First - In - Man Study to Assess the Safety and Feasibility of The Bashir™ Endovascular Catheter for the Treatment of Acute Pulmonary Embolism

• Status: Active, not recruiting
• Trial end date: 2020-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The Bashir™ Endovascular Catheter is a device intended for the localized infusion of therapeutic agents into the pulmonary artery and peripheral vasculature.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Thrombolex, Inc.

Criteria

Inclusion Criteria:

General Inclusion Criteria:

1. Willing and able to provide informed consent;

2. 18 years of age and less than 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;

5. RV/LV end diastolic 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. Cerebrovascular Accident (CVA) or transient ischemic attack (TIA) within one (1) year;

2. Head trauma, or other active intracranial, or intraspinal disease within one (1) year;

3. Recent (within one month) or active bleeding from a major organ;

4. Intracranial condition(s) that may increase the risk of bleeding (e.g., neoplasms, arteriovenous malformations, or aneurysms);

5. Patients with bleeding diathesis;

6. Hematocrit < 30%;

7. Platelets < 100,000/μL;

8. INR > 1.5;

9. aPTT > 50 seconds in the absence of anticoagulants;

10. Major surgery within fourteen (14) days;

11. Serum creatinine > 2 mg/dL;

12. Clinician deems high-risk for catastrophic bleeding;

13. History of heparin-induced thrombocytopenia (HIT);

14. Pregnancy;

15. Systolic blood pressure < 90 mmHg for > 15 minutes;

16. Any vasopressor support;

17. Cardiac arrest (including pulseless electrical activity and asystole) requiring active cardiopulmonary resuscitation (CPR);

18. Evidence of irreversible neurological compromise;

19. Life expectancy < one (1) year;

20. Use of thrombolytics or glycoprotein IIb/IIIa antagonists within 3 days prior to inclusion in the study;

21. Use of non-vitamin K oral anti-coagulants (NOACs), such as Rivaroxaban, Apixaban, Dabigatran, Edoxaban 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. Absolute contraindication to anticoagulation;

26. Uncontrolled hypertension;

27. Currently participating in another study;

28. In the opinion of the investigator, the subject is not a suitable candidate for the study.