The EKOS™ Endovascular System is the most studied device in the pulmonary embolism space


EKOS Endovascular System PE Clinical Studies

The HI-PEITHO study has been designed to address a critical gap in clinical evidence in Pulmonary Embolism by comparing the clinical benefit of intervention with EKOS vs. the current standard of care – anticoagulation.

It is designed to generate the most rigorous, highest level of data, contributing to the body of evidence for the treatment and outcomes in acute intermediate-high risk PE.

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Download the Boston Scientific study summary

Trial overview

  • Large-scale, transatlantic, multi-center, prospective, randomized, controlled trial
  • 406-544 patients with acute intermediate-high risk PE
  • Up to 65 centers in U.S.A and Europe
  • Primary outcome: composite of PE-related death, cardiorespiratory decompensation or collapse, and non-fatal symptomatic and objectively confirmed recurrence of PE
  • 18 additional secondary endpoints to be assessed


  • Estimated enrollment: 406-544 participants​
  • Acute intermediate high-risk pulmonary embolism
  • ​RV/LV > 1.0, elevated troponin, & risk of early death/hemodynamic collapse​

Trial design


Trial end points & assessments

End Points

7-day composite of –

  • PE-related mortality
  • PE recurrence (non-fatal symptomatic and objectively confirmed)
  • Cardiorespiratory decompensation or collapse

Cardiorespiratory decompensation or collapse, defined as at least one of the following:

  • Cardiac arrest or need for CPR​
  • Signs of shock: new onset arterial hypotension with end-organ hypoperfusion​
  • ECMO placement
  • ​Intubation or noninvasive mechanical ventilation​
  • National Early Warning Score (NEWS) of 9 or higher

Long term follow-up
Additional follow-ups at 30-days, 6 months, and 1-year 

National early warning score (NEWS)

The NEWS is an early warning system score for clinical deterioration in hospitalised patients – it standardises the assessment of acute-illness severity.

The score aims to objectify how the patient is doing at the bedside.

The NEWS is based on an aggregate scoring system based on physiological measurements – respiration rate, oxygen saturations, supplemental oxygen need, temperature, systolic blood pressure, heart rate, and level of consciousness.

Reproduced from: Royal College of Physicians. National Early Warning Score (NEWS): Standardising the assessment of acute-illness severity in the NHS. Report of a working party. London: RCP, 2012

  • Individual primary outcome components
  • GUSTO major (moderate and severe) bleeding within 7 days
  • International Society on Thrombosis and Haemostasis (ISTH) major bleeding
  • Ischemic or hemorrhagic stroke within 7 days and 30 days
  • All-cause mortality
  • Symptomatic PE recurrence within 30 days and 6 months
  • Change from baseline in RV dysfunction on echocardiography at 6 months
  • Chronic thromboembolic pulmonary hypertension (CTEPH) diagnosis within 12 months
  • Health economic assessments
  • Functional status and quality of life measures
  • Cardiopulmonary Exercise Testing (CPET) at select sites

Trial bibliography

Underway – HI-PEITHO: The HI-PEITHO study has been designed to address a critical gap in clinical evidence in PE by comparing the clinical benefit of intervention with EKOS vs. the current standard of care – anticoagulation. 

Principal Investigators: Ken Rosenfeld, M.D., Section Head, Vascular Medecine and Intervention, Division of Cardiology, Mass General Hospital, Boston, Massachussets ; Stavros Konstantinidis, M.D. Ph.D. FESC, FRCP (Glasgow), Professor, Clinical Trials, and Medical Director (CTH), Johannes Gutenberg University, Mainz.

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