Ultrasound-guided catheter clot-dissolving treatment for adults with moderate-to-high risk pulmonary embolism

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective study will enroll adults with intermediate-high or high-risk acute pulmonary embolism and deliver ultrasound-assisted, catheter-directed thrombolysis using the EkoSonic Endovascular System (EKOS). The procedure uses targeted, lower-dose thrombolytic infusions directly into the pulmonary arteries with ultrasound to promote clot breakdown. The primary outcome is all-cause mortality through 360 days of follow-up, and secondary outcomes include changes in echocardiographic measures such as the RV/LV diameter ratio. The study will provide controlled data on safety and clinical outcomes for catheter-directed thrombolysis in this patient group.

Why it matters

Who can join: the full rules

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.

Where it's running

• National Medical Research Center for Cardiology named after academician Yevgeniy Chazov of the Ministry of Health of the Russian Federation
  Moscow, Russia Recruiting

Study contacts

• Principal investigator: Dmitry Pevzner, MD, D.Sc. — National Medical Research Center for Cardiology named after academician Yevgeniy Chazov of the Ministry of Health of the Russian Federation
• Study coordinator: Oleg Dorogun, MD
• Email: oleg.dorogun@gmail.com
• Phone: +7 919-764-2159

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Repeated exams to classify early pulmonary embolism

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• Using Acostream for treating high-risk pulmonary embolism

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• Reduced‑dose apixaban or rivaroxaban versus daily low‑molecular‑weight heparin for people with blood cancers

  This trial will test whether reduced‑dose apixaban or rivaroxaban pills can prevent blood clots as well and as safely as daily low‑molecular‑weight heparin injections in people with hematologic malignancies.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.