The PEERLESS Study

Exclusion Criteria

• •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• •Subject has previously completed or withdrawn from this study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.