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.
Adults aged ≥ 18 years at time of enrollment;
Ability to provide written informed consent (or legally authorized representative consent where applicable);
Objectively confirmed acute pulmonary embolism (PE) by contrast-enhanced computed tomography pulmonary angiography (CTPA) demonstrating intraluminal filling defects in at least one segmental, lobar, or more proximal pulmonary artery;
Hemodynamically stable at presentation (i.e., not meeting high-risk PE criteria of sustained hypotension, shock, or need for vasopressor support per ESC 2019 and AHA/ACC risk stratification);
Systolic blood pressure (SBP) < 90 mmHg or a drop ≥ 40 mmHg from baseline for > 15 minutes not attributable to arrhythmia, hypovolemia, or sepsis,
Requirement for vasopressors to maintain SBP ≥ 90 mmHg,
Cardiogenic shock, defined by clinical signs of end-organ hypoperfusion (e.g., altered mental status, oliguria, lactate elevation),
Need for ECMO or other mechanical circulatory support initiated prior to assessment,
Single group
Ultrasound-assisted Catheter-guided Thrombolysis
DeviceThe 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.
All-cause mortality
Total number of deaths from any cause.
Net Adverse Clinical Events (NACE)
Composite endpoint reflecting net clinical benefit, including: all-cause mortality; hemodynamic decompensation (vasopressor initiation, mechanical ventilation, cardiac arrest, escalation to systemic thrombolysis or surgical embolectomy); major bleeding (BARC 3-5 or ISTH major bleeding); intracranial hemorrhage
Pulmonary Embolism Severity Index (PESI) Score
Assessment of clinical risk stratification using the validated PESI score (Pulmonary Embolism Severity Index, values from 0 till 130+, the lower the better). Both absolute score and change from baseline will be analyzed, including transition between risk classes.
Right Ventricular to Left Ventricular (RV/LV) Ratio
Ratio measured by transthoracic echocardiography or computed tomography pulmonary angiography. Evaluates right ventricular pressure overload and recovery.
Systolic Pulmonary Artery Pressure (sPAP)
Measured by transthoracic echocardiography, estimated from tricuspid regurgitation velocity. Reflects pulmonary hypertension severity.
Basal Right Ventricular Diameter (cm)
Measured by transthoracic echocardiography
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