Clinical Research Trials

Key Trial Criteria

• Key Inclusion Criteria

  For a patient to be eligible for participation in this study, all of the following criteria must apply.

  • Age ≥ 18 years
  • Echo, computed tomographic pulmonary angiography (CTPA), or pulmonary angiographic evidence of any proximal filling defect in at least one main or lobar pulmonary artery
  • Classification of intermediate-high-risk PE by ESC Guidelines 2019, including ALL of the following: clinical signs and symptoms consistent with acute PE, or PESI class III-V, or sPESI ≥1; AND hemodynamically stable; AND RV dysfunction on echocardiography or CT; AND elevated cardiac troponin levels
  • Intervention planned to begin within 72 hours of the later of either: confirmed PE diagnosis; OR if transferring from another hospital, arrival at the treating hospital
  • Symptom onset within 14 days of confirmed PE diagnosis

• Key Exclusion Criteria

  A patient will not be eligible for participation in this study if any of the following criteria apply.

  • 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)
  • Subject has previously completed or withdrawn from this study
  • Patient unwilling or unable to conduct the follow up visits per protocol.