Open Actively Recruiting

tPA by Endovascular Administration for the Treatment of Submassive PE Using CDT for the Reduction of Thrombus Burden


Brief 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.

Primary Purpose
Study Type
Phase 3


Healthy Volunteers
Minimum Age
18 Years
Maximum Age
75 Years

Inclusion Criteria:

  • Willing and able to provide informed consent;
  • Age 18 to ≤ 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 (CTA);
  • RV/LV 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:

  • CVA or TIA within one (1) year;
  • Head trauma, active intracranial, or intraspinal disease ≤ one (1) year prior to inclusion in the study;
  • Active bleeding from a major organ within one (1) month prior to inclusion in the study;
  • Intracranial condition(s) that may increase the risk of bleeding (e.g., neoplasms, arteriovenous malformations, or aneurysms);
  • Patients with bleeding diatheses;
  • Hematocrit < 30%;
  • Platelets < 100,000/μL;
  • INR > 1.5 if currently on warfarin (Coumadin®);
  • aPTT > 50 seconds in the absence of anticoagulants;
  • Major surgery ≤ 14 days prior to inclusion in the study;
  • Serum creatinine > 2.0mg/dL;
  • Clinician deems high-risk for catastrophic bleeding;
  • History of heparin-induced thrombocytopenia (HIT Syndrome);
  • Pregnancy;
  • SBP < 90 mmHg > 15 minutes within two (2) hours prior to BEC procedure and is not resolved with IV fluids;
  • Any vasopressor support;
  • Cardiac arrest (including pulseless electrical activity and asystole) requiring active cardiopulmonary resuscitation (CPR) during this hospitalization at treating institution and/or referring institution;
  • Evidence of irreversible neurological compromise;
  • Life expectancy < one (1) year;
  • Use of thrombolytics or glycoprotein IIb/IIIa inhibitor within 3 days prior to inclusion in the study;
  • 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;
  • Profound bradycardia requiring a temporary pacemaker and/or inotropic support;
  • Previous enrollment in this study;
  • Morbidly obese patient who by the judgement of the investigator is high risk for bleeding;
  • BMI > 45kg/m2;
  • Absolute contraindication to anticoagulation;
  • Uncontrolled hypertension defined as SBP > 175mmHg and / or DBP > 110mmHg with pharmacotherapy within two (2) hours prior to inclusion in the study;
  • Currently participating in another study;
  • Any arterial line placement;
  • 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;
  • In the opinion of the investigator, the subject is not a suitable candidate for the study.

Join this Trial

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Study Stats
Protocol No.
Radiological Sciences
Tammy Floore
  • UCLA Santa Monica
  • UCLA Westwood
For Providers
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