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ULTRAsound-assisted Catheter-guided Thrombolysis for Intermediate-high Risk Patients With PE
Sponsor: National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
Summary
Pulmonary embolism (PE) is a life-threatening condition and a leading cause of cardiovascular mortality. While systemic thrombolysis is the standard treatment for high-risk PE, its bleeding risk limits use in some patients, highlighting the need for alternative reperfusion strategies such as catheter-directed thrombolysis (CDT). This prospective study will evaluate the safety and efficacy of CDT using the EkoSonic Endovascular System (EKOS; Boston Scientific) in patients with intermediate-high and high-risk PE. The primary outcome is all-cause mortality through 360 days of follow-up, with secondary outcomes including changes in echocardiographic parameters such as the RV/LV diameter ratio.
Official title: ULTRAsound-assisted Catheter-guided Thrombolysis for Intermediate-high Risk Patients With Pulmonary Embolism
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
300
Start Date
2024-09-10
Completion Date
2030-09-10
Last Updated
2026-03-17
Healthy Volunteers
No
Conditions
Interventions
Ultrasound-assisted Catheter-guided Thrombolysis
The goal of the ULTRA-PE trial is to investigate the safety and clinical efficacy of ultrasound-assisted catheter-guided thrombolysis in intermediate-high risk patients with pulmonary embolism (PE) in Russia.
Locations (1)
National Medical Research Center for Cardiology named after academician Yevgeniy Chazov of the Ministry of Health of the Russian Federation
Moscow, Russia