The RAPID - PE Study: RESCUE Advanced Protocol for the Treatment of Pulmonary Embolism

To demonstrate the efficacy and safety of the 8F BASHIR™ .035 Endovascular Catheter and the 8F BASHIR™ S-B .035 Endovascular Catheter for the administration of pharmaco-mechanical catheter directed therapy using pulse sprays of r-tPA into the pulmonary arteries for the treatment of intermediate risk pulmonary embolism (PE).

Inclusion Criteria 1. Willing and able to provide informed consent; 2. PE symptom duration ≤ 15 days; 3. Filling defect in at least one major lobar pulmonary artery as determined by CTA; 4. Patient is diagnosed with intermediate risk PE; 5. RV/LV diameter ratio ≥ 0.9 by CTA, as determined by investigative site; 6. Willing and able to comply with all study procedures and 7-day and 30-day telephone follow-up visit. Exclusion Criteria: 1. Previous history of stroke with residual hemiplegia; 2. Major surgery ≤ 10 days prior to inclusion in the study; 3. Platelet count \< 100,000/μL; 4. Pulmonary thrombectomy within the previous 4 days; 5. Uncontrolled hypertension defined as systolic blood pressure \>180 mm Hg and/or diastolic blood pressure \>110 mm Hg at the time of the procedure; 6. Administration of thrombolytic agents within the previous 4 days; 7. Absolute contraindication to anticoagulation; 8. Clinician deems high-risk for catastrophic bleeding; 9. Pregnancy; 10. Any vasopressor or inotropic support; 11. Cardiac arrest (including pulseless electrical activity (PEA) and asystole) requiring active cardiopulmonary resuscitation (CPR) during this hospitalization at treating institution and/or referring institution; 12. Planning to administer r-tPA by infusion after the r-tPA is administered by pulse sprays; 13. Currently participating in another study; 14. In the opinion of the investigator, the subject is not a suitable candidate for the study.