FLowTriever for Acute Massive Pulmonary Embolism (FLAME)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 115
- 试验地点
- 11
- 主要终点
- Composite Incidence of All-cause Mortality, Clinical Deterioration, Bailout, and Major Bleeding
研究概览
简要总结
To evaluate treatment outcomes of patients diagnosed with high-risk (massive) pulmonary embolism
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 Treatment team determines pulmonary embolism is the cause of shock, and the PE is high-risk per the protocol definitions
排除标准
- •Out of hospital cardiac arrest with Glasgow Coma Scale of ≤8
- •Witnessed cardiac arrest with ongoing CPR >30 minutes
- •Contraindication to anticoagulants, i.e. heparin or alternative
- •Hematocrit <28%
- •Platelets <25,000/μL
- •Intracardiac thrombus and/or intracardiac clot in transit
- •Known anaphylactic sensitivity to radiographic agents that cannot be pre-treated
- •History of pulmonary hypertension with systolic pulmonary arterial pressure >70 mmHg
- •Presence of chronic medical conditions with estimated < 90 days life expectancy per physician discretion (should not consider the current pulmonary embolism and its treatment)
- •Current participation in another drug or device treatment study that, in the Investigator's opinion, would interfere with participation in this study
- •Patient is known to be COVID-19 positive at hospital admission (patient has active COVID-19)
结局指标
主要结局
Composite Incidence of All-cause Mortality, Clinical Deterioration, Bailout, and Major Bleeding
时间窗: From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first.
The primary endpoint is the in-hospital composite endpoint of all-cause mortality, bailout to an alternative thrombus removal strategy, clinical deterioration, and major bleeding (BARC 3b/3c/5a/5b definition). The primary endpoint was assessed in the FlowTriever Arm compared to a pre-specified performance goal of 32%. Subjects in the Context Arm were analyzed separately using descriptive methods. The primary endpoint in the Context Arm was not compared to a performance goal. Data collection for Prior Therapy Arm subjects included information surrounding the PE treatment, progression to High-Risk PE, and patient course through hospital discharge. Safety data were collected, but not CEC adjudicated or analyzed as outlined for the FlowTriever and Context Arm subjects.
次要结局
- All-Cause Mortality(From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first.)
- Bailout to an Alternative Thrombus Removal Strategy(From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first.)
- Clinical Deterioration(From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first.)
- Major Bleeding(From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first.)
- Frequency of Stroke(From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first.)
- Device-related Complications(From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first.)
- Access Site Injury Requiring Intervention, Both Venous and Arterial(From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first.)