New ultrasound-guided treatment could save lives from deadly lung clots
NCT ID NCT07452991
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a treatment that uses a thin tube and ultrasound waves to break up dangerous blood clots in the lungs. It is for people with moderate-to-high risk pulmonary embolism who cannot safely receive standard clot-busting drugs due to bleeding risks. The study will track 300 adults over one year to see if this approach reduces deaths and complications.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 300 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2024
- Expected to finish
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Sep 2030
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a government body.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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); * Evidence of right ventricular (RV) dysfunction on imaging (e.g., RV/LV ratio \> 1.0 on CTPA or echocardiography); * Elevated cardiac biomarkers, including troponin I or T above the upper limit of normal; * Intermediate-high risk features defined as the combination of imaging RV dysfunction and positive cardiac biomarkers, consistent with ESC stratification; * At least one clinical indicator of elevated early risk such as: 1. Tachycardia (e.g., HR ≥ 100 bpm), 2. Mild systolic blood pressure reduction (e.g., SBP ≤ 110 mmHg but not meeting high-risk thresholds), 3. Hypoxemia (SpO₂ \< 90% on room air). Exclusion Criteria: * Presence of hemodynamic instability, defined as at least one of the following: 1. Systolic blood pressure (SBP) \< 90 mmHg or a drop ≥ 40 mmHg from baseline for \> 15 minutes not attributable to arrhythmia, hypovolemia, or sepsis, 2. Requirement for vasopressors to maintain SBP ≥ 90 mmHg, 3. Cardiogenic shock, defined by clinical signs of end-organ hypoperfusion (e.g., altered mental status, oliguria, lactate elevation), 4. Need for ECMO or other mechanical circulatory support initiated prior to assessment, 5. Cardiac arrest requiring resuscitation. * Active major bleeding or conditions with high bleeding risk (e.g., known intracranial pathology predisposed to hemorrhage or associated with ongoing pharmacotherapy); * Recent (\< 3 months) intracranial or intraspinal surgery, major trauma, or stroke; * Known central nervous system neoplasm or metastatic cancer with high bleed risk. * Administration of systemic thrombolytic agents or catheter-directed thrombolysis prior to registry assessment for the index PE episode; * Known hypersensitivity to alteplase, unfractionated heparin (UFH), or any of their excipients. * Requirement for intensive care admission for conditions unrelated to the index PE; * Duration of symptoms attributable to the index PE \> 14 days at presentation, as defined in contemporary trial criteria; * Known severe thrombocytopenia (e.g., platelet count \< 100 × 10⁹/L) or coagulopathy precluding safe catheter access; * Life expectancy \< 6 months due to advanced comorbid disease unrelated to acute PE; * Pregnancy.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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National Medical Research Center for Cardiology named after academician Yevgeniy Chazov of the Ministry of Health of the Russian Federation
RECRUITINGMoscow, Russia
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Other studies related to the condition(s) this trial covers.
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