Submassive and Massive Pulmonary Embolism Treatment With Ultrasound Accelerated Thrombolysis Therapy
The purpose of this study is to determine if the EKOS EkoSonic® Endovascular Device when used in conjunction with recombinant t-PA as a treatment for acute pulmonary embolism (PE) will decrease the ratio of RV to LV diameter within 48 ± 6 hours in patients with massive or submassive PE.
Stanford is now accepting new patients for this trial.
- device : EKOS EkoSonic Endovascular System
- drug : Alteplase
- drug : recombinant tissue plasminogen activator
Phase: Phase 3
Ages Eligible For Study:
- CT evidence of proximal PE (filling defect in at least one main or segmental pulmonary artery) AND - Age ? 18 years AND - PE symptom duration ?14 days AND - Informed consent can be obtained from subject or Legally Authorized Representative (LAR) AND - Massive PE (syncope, systemic arterial hypotension, cardiogenic shock, or resuscitated cardiac arrest) OR - Submassive PE (RV diameter-to-LV diameter ? 0.9 on contrast-enhanced chest CT)