tpa by endovascular administration for the treatment of submassive pe using cdt for the reduction of thrombus burden

Conditions: Pulmonary Embolism

Summary: to demonstrate the efficacy and safety of the bashir™ endovascular catheter for the administration of pharmaco-mechanical catheter directed therapy using low dose r-tpa for the treatment of acute submassive 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. this study will utilize the bashir™ endovascular catheter and the bashir endovascular catheter with a short basket (bashir™ s-b endovascular catheter) to administer catheter directed thrombolysis in patients with submassive pe who have consented and meet all eligibility criteria. the bashir™ and bashir™ s-b endovascular catheters represent a new methodology for localized catheter-based delivery of thrombolytics. the thrombolytic to be used in this study is r-tpa (genentech corporation, south san francisco, usa). the design of the bashir endovascular catheter with the multiple infusion limbs creating a basket-like formation when expanded, provides an immediate channel for blood flow through the thrombus and a greater surface area in the thrombus for the endogenous and exogenous thrombolytics to take effect, as described above.

Eligibility criteria:
inclusion criteria: 1. willing and able to provide informed consent; 2. age 18 to ≤ 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 (cta); 5. rv/lv 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. cva or tia within one (1) year; 2. head trauma, active intracranial, or intraspinal disease ≤ one (1) year prior to inclusion in the study; 3. active bleeding from a major organ within one (1) month prior to inclusion in the study; 4. intracranial condition(s) that may increase the risk of bleeding (e.g., neoplasms, arteriovenous malformations, or aneurysms); 5. patients with bleeding diatheses; 6. hematocrit \< 30%; 7. platelets \< 100,000/μl; 8. inr \> 1.5 if currently on warfarin (coumadin®); 9. aptt \> 50 seconds in the absence of anticoagulants; 10. major surgery ≤ 14 days prior to inclusion in the study; 11. serum creatinine \> 2.0mg/dl; 12. clinician deems high-risk for catastrophic bleeding; 13. history of heparin-induced thrombocytopenia (hit syndrome); 14. pregnancy; 15. sbp \ 15 minutes within two (2) hours prior to bec procedure and is not resolved with iv fluids; 16. any vasopressor support; 17. cardiac arrest (including pulseless electrical activity and asystole) requiring active cardiopulmonary resuscitation (cpr) during this hospitalization at treating institution and/or referring institution; 18. evidence of irreversible neurological compromise; 19. life expectancy \< one (1) year; 20. use of thrombolytics or glycoprotein iib/iiia inhibitor within 3 days prior to inclusion in the study; 21. use of non-vitamin k oral anti-coagulants (noacs), such as rivaroxaban (xarelto®), apixaban (eliquis®), dabigatran (pradaxa®), edoxaban (savaysa®) within 48 hours prior to inclusion in the study; 22. profound bradycardia requiring a temporary pacemaker and/or inotropic support; 23. previous enrollment in this study; 24. morbidly obese patient who by the judgement of the investigator is high risk for bleeding; 25. bmi \> 45kg/m2; 26. absolute contraindication to anticoagulation; 27. uncontrolled hypertension defined as sbp \> 175mmhg and / or dbp \> 110mmhg with pharmacotherapy within two (2) hours prior to inclusion in the study; 28. currently participating in another study; 29. any arterial line placement; 30. current positive covid diagnosis, or ≤ 8 weeks negative of covid, or \> 8 weeks from positive covid test and with current symptoms, or current active viral pneumonia on chest ct scan; 31. in the opinion of the investigator, the subject is not a suitable candidate for the study.

Keywords: pulmonary embolism catheter directed therapy