Study of Ultrasound-Assisted Catheter-Guided Thrombolysis Using EKOS System in Adults With Intermediate-High Risk Pulmonary Embolism

What this Trial Is About

Pulmonary embolism PE is a serious and potentially fatal condition that ranks high among cardiovascular causes of death worldwide. Standard treatment for high-risk PE involves systemic thrombolysis, but this approach carries a significant bleeding risk and is not suitable for all patients. Researchers are evaluating catheter-directed thrombolysis CDT using the EkoSonic Endovascular System EKOS to assess its safety and effectiveness in patients with intermediate-high and high-risk PE, aiming to provide more controlled data on this treatment approach. In this study, 300 patients with intermediate-high risk PE who have no contraindications will receive ultrasound-assisted catheter-guided thrombolysis using the EKOS device. The treatment involves delivering a thrombolytic drug directly at the clot site with the help of ultrasound. The dosing and treatment regimen will be personalized based on decisions by the institutional heart team. This approach offers advantages like shorter infusion times and lower drug doses compared to systemic thrombolysis. Participants will be monitored through follow-up visits up to 360 days after treatment. The main measure of success is all-cause mortality assessed at multiple time points, including 48 hours, 7 days or discharge, and one year. Secondary outcomes include changes in heart and lung function measured by echocardiographic parameters such as the ratio of right to left ventricular size. Safety events like bleeding, stroke, and kidney injury will also be tracked throughout the study period.

ULTRAsound-assisted Catheter-guided Thrombolysis for Intermediate-high Risk Patients With PE