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
