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

About

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
Treatment
Study Type
Interventional
Phase
Phase 3

Eligibility

Gender
All
Healthy Volunteers
No
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.

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Study Stats
Protocol No.
20-000635
Category
Radiological Sciences
Contact
Tammy Floore
Location
  • UCLA Santa Monica
  • UCLA Westwood
For Providers
NCT No.
NCT04248868
For detailed technical eligibility, visit ClinicalTrials.gov.