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Pulmonary Embolism (PE)ULTRA-PENCT07452991

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

A study testing Ultrasound-assisted Catheter-guided Thrombolysis in people with Pulmonary Embolism (PE), run by National Medical Research Center for Cardiology, Ministry of Health of Russian Federation at 1 site in Russia.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pulmonary Embolism (PE)
What is being tested?
Ultrasound-assisted Catheter-guided Thrombolysis
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
1 siteRussia
Study dates
10 Sep 2024to 10 Sep 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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:
  • Tachycardia (e.g., HR ≥ 100 bpm),
  • Mild systolic blood pressure reduction (e.g., SBP ≤ 110 mmHg but not meeting high-risk thresholds),
  • Hypoxemia (SpO₂ < 90% on room air).

Who cannot join

  • Presence of hemodynamic instability, defined as at least one of the following:
  • 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,
  • Cardiac arrest requiring resuscitation.
Show all 16Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Oleg Dorogun, MD contact

+7 919-764-2159

oleg.dorogun@gmail.com

Nikita Grishin, MD contact

+7 977-579-9185

n.s.grishin@mail.ru

Russia1 site, 1 recruiting

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

    Moscow

    Ilia Zyuryaev, +7-903-260-49-72, zyuryaev@list.ru

    Nikita Grishin, +7-977-579-9185, n.s.grishin@mail.ru

    Recruiting

Other trials in Russia

About this study

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

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.

Read the detailed description

Pulmonary embolism (PE) is an acute, life-threatening condition, ranking as the third leading cause of mortality from cardiovascular diseases worldwide. The main approach for treating high-risk PE is systemic thrombolysis, however due to the associated risk of major hemorrhage, its use is contraindicated in certain patient populations, underscoring the need for alternative reperfusion strategies.

In recent years, catheter-directed thrombolysis (CDT) have been increasingly used in the treatment of PE due to a number of advantages including shorter infusion duration, lower doses of thrombolytic drugs leading to a more rapid achievement of therapeutic effect. Among all CDT, the most cost-effective are in situ and ultrasound-assisted thrombolysis, with only the latter being available in the Russian Federation. This prospective study will include patients with intermediate-high and high-risk PE treated with CDT, specifically EkoSonic Endovascular System (EKOS; Boston Scientific). The findings of this study will add to the current body of evidence regarding the management and outcomes of patients with acute intermediate-high risk PE, and will provide controlled data on CDT approaches.

The primary outcome will include all-cause mortality at day 7 after procedure or at discharge, if earlier, to day 360 of follow-up. The secondary outcome will include echocardiographic parameters, e.g. the change in RV/LV diameter ratio from baseline to first outpatient follow-up.

Being tested
Ultrasound-assisted Catheter-guided Thrombolysis
Keywords
Pulmonary embolism, Ultrasound-assisted Catheter-guided Thrombolysis
Medical subject headings
Pulmonary Embolism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ultrasound-assisted Catheter-guided ThrombolysisDevice

    The 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.

Study groups in NCT07452991
Study groupRoleWhat they receive
Safety and clinical efficacy of EKOS in intermediate-high risk patients with PEExperimentalA total of 300 patients with intermediate-high risk pulmonary embolism (PE) and no contraindications to ultrasound-assisted catheter-directed thrombolysis will be enrolled. All enrolled patients will undergo thrombolytic therapy using the EkoSonic™ Endovascular System, which provides ultrasound-facilitated catheter-directed delivery of a thrombolytic agent. The total thrombolytic dose and dosing regimen will be determined by the institutional heart team.
Receives: Device: Ultrasound-assisted Catheter-guided Thrombolysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. All-cause mortality

    Total number of deaths from any cause.

    Measured: 48 hours post-procedure. At day 7 after procedure or at discharge, if earlier. At day 360 of follow-up.

  2. 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

    Measured: 48 hours post-procedure. At day 7 after procedure or at discharge, if earlier. At day 360 of follow-up.

Secondary outcomes (16)

  1. 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.

    Measured: At admission; 48 hours post-procedure; Day 7 post-procedure or discharge (whichever occurs first)

  2. 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.

    Measured: Baseline; 48 hours; Day 7/discharge

  3. Systolic Pulmonary Artery Pressure (sPAP)

    Measured by transthoracic echocardiography, estimated from tricuspid regurgitation velocity. Reflects pulmonary hypertension severity.

    Measured: Baseline; 48 hours; Day 7/discharge

  4. Basal Right Ventricular Diameter (cm)

    Measured by transthoracic echocardiography

    Measured: Baseline; 48 hours; Day 7/discharge

  5. Tricuspid Annular Plane Systolic Excursion (TAPSE, cm)

    Measured by transthoracic echocardiography

    Measured: Baseline; 48 hours; Day 7/discharge

  6. Inferior Vena Cava (IVC) Diameter and Collapsibility

    Measured by transthoracic echocardiography

    Measured: Baseline; 48 hours; Day 7/discharge

  7. Number of participants with cardiogenic shock

    As defined by SCAI-CSWG 2022

    Measured: From the beginning of the procedure until its conclusion. Within 48 hours post-procedure. At day 7 after procedure or at discharge, if earlier.

  8. Number of participants with major bleeding

    Major bleeding (BARC 3 to 5) after procedure, according to the BARC Bleeding Classification 2011.

    Measured: At 48 hours post-procedure. At day 7 after PCI or at discharge, if earlier.

  9. Number of patients requiring blood transfusion

    Any transfusion of packed red blood cells.

    Measured: Within 48 hours; during hospitalization

  10. Number of participants with stroke or transient ischemic attack

    As per VARC 2 definitions 2013.

    Measured: 48 hours post-procedure. At day 7 after procedure or at discharge, if earlier.

  11. Intra-Procedural Mortality

    Death occurring during catheter-directed thrombolysis.

    Measured: During procedure

  12. Number of patients with Unsuccessful Catheter Placement

    Failure to achieve proper catheter positioning or device deployment.

    Measured: During procedure

  13. Number of patients with acute kidney injury (AKI)

    Defined according to KDIGO criteria.

    Measured: Within 48 hours post-procedure. At day 7 after procedure or at discharge, if earlier.

  14. Number of patients requiring cardiopulmonary resuscitation

    Measured: During procedure. 48 hours post-procedure. At day 7 after procedure or at discharge, if earlier.

  15. Recurrent Pulmonary Embolism

    Nonfatal symptomatic and objectively confirmed recurrence of PE

    Measured: At day 360 of follow-up.

  16. Development of Chronic Thromboembolic Pulmonary Hypertension

    Chronic thromboembolic pulmonary hypertension will be confirmed at the investigational site if all of the following criteria are fulfilled:

    • Presence of at least one mismatched segmental perfusion defect identified on ventilation/perfusion (V/Q) scintigraphy following a minimum of 3 months of adequate therapeutic anticoagulation.
    • Resting mean pulmonary arterial pressure (mPAP) ≥ 25 mmHg, as determined by invasive right heart catheterization.
    • Pulmonary capillary wedge pressure (PCWP) ≤ 15 mmHg.

    Measured: At day 360 of follow-up.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2026
  2. Study start10 Sep 2024
  3. Primary completion10 Sep 2029 (estimated)
  4. Study completion10 Sep 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
300 patients with intermediate-high risk pulmonary embolism (PE) and no contradictions for ultrasound-assisted catheter-guided thrombolysis will be enrolled. The risk of PE will be assessed by the institution's heart team. Patients participating in the clinical trial are expected to remain hospitalized for approximately 7-14 days and will be followed for 360 days (with an acceptable range of 350-370 days) after the intervention or until the occurrence of the primary endpoint.
Masking
None (open label)
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07452991
Sponsor's protocol ID
2024-09-10
Acronym
ULTRA-PE
Status last verified
Mar 2026
First submitted
1 Mar 2026
Last updated
17 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Klok FA, Piazza G, Sharp ASP, Ni Ainle F, Jaff MR, Chauhan N, Patel B, Barco S, Goldhaber SZ, Kucher N, Lang IM, Schmidtmann I, Sterling KM, Becker D, Martin N, Rosenfield K, Konstantinides SV. Ultrasound-facilitated, catheter-directed thrombolysis vs anticoagulation alone for acute intermediate-high-risk pulmonary embolism: Rationale and design of the HI-PEITHO study. Am Heart J. 2022 Sep;251:43-53. doi: 10.1016/j.ahj.2022.05.011. Epub 2022 May 16.

    PubMed 35588898

  • Planer D, Yanko S, Matok I, Paltiel O, Zmiro R, Rotshild V, Amir O, Elbaz-Greener G, Raccah BH. Catheter-directed thrombolysis compared with systemic thrombolysis and anticoagulation in patients with intermediate- or high-risk pulmonary embolism: systematic review and network meta-analysis. CMAJ. 2023 Jun 19;195(24):E833-E843. doi: 10.1503/cmaj.220960.

    PubMed 37336568

  • Tefera L, Ziada KM, Cameron SJ. Pulmonary Embolism Unplugged: Catheter-Directed Therapies for Intermediate-Risk Pulmonary Embolism. JACC Cardiovasc Interv. 2023 Nov 13;16(21):2652-2654. doi: 10.1016/j.jcin.2023.08.029. Epub 2023 Oct 18. No abstract available.

    PubMed 37855803

  • Zhang RS, Maqsood MH, Sharp ASP, Postelnicu R, Sethi SS, Greco A, Alviar C, Bangalore S. Efficacy and Safety of Anticoagulation, Catheter-Directed Thrombolysis, or Systemic Thrombolysis in Acute Pulmonary Embolism. JACC Cardiovasc Interv. 2023 Nov 13;16(21):2644-2651. doi: 10.1016/j.jcin.2023.07.042. Epub 2023 Oct 18.

    PubMed 37855802

  • Kucher N, Boekstegers P, Muller OJ, Kupatt C, Beyer-Westendorf J, Heitzer T, Tebbe U, Horstkotte J, Muller R, Blessing E, Greif M, Lange P, Hoffmann RT, Werth S, Barmeyer A, Hartel D, Grunwald H, Empen K, Baumgartner I. Randomized, controlled trial of ultrasound-assisted catheter-directed thrombolysis for acute intermediate-risk pulmonary embolism. Circulation. 2014 Jan 28;129(4):479-86. doi: 10.1161/CIRCULATIONAHA.113.005544. Epub 2013 Nov 13.

    PubMed 24226805

  • Hobohm L, Keller K, Munzel T, Gori T, Konstantinides SV. EkoSonic(R) endovascular system and other catheter-directed treatment reperfusion strategies for acute pulmonary embolism: overview of efficacy and safety outcomes. Expert Rev Med Devices. 2020 Aug;17(8):739-749. doi: 10.1080/17434440.2020.1796632. Epub 2020 Jul 29.

    PubMed 32700589

  • Sanchez O, Charles-Nelson A, Ageno W, Barco S, Binder H, Chatellier G, Duerschmied D, Empen K, Ferreira M, Girard P, Huisman MV, Jimenez D, Katsahian S, Kozak M, Lankeit M, Meneveau N, Pruszczyk P, Petris A, Righini M, Rosenkranz S, Schellong S, Stefanovic B, Verhamme P, de Wit K, Vicaut E, Zirlik A, Konstantinides SV, Meyer G; PEITHO-3 Investigators. Reduced-Dose Intravenous Thrombolysis for Acute Intermediate-High-risk Pulmonary Embolism: Rationale and Design of the Pulmonary Embolism International THrOmbolysis (PEITHO)-3 trial. Thromb Haemost. 2022 May;122(5):857-866. doi: 10.1055/a-1653-4699. Epub 2021 Oct 31.

    PubMed 34560806

  • Konstantinides SV, Meyer G, Becattini C, Bueno H, Geersing GJ, Harjola VP, Huisman MV, Humbert M, Jennings CS, Jimenez D, Kucher N, Lang IM, Lankeit M, Lorusso R, Mazzolai L, Meneveau N, Ni Ainle F, Prandoni P, Pruszczyk P, Righini M, Torbicki A, Van Belle E, Zamorano JL; ESC Scientific Document Group. 2019 ESC Guidelines for the diagnosis and management of acute pulmonary embolism developed in collaboration with the European Respiratory Society (ERS). Eur Heart J. 2020 Jan 21;41(4):543-603. doi: 10.1093/eurheartj/ehz405. No abstract available.

    PubMed 31504429

Questions about this trial

What is this clinical trial studying?

A study testing Ultrasound-assisted Catheter-guided Thrombolysis in people with Pulmonary Embolism (PE), run by National Medical Research Center for Cardiology, Ministry of Health of Russian Federation at 1 site in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Oleg Dorogun, MD (+7 919-764-2159, oleg.dorogun@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All-cause mortality (time frame: 48 hours post-procedure. At day 7 after procedure or at discharge, if earlier. At day 360 of follow-up.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07452991, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.

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