The Protrieve PROTECTOR Study

Eligibility Criteria

• 1. Age ≥ 18 years
• 2. Planned intervention for DVT presenting with one or more of the following characteristics indicative of elevated risk for PE:
• 1. Bilateral iliofemoral DVT
• 2. Clot extending into or located in the IVC
• 3. In-stent thrombosis
• 4. Presence of thrombosed IVC filter
• 5. Other features that the investigator deems put the subject at elevated risk for thromboembolism
• 3. Willing and able to provide informed consent
• 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 Subject has previously completed or withdrawn from this study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