The PERSEVERE Study

Inclusion criteria

• 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

Exclusion criteria

• 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