Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07452991

ULTRAsound-assisted Catheter-guided Thrombolysis for Intermediate-high Risk Patients With Pulmonary Embolism

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

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Pulmonary embolism (PE) is a serious and potentially fatal condition that ranks high among cardiovascular causes of death worldwide. Standard treatment for high-risk PE involves systemic thrombolysis, but this approach carries a significant bleeding risk and is not suitable for all patients. Researchers are evaluating catheter-directed thrombolysis (CDT) using the EkoSonic Endovascular System (EKOS) to assess its safety and effectiveness in patients with intermediate-high and high-risk PE, aiming to provide more controlled data on this treatment approach. In this study, 300 patients with intermediate-high risk PE who have no contraindications will receive ultrasound-assisted catheter-guided thrombolysis using the EKOS device. The treatment involves delivering a thrombolytic drug directly at the clot site with the help of ultrasound. The dosing and treatment regimen will be personalized based on decisions by the institutional heart team. This approach offers advantages like shorter infusion times and lower drug doses compared to systemic thrombolysis. Participants will be monitored through follow-up visits up to 360 days after treatment. The main measure of success is all-cause mortality assessed at multiple time points, including 48 hours, 7 days or discharge, and one year. Secondary outcomes include changes in heart and lung function measured by echocardiographic parameters such as the ratio of right to left ventricular size. Safety events like bleeding, stroke, and kidney injury will also be tracked throughout the study period.

CONDITIONS

Brief Title

ULTRAsound-assisted Catheter-guided Thrombolysis for Intermediate-high Risk Patients With PE

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 6 18 years at time of enrollment
  • Ability to provide written informed consent or consent by a legally authorized representative
  • Objectively confirmed acute pulmonary embolism by contrast-enhanced computed tomography pulmonary angiography
  • Hemodynamically stable at presentation (no sustained hypotension, shock, or vasopressor need)
  • Evidence of right ventricular dysfunction on imaging (RV/LV ratio > 1.0)
  • Elevated cardiac biomarkers above the upper limit of normal
  • Intermediate-high risk defined by imaging and biomarkers per ESC stratification
  • At least one clinical indicator of elevated early risk such as tachycardia (HR 6 100 bpm), mild systolic blood pressure reduction (SBP 4 110 mmHg but not high-risk), or hypoxemia (SpO2 < 90% on room air)
Not Eligible

You will not qualify if you...

  • Hemodynamic instability including systolic blood pressure < 90 mmHg or drop 6 40 mmHg for > 15 minutes not due to arrhythmia, hypovolemia, or sepsis
  • Need for vasopressors to maintain systolic blood pressure 6 90 mmHg
  • Cardiogenic shock with signs of end-organ hypoperfusion
  • Need for ECMO or other mechanical circulatory support before assessment
  • Cardiac arrest requiring resuscitation
  • Active major bleeding or high bleeding risk conditions
  • Recent intracranial or intraspinal surgery, major trauma, or stroke within 3 months
  • Known central nervous system neoplasm or metastatic cancer with high bleeding risk
  • Previous systemic thrombolytic or catheter-directed thrombolysis before registry assessment
  • Known hypersensitivity to alteplase, unfractionated heparin, or their excipients
  • Requirement for intensive care unrelated to PE
  • Duration of PE symptoms > 14 days at presentation
  • Severe thrombocytopenia or coagulopathy preventing safe catheter access
  • Life expectancy less than 6 months due to other advanced diseases
  • Pregnancy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - Procedure duration plus hospital stay until discharge

Participants undergo ultrasound-assisted catheter-guided thrombolysis using the EkoSonic Endovascular System to treat pulmonary embolism.

1 procedure visit and hospital monitoring

Post-operative Follow-up

Duration - Up to 360 days

Participants are monitored for clinical outcomes, safety, and echocardiographic parameters after the procedure.

Follow-up visits at 48 hours, day 7 or discharge, and at day 360

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

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Research Team

O

Oleg Dorogun, MD

N

Nikita Grishin, MD

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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Published Research Related To This Trial

Ultrasound-facilitated, catheter-directed thrombolysis vs anticoagulation alone for acute intermediate-high-risk pulmonary embolism: Rationale and design of the HI-PEITHO study.

Frederikus A Klok, Gregory Piazza, Andrew S P Sharp...

https://pubmed.ncbi.nlm.nih.gov/35588898

Catheter-directed thrombolysis compared with systemic thrombolysis and anticoagulation in patients with intermediate- or high-risk pulmonary embolism: systematic review and network meta-analysis.

David Planer, Stav Yanko, Ilan Matok...

https://pubmed.ncbi.nlm.nih.gov/37336568

Efficacy and Safety of Anticoagulation, Catheter-Directed Thrombolysis, or Systemic Thrombolysis in Acute Pulmonary Embolism.

Robert S Zhang, Muhammad H Maqsood, Andrew S P Sharp...

https://pubmed.ncbi.nlm.nih.gov/37855802

Randomized, controlled trial of ultrasound-assisted catheter-directed thrombolysis for acute intermediate-risk pulmonary embolism.

Nils Kucher, Peter Boekstegers, Oliver J Müller...

https://pubmed.ncbi.nlm.nih.gov/24226805

EkoSonic® endovascular system and other catheter-directed treatment reperfusion strategies for acute pulmonary embolism: overview of efficacy and safety outcomes.

Lukas Hobohm, Karsten Keller, Thomas Münzel...

https://pubmed.ncbi.nlm.nih.gov/32700589

Reduced-Dose Intravenous Thrombolysis for Acute Intermediate-High-risk Pulmonary Embolism: Rationale and Design of the Pulmonary Embolism International THrOmbolysis (PEITHO)-3 trial.

Olivier Sanchez, Anaïs Charles-Nelson, Walter Ageno...

https://pubmed.ncbi.nlm.nih.gov/34560806

2019 ESC Guidelines for the diagnosis and management of acute pulmonary embolism developed in collaboration with the European Respiratory Society (ERS).

Stavros V Konstantinides, Guy Meyer, Cecilia Becattini...

https://pubmed.ncbi.nlm.nih.gov/31504429