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

Inclusion Criteria

General Inclusion Criteria:

• Willing and able to provide informed consent;
• 18 years of age and less than 75 years of age;
• PE symptom duration ≤ 14 days;
• Filling defect in at least one main or lobar pulmonary artery as determined by contrast enhanced chest CT;
• RV/LV end diastolic diameter ratio ≥ 0.9 by CTA as determined by the investigative site;
• Willing and able to comply with all study procedures and follow-up.

Exclusion Criteria

• Cerebrovascular Accident (CVA) or transient ischemic attack (TIA) within one (1) year;
• Head trauma, or other active intracranial, or intraspinal disease within one (1) year;
• Recent (within one month) or active bleeding from a major organ;
• Intracranial condition(s) that may increase the risk of bleeding (e.g., neoplasms, arteriovenous malformations, or aneurysms);
• Patients with bleeding diathesis;
• Hematocrit 1.5;
• aPTT > 50 seconds in the absence of anticoagulants;
• Major surgery within fourteen (14) days;
• Serum creatinine > 2 mg/dL;
• Clinician deems high-risk for catastrophic bleeding;
• History of heparin-induced thrombocytopenia (HIT);
• Pregnancy;
• Systolic blood pressure 15 minutes;
• Any vasopressor support;
• Cardiac arrest (including pulseless electrical activity and asystole) requiring active cardiopulmonary resuscitation (CPR);
• Evidence of irreversible neurological compromise;
• Life expectancy 45 kg/m2) patient who by the judgement of the investigator is high risk for bleeding;
• Absolute contraindication to anticoagulation;
• Uncontrolled hypertension;
• Currently participating in another study;
• In the opinion of the investigator, the subject is not a suitable candidate for the study.