适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 692
- 试验地点
- 116
- 主要终点
- Primary Endpoint: Composite Clinical Endpoint Constructed as a 5-Component Win Ratio
研究概览
简要总结
A prospective, multicenter, randomized controlled trial of the FlowTriever System compared to Catheter-Directed Thrombolysis (CDT) for use in the treatment of acute pulmonary embolism. The trial includes a non-randomized cohort of subjects with an absolute contraindication to thrombolysis.
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
- •Subjects must meet each of the following criteria to be included in the study:
- •Age ≥ 18 years
- •Echo, computed tomographic pulmonary angiography (CTPA), or pulmonary angiographic evidence of any proximal filling defect in at least one main or lobar pulmonary artery
- •Including ALL of the following: Clinical signs and symptoms consistent with acute PE, or PESI class III-V, or sPESI ≥1; AND Hemodynamically stable AND; RV dysfunction on echocardiography or CT; AND Any one or more of the following present at the time of diagnosis: Elevated cardiac troponin levels; History of heart failure; History of chronic lung disease; Heart rate ≥110 beats per minute; SBP <100mmHg; Respiratory rate ≥30 breaths per minute; O2 saturation <90%; Syncope related to PE; Elevated Lactate
- •Intervention planned to begin within 72 hours of the later of either: confirmed PE diagnosis; OR if transferring from another hospital, arrival at the treating hospital
- •Symptom onset within 14 days of confirmed PE diagnosis
排除标准
- •Subjects will be excluded from the study for any of the following criteria:
- •Unable to anticoagulate with heparin, enoxaparin or other parenteral antithrombin
- •Index presentation with hemodynamic instability that are part of the high-risk PE definition in the ESC Guidelines 2019, including ANY of the following: cardiac arrest; OR systolic BP < 90 mmHg or vasopressors required to achieve a BP ≥90 mmHg despite adequate filling status, AND end-organ hypoperfusion; OR systolic BP < 90 mmHg or systolic BP drop ≥40 mmHg, lasting longer than 15 min and not caused by new-onset arrhythmia, hypovolemia, or sepsis
- •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 opinion of the Investigator, the patient is not appropriate for catheter-based intervention (e.g. inability to navigate to target location, clot limited to segmental/subsegmental distribution, predominately chronic clot)
- •Patient has right heart clot in transit identified at baseline screening
- •Life expectancy < 30 days (e.g. stage 4 cancer or severe COVID-19 infection), as determined by the Investigator
- •Current participation in another drug or device study that, in the Investigator's opinion, would interfere with participation in this study
- •Current or history of chronic thromboembolic pulmonary hypertension (CTEPH) or chronic thromboembolic disease (CTED) diagnosis, per ESC 2019 guidelines
- •Invasive systolic PA pressure ≥70 mmHg prior to study device entering the body
- •Administration of bolus or drip/infusion thrombolytic therapy or mechanical thrombectomy for the index PE event within 48 hours prior to enrollment
- •Ventricular arrhythmias refractory to treatment at the time of enrollment
- •Known to have heparin-induced thrombocytopenia (HIT)
- •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). This includes a contraindication to use of FlowTriever or CDT System (for example, EKOS System) per local approved labeling
- •Subject has previously completed or withdrawn from this study
- •Patient unwilling or unable to conduct the follow up visits per protocol.
研究组 & 干预措施
Randomized Controlled Trial Cohort - FlowTriever Arm
Active Comparator
Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.
干预措施: FlowTriever System (Device)
Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm
Active Comparator
Catheter-Directed Thrombolysis for pulmonary embolism (any commercially available CDT system)
干预措施: Catheter-Directed Thrombolysis (Device)
Non-Randomized Absolute Contraindication to Thrombolytics Cohort
Other
Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.
干预措施: FlowTriever System (Device)
结局指标
主要结局
Primary Endpoint: Composite Clinical Endpoint Constructed as a 5-Component Win Ratio
时间窗: Hospital discharge or at 7 days after the index procedure, whichever is sooner
The primary endpoint is a composite constructed as a hierarchical win ratio of the following 5 components: 1. All-cause mortality, or 2. Intracranial hemorrhage (ICH), or 3. Major bleeding per ISTH definition, or 4. Clinical deterioration defined by hemodynamic or respiratory worsening, and/or escalation to a bailout therapy, or 5. ICU admission and ICU length-of-stay during the index hospitalization and following the index procedure. A win ratio larger than 1 indicates that patients who receive treatment with FlowTriever are more likely to have better outcomes as compared to subjects treated with CDT.
次要结局
- Composite Clinical Endpoint Constructed as a 4-Component Win Ratio(Hospital discharge or at 7 days after the index procedure, whichever is sooner)
- All-cause Mortality(Hospital discharge or at 7 days after the index procedure, whichever is sooner)
- Intracranial Hemorrhage (ICH)(Hospital discharge or at 7 days after the index procedure, whichever is sooner)
- Major Bleeding Per ISTH Definition(Hospital discharge or at 7 days after the index procedure, whichever is sooner)
- Clinical Deterioration Defined by Hemodynamic or Respiratory Worsening, and/or Escalation to a Bailout Therapy(Hospital discharge or at 7 days after the index procedure, whichever is sooner)
- ICU Admission During the Index Hospitalization and Following the Index Procedure(Hospital discharge or at 7 days after the index procedure, whichever is sooner)
- ICU Length of Stay During the Index Hospitalization and Following the Index Procedure Among Subjects With ICU Admission.(Hospital discharge or at 7 days after the index procedure, whichever is sooner)
- All Cause Mortality(30 days from index procedure)
- All-cause and PE-related Readmissions(30 days from index procedure)
- Device-related Serious Adverse Events(Through the 30 day visit)
- Drug-related Serious Adverse Events(Through the 30 day visit)
- Clinically Relevant Non-Major (CRNM) and Minor Bleeding Events(Hospital discharge or at 7 days after the index procedure, whichever is sooner)
- Change in Right-ventricular/Left-ventricular (RV/LV) Ratio, as Measured by Echocardiography or CT(Baseline to 24 hour visit)
- Modified Medical Research Council (mMRC) Dyspnea Score at 24 Hour Visit(At 24 hour visit)
- Modified Medical Research Council (mMRC) Dyspnea Score at 30 Day Visit(At 30 day visit)
- Length of Total Hospital Stay(Through 30 days post-procedure)
- Length of Post-index-procedure Hospital Stay(Through 30 days post-procedure)
- Pulmonary Embolism Quality of Life (PEmb-QOL) Score at 30 Day Visit(At 30 day visit)
- EQ-5D-5L Quality of Life Score at 30 Day Visit(At 30 day visit)
研究者
研究点 (116)
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