The PERSEVERE Study

Eligibility Criteria

• 1. Age at enrollment ≥18 years
• 2. Objective evidence of a proximal filling defect in at least one main or lobar pulmonary artery
• 3. High-risk class of acute PE
• 4. RV dysfunction, as defined RV/LV ratio ≥1.0
• 5. Ability to begin randomized Index Treatment within 4 hours
• 6. 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
• 1. Prolonged cardiac arrest with loss of consciousness and/or neurological deficit.
• 2. Imaging evidence or other evidence that suggests, in the opinion of the Investigator, the patient is not appropriate for catheter-based intervention
• 3. Known pre-existing CTEPH, or CT signs of chronic PE that may point to pre-existing CTEPH
• 4. Recent stroke (\<14 days)
• 5. Recent cranial or spinal surgery (\<14 days)
• 6. Life-threatening active bleeding or hemorrhage into a critical area
• 7. Known intracranial tumor
• 8. End-stage medical condition with life expectancy \<3 months (irrespective of the severity of acute PE), as determined by the Investigator
• 9. Known sensitivity to radiographic contrast agents that, in the Investigator's opinion, cannot be adequately pre-treated
• 10. Inability to anticoagulate the patient, or known to have heparin-induced thrombocytopenia (HIT)
• 11. Current participation in another drug or device study that may interfere with the conduct of this trial
• 12. Ventricular arrhythmias refractory to treatment at the time of enrollment
• 13. 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
• 14. Subject is part of a vulnerable population (e.g., currently pregnant, breastfeeding or incarcerated) per local definitions
• 15. Subject has previously completed or withdrawn from this study
• 16. Subject has received prior thrombolytic (systemic or catheter-directed) or thrombectomy (surgical or catheter-based) therapy for index PE, within 30 days prior to randomization