first - in - man study to assess the safety and feasibility of the bashir™ endovascular catheter for the treatment of acute pulmonary embolism

Conditions: 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.

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.

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 \ 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.

Keywords: pulmonary embolism