events(While the Angel Catheter is in place, including the insertion and removal procedures (Up to 30 days))