EkoSonic™ Endovascular System

Higher-risk Pulmonary Embolism Thrombolysis Study

Hear from the Principal Investigators

HI-PEITHO is a multi-center, prospective, randomized, controlled trial in the U.S. and Europe that will compare the outcomes of ultrasound-facilitated, catheter-directed, low-dose thrombolysis plus anticoagulation vs. anticoagulation alone for the treatment of acute, intermediate-high-risk pulmonary embolisms (PE).

Key Resources

Objective

Evaluate if treatment with the EkoSonic™ Endovasular System is associated with a significant reduction in the acute composite safety outcome of:

  • PE-Related Death
  • Cardiorespiratory decompensation or collapse, and
  • Non-fatal symptomatic and objectively confirmed recurrence of PE 

Compared to standard anticoagulation alone

Trial Design

  • Prospective, randomized, controlled
  • 1:1 randomization
  • Blinded endpoint adjudication
  • Treatment Arms:
    • EkoSonic® Endovascular System and Standard Anticoagulation
    • Standard Anticoagulation (control)
      • unfractionated heparin or low molecular weight heparin
  • Follow up at 7, 30, 90, and 365 days post-randomization

Acknowledgments

HI-PEITHO is a joint research study led by Boston Scientific, in partnership with the PERT Consortium and the University Medical Center of Mainz in collaboration with PEITHO International Study Network. 
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