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

The Bashir™ Endovascular Catheter has been designed to administer therapeutic agents in the peripheral vasculature. Because of the unique design of the catheter, with its six expandable infusion limbs, the Bashir™ Endovascular Catheter has the ability to: 1. Create a much larger central channel for blood flow, thereby utilizing the body's own endogenous fibrinolytic agents to lyse the clot, and 2. Greatly enhance the radial dispersion of a catheter-administered thrombolytic agent throughout the thrombus. Expansion of the multiple arms of the basket in the infusion catheter causes fissuring of the clot. The net result is that a greater surface area of clot is exposed to both endogenous and exogenously administered lytic agents, thereby promoting clot dissolution.

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 < 30%;
• Platelets < 100,000/μL;
• INR > 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 < 90 mmHg for > 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 < one (1) year;
• Use of thrombolytics or glycoprotein IIb/IIIa antagonists within 3 days prior to inclusion in the study;
• Use of non-vitamin K oral anti-coagulants (NOACs), such as Rivaroxaban, Apixaban, Dabigatran, Edoxaban within 48 hours prior to inclusion in the study;
• Use of enoxaparin sodium injection (Lovenox®) within 12 hours of procedure start time;
• Profound bradycardia requiring a temporary pacemaker and/or inotropic support;
• Previous enrollment in this study;
• Morbidly obese (BMI >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.