Research & Innovation

EKOS KNOCOUT BTG

Clinical Trials

EKOS KNOCOUT BTG

Retrospective and prospective international EKoSoNic® registry Of the treatment and Clinical OUTcomes of patients with Pulmonary Embolism (KNOCOUT PE)

Physician & Study Coordinator

Study Coordinator

Tom Parsons
484-526-7825

Thomas.Parsons@sluhn.org

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Synopsis

Synopsis: The purpose of this clinical Registry is to understand how doctors are currently treating lung artery clots with clot-dissolving drugs and EKOS. Data collected for the Registry will focus on length of treatment, amount of drug used and how your health and quality of life are impacted over time by the treatment.

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Inclusion Criteria
  • Retrospective Inclusion Criteria:
    • Treated with APT procedure between January 1, 2014 and one year prior to site activation
    • RV/LV ≥ 1.0 from diagnostic computed tomographic angiography (CTA) or echocardiogram
    • PE symptom duration ≤ 14 days
    • Troponin elevation 
  • Prospective Inclusion Criteria:
    • Male or female ≥ 18 years of age and ≤ 80 years of age
    • RV/LV ≥ 1.0 from diagnostic computed tomographic angiography (CTA) or echocardiogram
    • PE symptom duration ≤ 14 days
    • Troponin elevation
    • Signed informed consent obtained from subject or legally authorized representative
    • Investigator has selected the EKOS device to treat patient with massive or submassive pulmonary embolism

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Exclusion Criteria
  • Retrospective Exclusion Criteria:
    • Enrollment into the OPTALYSE PE study
  • Prospective Exclusion Criteria:
    • Clinician deems the subject high-risk for catastrophic bleeding
    • Life expectancy < one year

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