Actively Recruiting
ULTRAsound-assisted Catheter-guided Thrombolysis for Intermediate-high Risk Patients With PE
Led by National Medical Research Center for Cardiology, Ministry of Health of Russian Federation · Updated on 2026-03-17
300
Participants Needed
1
Research Sites
313 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
ULTRAsound-assisted Catheter-guided Thrombolysis for Intermediate-high Risk Patients With PE
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years at the time of enrollment
- Able to provide written informed consent or have a legally authorized representative provide consent
- Confirmed acute pulmonary embolism by CT pulmonary angiography showing clot in pulmonary arteries
- Hemodynamically stable at presentation, not meeting high-risk criteria such as sustained low blood pressure or shock
- Evidence of right ventricular dysfunction on imaging with RV/LV ratio greater than 1.0
- Elevated cardiac biomarkers like troponin I or T above normal
- Intermediate-high risk defined by the combination of right heart dysfunction and positive cardiac biomarkers
- At least one clinical sign of early risk: tachycardia (heart rate 100 bpm), mild low systolic blood pressure ( 110 mmHg but not high-risk), or low oxygen levels (SpO2 < 90% on room air)
You will not qualify if you...
- Hemodynamic instability defined by any of the following: systolic blood pressure < 90 mmHg or drop 40 mmHg for over 15 minutes not caused by arrhythmia, hypovolemia, or sepsis
- Need for vasopressors to maintain systolic blood pressure 90 mmHg
- Cardiogenic shock with signs of organ poor blood flow such as altered mental status or low urine output
- Need for ECMO or mechanical circulatory support before assessment
- Cardiac arrest requiring resuscitation
- Active major bleeding or high bleeding risk conditions like intracranial pathology
- Recent (less than 3 months) brain or spinal surgery, major trauma, or stroke
- Known central nervous system tumor or metastatic cancer with high bleeding risk
- Previous use of systemic thrombolytics or catheter-directed thrombolysis for the current PE episode
- Known allergy to alteplase, unfractionated heparin, or their components
- Need for intensive care due to conditions unrelated to the current PE
- Symptoms from the current PE lasting more than 14 days
- Severe low platelet count (below 100 x 10^9/L) or blood clotting problems preventing safe catheter use
- Life expectancy less than 6 months due to other advanced diseases
- Pregnancy
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
National Medical Research Center for Cardiology named after academician Yevgeniy Chazov of the Ministry of Health of the Russian Federation
Moscow, Russia
Actively Recruiting
Research Team
O
Oleg Dorogun, MD
CONTACT
N
Nikita Grishin, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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