RecruitingNot ApplicableNCT06055920
The PEERLESS II Study
PEERLESS II: RCT of FlowTriever vs. Anticoagulation Alone in Pulmonary Embolism
Sponsor
Inari Medical
Enrollment
1,200 participants
Start Date
Nov 17, 2023
Study Type
INTERVENTIONAL
Conditions
Summary
This study is a prospective, multicenter, randomized controlled trial of the FlowTriever System plus anticoagulation compared to anticoagulation alone for intermediate-risk acute PE.
Eligibility
Min Age: 18 Years
Inclusion Criteria7
- 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
Exclusion Criteria17
- 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
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Interventions
DEVICEFlowTriever System
Mechanical Thrombectomy for pulmonary embolism
DRUGAnticoagulation Agents
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.
Locations(83)
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NCT06055920
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