Outcomes of Mechanical Thrombectomy With the FlowTriever Device in Acute Pulmonary Embolism, Results of a Swedish Retrospective Analysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- Composite endpoint of survival and major bleeding
研究概览
简要总结
International guidelines recommend intravenous thrombolysis (IVT) for high-risk pulmonary embolism (PE). In high-risk PE where IVT is contraindicated or has failed, surgical embolectomy or catheter-directed intervention (CDI) is recommended. CDI is also recommended as an alternative in patients with intermediate-risk PE with haemodynamic deterioration during anticoagulation treatment.
Although there is a lack of randomized studies comparing CDI to anticoagulation or systemic thrombolysis in PE, several studies and recent meta-analyses have shown that CDI is an effective treatment that is associated with fewer complications than IVT, especially bleeding.
详细描述
The FlowTriever® retrieval/aspiration system is the first mechanical thrombectomy device to receive PE as an indication from the United States Food and Drug administration agency. It combines large-bore aspiration with expanding mesh disks designed to trap and subsequently retract the blood clots from the pulmonary arteries. While Inari Medical, the medical device company that produces the FlowTriever® system, has initiated and published a few prospective trials on FlowTriever® in PE, non-industry sponsored studies are small and mostly retrospective.
In 2021 FlowTriever® became the primary device for CDI in PE at Sahlgrenska University Hospital in Gothenburg, Sweden. Concurrently, several hospitals in Sweden have started using FlowTriever® in high-risk PE. As such, the method needs evaluation and validation on a local and national level.
This retrospective observational study aims to evaluate the outcomes of patients with acute PE treated with the FlowTriever® device in Sweden. A control group consisting of PE patients treated with IVT will be used for comparison.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Age ≥18 years
- •Acute PE verified by computed tomography (CT) or angiography
- •PE treated with thrombolysis or FlowTriever® during the time period from January 1st of the year when FlowTriever was introduced at each respective participating center to the end of 2023.
排除标准
- 未提供
研究组 & 干预措施
FlowTriever
Acute PE patients treated with the FlowTriever device
干预措施: Mechanical thrombectomy (Device)
Intravenous Thrombolysis
Acute PE patients treated with intravenous thrombolysis
干预措施: Intravenous thrombolysis (Drug)
结局指标
主要结局
Composite endpoint of survival and major bleeding
时间窗: up to 7 days and up to 30 days
Composite endpoint of survival at 30 days and major bleeding within 7 days, after intervention.
次要结局
- Total Length of stay in hospital(From diagnosis of PE until discharge from hospital, up to 30 days)
- Survival(up to 30 days)
- Major Bleeding(up to 7 days)
- Right Ventricle/Left Ventricle (RV/LV) ratio(from 48 hours before intervention up to 48 hours after intervention)
- Total Length of stay in the ICU or IMCU(From administration until discharge from ICU/IMCU, up to 30 days)
研究者
Kristina Svennerholm
Principal investigator. MD. PhD.
Sahlgrenska University Hospital