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

• Status: Recruiting
• Trial end date: 2022-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Thrombolex, Inc.
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)

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.