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

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. Use of enoxaparin sodium injection (Lovenox®) within 12 hours of procedure start time;
• •23. Profound bradycardia requiring a temporary pacemaker and/or inotropic support;
• •24. Previous enrollment in this study;
• •25. Morbidly obese (BMI \>45 kg/m2) patient who by the judgement of the investigator is high risk for bleeding;
• •26. Absolute contraindication to anticoagulation;
• •27. Uncontrolled hypertension;
• •28. Currently participating in another study;
• •29. In the opinion of the investigator, the subject is not a suitable candidate for the study.