tPA by Endovascular Administration for the Treatment of Submassive PE Using CDT for the Reduction of Thrombus Burden

Exclusion Criteria

• •1. CVA or TIA within one (1) year;
• •2. Head trauma, active intracranial, or intraspinal disease ≤ one (1) year prior to inclusion in the study;
• •3. Active bleeding from a major organ within one (1) month prior to inclusion in the study;
• •4. Intracranial condition(s) that may increase the risk of bleeding (e.g., neoplasms, arteriovenous malformations, or aneurysms);
• •5. Patients with bleeding diatheses;
• •6. Hematocrit \< 30%;
• •7. Platelets \< 100,000/μL;
• •8. INR \> 1.5 if currently on warfarin (Coumadin®);
• •9. aPTT \> 50 seconds in the absence of anticoagulants;
• •10. Major surgery ≤ 14 days prior to inclusion in the study;
• •11. Serum creatinine \> 2.0mg/dL;
• •12. Clinician deems high-risk for catastrophic bleeding;
• •13. History of heparin-induced thrombocytopenia (HIT Syndrome);
• •14. Pregnancy;
• •15. SBP \< 90 mmHg \> 15 minutes within two (2) hours prior to BEC procedure and is not resolved with IV fluids;
• •16. Any vasopressor support;
• •17. Cardiac arrest (including pulseless electrical activity and asystole) requiring active cardiopulmonary resuscitation (CPR) during this hospitalization at treating institution and/or referring institution;
• •18. Evidence of irreversible neurological compromise;
• •19. Life expectancy \< one (1) year;
• •20. Use of thrombolytics or glycoprotein IIb/IIIa inhibitor within 3 days prior to inclusion in the study;
• •21. Use of non-vitamin K oral anti-coagulants (NOACs), such as rivaroxaban (Xarelto®), apixaban (Eliquis®), dabigatran (Pradaxa®), edoxaban (Savaysa®) within 48 hours prior to inclusion in the study;
• •22. Profound bradycardia requiring a temporary pacemaker and/or inotropic support;
• •23. Previous enrollment in this study;
• •24. Morbidly obese patient who by the judgement of the investigator is high risk for bleeding;
• •25. BMI \> 45kg/m2;
• •26. Absolute contraindication to anticoagulation;
• •27. Uncontrolled hypertension defined as SBP \> 175mmHg and / or DBP \> 110mmHg with pharmacotherapy within two (2) hours prior to inclusion in the study;
• •28. Currently participating in another study;
• •29. Any arterial line placement;
• •30. Current positive COVID diagnosis, or ≤ 8 weeks negative of COVID, or \> 8 weeks from positive COVID test and with current symptoms, or current active viral pneumonia on chest CT scan;
• •31. In the opinion of the investigator, the subject is not a suitable candidate for the study.