FlowTriever All-Comer Registry for Patient Safety and Hemodynamics (FLASH)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,200
- 试验地点
- 81
- 主要终点
- Subjects With Major Adverse Events
研究概览
简要总结
To evaluate the safety and effectiveness of the FlowTriever System for use in the removal of emboli from the pulmonary arteries in the treatment of acute pulmonary embolism (PE). The use of the device will be assessed in a real-world population, with eligibility criteria that closely approximate its use in clinical practice.
Up to 300 additional patients with anticoagulation treatment as the initial planned primary treatment strategy for intermediate risk PE will also be evaluated (US only).
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
- •Clinical signs and symptoms consistent with acute PE
- •Echo, CTPA or pulmonary angiographic evidence of proximal filling defect in at least one main or lobar pulmonary artery
- •Scheduled for PE treatment with the FlowTriever System per the Investigator's discretion*
- •US only: Patients enrolled in the Conservative Therapy Sub-study are not required to meet this inclusion criteria but must instead be scheduled for primary anticoagulation therapy as the primary treatment strategy.
排除标准
- •Unable to be anticoagulated with heparin or alternative
- •Diagnosis with a minor PE with a less than 0.9 RV/LV ratio
- •Known sensitivity to radiographic contrast agents that, in the Investigator's opinion, cannot be adequately pre-treated*
- •Imaging evidence or other evidence that suggests, in the Investigator's opinion, the subject is not appropriate for mechanical thrombectomy intervention*
- •Life expectancy < 30 days, as determined by Investigator
- •Current participation in another investigational drug or device treatment study that, in the Investigator's opinion, would interfere with participation in this study
- •US Only Patients enrolled in the Conservative Therapy Sub-study are not required to meet these exclusion criteria
研究组 & 干预措施
FlowTriever
Mechanical thrombectomy for pulmonary embolism
干预措施: FlowTriever System (Device)
Conservative Therapy Sub-Study
Anticoagulation medication for pulmonary embolism (as directed by treating physician)
干预措施: Anticoagulation Agents (Drug)
结局指标
主要结局
Subjects With Major Adverse Events
时间窗: 48-hours after index procedure
MAEs are defined as a composite, when one or more of the following events occur: * Device-related mortality through 48 hours after the index procedure, or * Major bleeding through 48 hours after the index procedure, or * Intra-procedural device-related or procedure-related adverse events, including: * Clinical deterioration defined by hemodynamic or respiratory worsening, or * Device-related pulmonary vascular injury, or * Device-related cardiac injury The components of the composite MAE endpoint were adjudicated by the independent Medical Monitor.
次要结局
- Device-Related Mortality(48-hours after the index procedure)
- Major Bleeding(48 hours after index procedure)
- Intraprocedural Device-related or Procedure-related Adverse Events(Intraprocedural - occurring during the procedure or within 30 minutes of the FlowTriever Catheter being removed from the patient.)