Submassive and Massive Pulmonary Embolism Treatment With Ultrasound Accelerated Thrombolysis Therapy

A Prospective, Single-Arm, Multi-Center Trial of EkoSonic® Endovascular System and Activase for Treatment of Acute Pulmonary Embolism (PE)

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.

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