适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 49
- 主要终点
- Composite clinical endpoint of the following adjudicated events:
研究概览
简要总结
Randomized Controlled Trial of High-Risk Pulmonary Embolism Comparing FlowTriever System vs. Standard of Care
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Age at enrollment ≥18 years
- •Objective evidence of a proximal filling defect in at least one main or lobar pulmonary artery
- •High-risk class of acute PE
- •RV dysfunction, as defined RV/LV ratio ≥1.0
- •Willing and able to provide informed consent, or if unable, through a Legal Authorized Representative, with permitting research without prior consent as a third option (for Europe and UK sites only), provided compliance with IRB/EC approvals and adherence to regulatory, ethical and national standards
排除标准
- •Prolonged cardiac arrest with loss of consciousness associated with neurological deficit.
- •Imaging evidence or other evidence that suggests, in the opinion of the Investigator, the patient is not appropriate for catheter-based intervention
- •Known pre-existing CTEPH, or CT signs of chronic PE that may point to pre-existing CTEPH
- •Recent stroke (<14 days)
- •Recent cranial or spinal surgery (<14 days)
- •Life-threatening active bleeding or hemorrhage into a critical area
- •Known intracranial tumor
- •End-stage medical condition with life expectancy <3 months (irrespective of the severity of acute PE), as determined by the Investigator
- •Known sensitivity to radiographic contrast agents that, in the Investigator's opinion, cannot be adequately pre-treated
- •Inability to anticoagulate the patient, or known to have heparin-induced thrombocytopenia (HIT)
- •Current participation in another drug or device study that may interfere with the conduct of this trial
- •Ventricular arrhythmias refractory to treatment at the time of enrollment
- •Subject has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject (e.g., compromise the well-being or that could prevent, limit, or confound the protocol-specified assessments), including a contraindication to use of FlowTriever System per local approved labeling
- •Subject is part of a vulnerable population (e.g., currently pregnant, breastfeeding or incarcerated) per local definitions
- •Subject was previously enrolled in this study
- •Subject has received prior thrombolytic (systemic or catheter-directed) therapy for any reason or thrombectomy (surgical or catheter-based) therapy for index PE, within 30 days prior to randomization
研究组 & 干预措施
FlowTriever
Active Comparator
干预措施: FlowTriever System (Device)
Standard of Care
Active Comparator
干预措施: Standard of Care (Procedure)
结局指标
主要结局
Composite clinical endpoint of the following adjudicated events:
时间窗: The earlier of initial hospital discharge or 7 days after randomization
1. All-cause mortality 2. Cardiac arrest 3. Bailout to an alternative therapeutic strategy 4. Major bleeding 5. ECMO life support
次要结局
- All-cause mortality(At the earlier of initial hospital discharge or 7 days post randomization and at 3-month visit)
- Cardiac arrest(At the earlier of initial hospital discharge or 7 days post randomization)
- Bailout to an alternative therapeutic strategy(At the earlier of initial hospital discharge or 7 days post randomization)
- Major bleeding(At the earlier of initial hospital discharge or 7 days post randomization and at 3-month visit)
- ECMO life support(7 days post-randomization)
- PE-related mortality(3 months)
- All-cause and PE-related readmissions(30 days and 90 days)
- Days alive outside hospital(90 days)
- PE-related quality of life, by PEmb-QoL(3 months)
- General health-related quality of life, by EQ-5D-5L(3 months)
- Post-PE Impairment diagnosis(3 months)
- Change in the RV/LV diastolic diameter ratio (RV/LV) as measured by echocardiography from baseline(72 hours)
研究者
研究点 (49)
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