PEERLESS II: RCT of FlowTriever vs. Anticoagulation Alone in Pulmonary Embolism
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,200
- 试验地点
- 170
- 主要终点
- Composite clinical endpoint constructed as a win ratio, a hierarchy of the following, which are assessed post-randomization:
研究概览
简要总结
This study is a prospective, multicenter, randomized controlled trial of the FlowTriever System plus anticoagulation compared to anticoagulation alone for intermediate-risk acute PE.
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, as confirmed by CTPA, pulmonary angiography, or other imaging modality
- •RV dysfunction, as defined as one or more of the following: RV/LV ratio ≥ 0.9 or RV dilation or hypokinesis
- •At least two additional risk factors, identified by at least one measure in two separate categories noted below:
- •a. Hemodynamic: i. SBP 90-100mmHg ii. Resting heart rate > 100 bpm b. Biomarker: i. Elevated* cardiac troponin (troponin I or troponin T, conventional or high sensitivity) ii. Elevated* BNP or NT-proBNP iii. Elevated venous lactate ≥2 mmol/L * Elevated, meaning at or above the upper limit of normal, per local standards for the assay used c. Respiratory: i. O2 saturation < 90% on room air ii. Supplemental O2 requirement ≥ 4 L/min iii. Respiratory rate ≥ 20 breaths/min iv. mMRC score > 0
- •Symptom onset within 14 days of confirmed PE diagnosis
- •Willing and able to provide informed consent
排除标准
- •Unable to be anticoagulated with heparin, enoxaparin or other parenteral antithrombin
- •Presentation with hemodynamic instability* that meets the high-risk PE definition in the 2019 ESC Guidelines1, 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 * Patients who are stable at time of screening or randomization (i.e., SBP ≥ 90 mmHg and adequate organ perfusion without catecholamine or vasopressor infusion) may be included despite initial presentation including temporary, low-dose catecholamines or vasopressors, or temporary fluid resuscitation.
- •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)
- •End stage medical condition with life expectancy < 3 months, 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 2019 ESC Guidelines1
- •If objective testing was performed*, estimated RV systolic pressure > 70 mmHg on standard of care echocardiography * If clinical suspicion of acute-on-chronic PE, chronic obstruction, or chronic thromboembolism, echocardiographic estimated RVSP must be confirmed ≤70 mmHg to meet eligibility. Pressure assessment not required if Investigator attests to absence of such clinical suspicion
- •Administration of advanced therapies (thrombolytic bolus, thrombolytic drip/infusion, catheter-directed thrombolytic therapy, mechanical thrombectomy, or ECMO) for the index PE event within 30 days 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 System per local approved labeling
- •Subject is currently pregnant
- •Subject has previously completed or withdrawn from this study
研究组 & 干预措施
FlowTriever
Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.
干预措施: FlowTriever System (Device)
Anticoagulation
Commercially available/market approved anticoagulation medication including but not limited to: Heparin Sodium, Coumadin, Rivaroxaban, Apixaban, etc.
Anticoagulants are a group of medications that decrease your blood's ability to clot.
干预措施: Anticoagulation Agents (Drug)
结局指标
主要结局
Composite clinical endpoint constructed as a win ratio, a hierarchy of the following, which are assessed post-randomization:
时间窗: through discharge or 30 days, whichever is sooner / dyspnea at 48 hours
* All-cause mortality by 30 days, or * Clinical deterioration, defined by hemodynamic or respiratory worsening, through discharge or up to 30 days after randomization, whichever is sooner, or * All-cause hospital re-admission by 30 days, or * Bailout therapy, either after a deterioration or after documented failure to progress, through discharge or up to 30 days after randomization, whichever is sooner, or * Change in Dyspnea, by mMRC from Baseline to the 48-hour visit
Composite clinical endpoint constructed as a win ratio, a hierarchy of the following, which are assessed post-randomization:
时间窗: through discharge or 30 days, whichever is sooner / dyspnea at 48 hours
* All-cause mortality by 30 days, or * Clinical deterioration, defined by hemodynamic or respiratory worsening, through discharge or up to 30 days after randomization, whichever is sooner, or * All-cause hospital re-admission by 30 days, or * Bailout therapy, either after a deterioration or after documented failure to progress, through discharge or up to 30 days after randomization, whichever is sooner, or * Change in Dyspnea, by mMRC from Baseline to the 48-hour visit
次要结局
- Composite clinical endpoint constructed as a win ratio hierarchy of the following three components, assessed post randomization:(up to 30 days)
- All-cause and PE-related mortality(At 30 and 90 days)
- PE-related quality of life, by PEmb-QoL(At the 1- and 3-month visits)
- All-cause and PE-related readmissions(At 30 and 90 days)
- Major Bleeding, defined by the Bleeding Academic Research Consortium (BARC), level 3b, 3c, 5a, or 5b(At 30 and 90 days)
- Dyspnea severity by mMRC score(At the 48-hour, 1-month, and 3-month visits)
- RV/LV ratio(At the 48-hour visit)
- Clinical deterioration(Through discharge or up to 30 days after randomization, whichever is sooner)
- Bailout therapy(Through discharge or up to 30 days after randomization, whichever is sooner)
- General health-related quality of life, by EQ-5D-5L(At the 1- and 3-month visits)
- 6-minute walk distance(At the 1-month visit)
- Post-PE Impairment diagnosis (PPEI)(Through the 3-month visit)