KNOCOUT PE

September 18, 2018

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

  • Clinical Trial Information

    Trial Contact: Peisner, Pamela; Tinetti, Meghan

    Trial Phone: 321.843.1037 ; 321.841.3682

  • IRB No: 18.026.02

    Protocol Abbrev: KNOCOUT PE

    Principal Investigator: Mark A. Steiner, MD

    Phase: Device: Significant Risk

    Age Group: Adult

    Secondary Protocol No: BTG-001653-01

    Treatment: Device: EkoSonic® Endovascular System (EKOS)

    Therapies Involved: Procedural

    ClinicalTrials.gov ID: NCT03426124

  • Objective

    1. To understand the APT treatment protocol used as SoC
    across institutions and document changes in practice following the OPTALYSE PE results
    2. To describe the effects of varied APT protocols on long-term
    patient outcomes

  • Key Eligibility

    Retrospective
    1. Treated with APT Procedure since January 2014
    2. RV/LV > 1.0
    3. PE symptoms < 28 days
    4. Elevated Troponins

    Prospecitve
    1. 18-80 Years Old
    2. RV/LV > 1.0
    3. PE Symptoms < 14 days
    4. Troponin elevated
    5. EKOS device to treat patient with massive or submassive PE