Submassive and Massive Pulmonary Embolism Treatment With Ultrasound Accelerated Thrombolysis Therapy
Condition: Pulmonary Embolism; Acute Pulmonary Embolism; Sub-massive Pulmonary Embolism; Massive Pulmonary Embolism; Pulmonary Thromboembolism
MeSH terms: Pulmonary Embolism; Embolism; Thromboembolism
Intervention: recombinant tissue plasminogen activator; EKOS EkoSonic Endovascular System
Intervention description: Participants will receive 24 mg of r-tPA delivered via the EkoSonic Endovascular Device.; 24 mg of r-tPA will be delivered through the EkoSonic Endovascular System.
Intervention MeSH terms: Tissue Plasminogen Activator; Plasminogen
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 150.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Fibrinolysis; catheter directed fibrinolysis; ultrasound accelerated fibrinolysis; recombinant t-PA; Activase

Summary:

      The purpose of this study is to determine if the EKOS EkoSonic® Endovascular Device when used
      in conjunction with recombinant tissue plasminogen activator (t-PA) as a treatment for acute
      PE will decrease the ratio of right ventricle (RV) to left ventricle (LV) diameter within 48
      =/- 6 hours in participants with massive or submassive PE.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Computed tomography (CT) evidence of proximal PE (filling defect in at least one main
             or segmental pulmonary artery)

          -  PE symptom duration less than or equal to (<=)14 days

          -  Informed consent can be obtained from participant or Legally Authorized Representative
             (LAR)

          -  Massive PE (syncope, systemic arterial hypotension, cardiogenic shock, or resuscitated
             cardiac arrest) or

          -  Submassive PE (RV diameter-to-LV diameter greater than or equal to [>=] 0.9 on
             contrast-enhanced chest CT)

        Exclusion Criteria:

          -  Stroke or transient ischemic attack (TIA), head trauma, or other active intracranial
             or intraspinal disease within one year

          -  Recent (within one month) or active bleeding from a major organ

          -  Hematocrit less than (<) 30 percent (%)

          -  Platelets < 100 thousand/microliter (mcL)

          -  International Normalized Ratio (INR) greater than (>) 3

          -  Activated partial thromboplastin time (aPTT) >50 seconds on no anticoagulants

          -  Major surgery within seven days of screening for study enrollment

          -  Serum creatinine >2 milligrams/deciliter (mg/dL)

          -  Clinician deems high-risk for catastrophic bleeding

          -  History of heparin-induced thrombocytopenia (HIT)

          -  Pregnancy

          -  Catheter-based pharmacomechanical treatment for pulmonary embolism within 3 days of
             study enrollment

          -  Systolic blood pressure less than 80 mm Hg despite vasopressor or inotropic support

          -  Cardiac arrest (including pulseless electrical activity and asystole) requiring active
             cardiopulmonary resuscitation (CPR)

          -  Evidence of irreversible neurological compromise

          -  Life expectancy <30 days

          -  Use of thrombolytics or glycoprotein IIb/IIIa antagonists within 3 days prior to
             inclusion in the study

          -  Previous enrollment in the SEATTLE study