First - In - Man Study to Assess the Safety and Feasibility of The Bashir™ Endovascular Catheter for the Treatment of Acute Pulmonary Embolism
Condition: Pulmonary Embolism
MeSH terms: Pulmonary Embolism; Embolism
Intervention: r-tPA; The Bashir™ Endovascular Catheter
Intervention description: Pulse spray and infusion; 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
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: 9.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Pulmonary Embolism

Summary:

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

Eligibility 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. 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.