Condition: Pulmonary embolism
Key Inclusion Criteria:
- 18-80 years old
- Objectively confirmed acute pulmonary embolism
- Elevated risk of early death/hemodynamic collapse
Key Exclusion Criteria:
- Hemodynamic instability
- Need for admission to an intensive care unit for a reason other than the index pulmonary embolism episode
- Temperature above 39o C / 102.2o F
- Pregnancy or lactation
Full Study Name
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 (IRB no. 00001589)
This study focuses on individuals who have been diagnosed with pulmonary embolism (having a blood clot in one or both of the lungs). The purpose of the study is to investigate whether treatment with anticoagulation (blood thinner) medications in combination with the EkoSonic Endovascular device and a dose of a clot-dissolving drug can reduce the risk of death and other serious problems when compared to anticoagulation medication alone. The EkoSonic Endovascular System provides electrical energy and catheters to deliver clot-dissolving drug to the clot. Measurements will also be taken to observe overall health and quality of life for one year after treatment.
Participants will be randomly assigned to receive either anticoagulant medication alone, or treatment with anticoagulation medications in combination with the EkoSonic Endovascular device and clot-dissolving drug. The device, procedure and treatment with anticoagulation medication are not considered to be investigational.