The Protrieve PROTECTOR Study

Exclusion Criteria

• •1. Current symptomatic PE
• •2. Known anatomic inability to place Protrieve device via jugular vein access site
• •3. Presence of clot extending to the IVC-Right Atrial junction or in the SVC
• •4. Subject is pregnant
• •5. Severe allergy to iodinated contrast agents that cannot be mitigated
• •6. INR \> 1.7 if not currently on anticoagulation therapy, platelets \< 50,000/μl which cannot be corrected prior to enrollment, or Hemoglobin \< 8.0 g/dL
• •7. Severe renal impairment in patients who are not yet on dialysis that in the Investigator's discretion would pose risk to the patient with the use of marketed contrast agents
• •8. Subject is participating in another study that may interfere with this study
• •9. Subject has any condition for which, in the opinion of the Investigator, participation would not be in the best interest of the subject
• •10. Subject has previously completed or withdrawn from this study
• •11. Limb-threatening circulatory compromise (e.g., phlegmasia)
• •12. Uncontrolled severe hypertension on repeated readings (systolic \> 180mmHg or diastolic \> 105mmHg)
• •13. Severe allergy, hypersensitivity to, or thrombocytopenia from heparin
• •14. Inability to provide therapeutic anticoagulation per Investigator discretion
• •15. Known hypercoagulable states that, in the opinion of the Investigator, cannot be medically managed throughout the study period
• •16. Inability to be a candidate for intervention due to medical or technical reasons based on physician judgement