HI-PEITHO

Official Title

A randomized trial of ultrasound-facilitated, catheter-directed, thrombolysis versus anticoagulation for acute intermediate-high risk pulmonary embolism: The higher-risk pulmonary embolism thrombolysis study.

Study Purpose

To assess whether ultrasound-facilitated, catheter-directed, thrombolysis and anticoagulation are associated with a significant reduction in the composite outcome of pulmonary embolism (PE)-related mortality, cardiorespiratory decompensation or collapse, or nonfatal symptomatic and objectively confirmed recurrence of PE compared to anticoagulation alone within seven days of randomization.

Diagnosis

Eligibility

Patients must have elevated troponin levels and elevated risk.
Patients who are pregnant, on chronic anticoagulation, have metastatic cancer, stoke within 6 months or active bleeding are not eligible.

Intervention

EkoSonicTM Endovascular System and Anticoagulation