tPA by Endovascular Administration for the Treatment of Submassive PE Using CDT for the Reduction of Thrombus Burden
Condition: Pulmonary Embolism
MeSH terms: Pulmonary Embolism; Embolism
Intervention: The Bashir™ Endovascular Catheter; r-tPA
Intervention description: The Bashir™ Endovascular Catheter is a device intended for the localized infusion of therapeutic agents into the pulmonary artery and peripheral vasculature.; Pulse spray and infusion
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Pulse Spray and Infusion of r-tPA
Masking: None (Open Label)
Enrollment: 109.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Pulmonary Embolism; Catheter Directed Therapy

Summary:

      To demonstrate the efficacy and safety of the Bashir™ Endovascular Catheter for the
      administration of pharmaco-mechanical catheter directed therapy using low dose r-tPA for the
      treatment of acute submassive pulmonary embolism.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Willing and able to provide informed consent;

          2. Age 18 to ≤ 75 years of age;

          3. PE symptom duration ≤ 14 days.

          4. Filling defect in at least one main or lobar pulmonary artery as determined by
             contrast enhanced chest CT (CTA);

          5. RV/LV diameter ratio ≥ 0.9 by CTA as determined by the investigative site;

          6. Willing and able to comply with all study procedures and follow-up.

        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.