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Ultrasound device vs. blood thinners: which saves more lives from lung clots?

NCT ID NCT04790370

Disease control Sponsor: Boston Scientific Corporation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 02, 2026 · Updated 2 times

Summary

This study tests two treatments for people with intermediate-high risk pulmonary embolism (a serious blood clot in the lungs). Half receive standard blood thinners, and the other half get blood thinners plus a special ultrasound device that helps dissolve the clot. Researchers will track deaths, clot recurrence, and heart/lung complications over 12 months to see which approach works better.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
blood thinners (heparin) and the EkoSonic device (ultrasound-guided catheter to dissolve clots)
What this could lead to
If successful, this could show that combining ultrasound-guided clot removal with blood thinners is better than blood thinners alone for treating dangerous blood clots in the lungs.
What could go wrong
This is a Phase 4 trial, but results are not yet available. The added procedure carries risks like bleeding or vessel damage, and it may not prove superior to standard care.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

544 people

The number who actually took part.

Started

Aug 2021

Expected to finish

Aug 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age 18-80 years, inclusive * Objectively confirmed acute PE, based on computed tomography pulmonary angiography (CTPA) showing a filling defect in at least one main or proximal lobar pulmonary artery * Elevated risk of early death/hemodynamic collapse, indicated by at least two of the following new-onset clinical criteria: 1. ECG-documented tachycardia with heart rate ≥100 beats per minute, not due to hypovolemia, arrhythmia, or sepsis; 2. SBP ≤ 110 mm Hg for at least 15 minutes; 3. respiratory rate \> 20 x min\^-1 or oxygen saturation on pulse oximetry (SpO2) \< 90% (or partial arterial oxygen pressure \< 60 mmHg) at rest while breathing room air; * Right-to-left ventricular (RV/LV) diameter ratio ≥ 1.0 on CTPA * Serum troponin I or T levels above the upper limit of normal * Signed informed consent Exclusion Criteria: * Hemodynamic instability\*, i.e. at least one of the following present: 1. cardiac arrest or need for cardiopulmonary resuscitation; 2. need for ECMO, or ECMO initiated before randomization 3. PE-related shock, defined as: (i) SBP \< 90 mmHg, or vasopressors required to achieve SBP ≥ 90 mmHg, despite an adequate volume status; and (ii) end-organ hypoperfusion (altered mental status; oliguria/anuria; increased serum lactate); 4. isolated persistent hypotension (SBP \< 90 mmHg, or a systolic pressure drop by at least 40 mmHg for at least 15 minutes), not caused by new-onset arrhythmia, hypovolemia, or sepsis \* Patients who presented with temporary need for fluid resuscitation and/or low-dose catecholamines may be included, provided that they could be stabilized within 2 hours of admission and maintain SBP of ≥ 90 mmHg and adequate organ perfusion without catecholamine infusion. * Need for admission to an intensive care unit for a reason other than the index PE episode. NB: Patients who test positive for SARS-CoV-2 can be enrolled where the investigator believes that the pulmonary embolism is the dominant pathology in the patient's clinical presentation and qualifying cardiorespiratory parameters. * Temperature above 39 degrees C / 102.2 degrees F * Logistical reasons limiting the rapid availability of interventional procedures to treat acute PE (e.g., during the outbreak of an epidemic) * Index PE symptom duration \> 14 days * Active bleeding * History of intracranial or intraocular bleeding at any time * Stroke or transient ischemic attack within the past 6 months, or previous stroke at any time if associated with permanent disability * Central nervous system neoplasm, or metastatic cancer * Major neurologic, ophthalmologic, abdominal, cardiac, thoracic, vascular or orthopedic surgery or trauma (including syncope-associated with head strike or skeletal fracture) within the past 3 weeks * Platelet count \< 100 x 10\^9 x L\^-1 * Patients who have received a once-daily therapeutic dose of LMWH or a therapeutic dose of fondaparinux within 24 hours prior to randomization * Patients who have received one of the direct oral anticoagulants apixaban or rivaroxaban within 12 hours prior to randomization * Patients who have received one of the direct oral anticoagulants dabigatran or edoxaban for the index PE episode, as these drugs are not approved for patients who have not received heparin for at least 5 days * Administration of a thrombolytic agent or a glycoprotein IIb/IIIa receptor antagonist during the current hospital stay and/or within 30 days, for any reason * Chronic treatment with antiplatelet agents other than low-dose acetylsalicylic acid or clopidogrel 75 mg once daily (but not both). Dual antiplatelet therapy is excluded. * Chronic treatment with a direct oral anticoagulant (apixaban, dabigatran, edoxaban or rivaroxaban) * Chronic treatment with a vitamin K antagonist, or known coagulopathy including severe hepatic dysfunction, with an International Normalized Ratio (INR) \> 1.5 * Pregnancy or lactation * Previous inclusion in the study * Known hypersensitivity to alteplase, LMWH or UFH, or to any of the excipients * Life expectancy less than 6 months

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Conditions

The condition(s) this trial relates to.

pulmonary embolism

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pulmonary embolism

Contacts and locations

Locations

  • A.o. LKH Univ.-Kliniken Innsbruck

    Innsbruck, Austria

  • Allgemeines Krankenhaus AKH

    Vienna, Austria

  • Augusta University

    Augusta, Georgia, 30904, United States

  • Austria Klinik Ottakring Vienna

    Vienna, Austria

  • Baptist Health East Louisville

    Lousville, Kentucky, 40207, United States

  • CHU (Nimes Cedex)

    Nîmes, France

  • CHU de Besancon

    Besançon, France

  • Cedars - Sinai Medical Center

    Los Angeles, California, 90048, United States

  • Centre Hospitalier Universitaire Vaudois

    Lausanne, Switzerland

  • Christiana Hospital

    Newark, Delaware, 19718, United States

  • Columbia University Medical Center

    New York, New York, 10032, United States

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756, United States

  • Emory University Hospital

    Atlanta, Georgia, 30322, United States

  • GFO Kliniken Bonn

    Bonn, Germany

  • Henry Ford Hospital

    Detroit, Michigan, 48202, United States

  • Houston Methodist Sugarland Hospital

    Houston, Texas, 77479, United States

  • Hôpital Européen Georges Pompidou (HEGP)

    Paris, France

  • Johannes Gutenberg Universitaet Mainz

    Mainz, Germany

  • John Paul II Hospital

    Krakow, Poland

  • Kettering Health

    Kettering, Ohio, 45429, United States

  • Klinik Immenstadt

    Immenstädt, Germany

  • Klinikum Bielefeld

    Bielefeld, Germany

  • Klinikum Chemnitz

    Chemnitz, Germany

  • Klinikum Rechts der Isar

    Munich, Germany

  • Leiden University Medical Center

    Leiden, Netherlands

  • Lenox Hill Hospital

    New York, New York, 10075, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Mater Misericordiae University Hospital

    Dublin, Ireland

  • Medical University of Warsaw

    Warsaw, Poland

  • Methodist Hospitals

    Merrillville, Indiana, 46410, United States

  • Mount Sinai Medical Center

    New York, New York, 10029, United States

  • Nebraska Methodist Hospital

    Omaha, Nebraska, 68114, United States

  • Newark Beth Israel Medical Center

    Newark, New Jersey, 07112, United States

  • North Mississippi Medical Center

    Tupelo, Mississippi, 38801, United States

  • Northwick Park Hospital

    Middlesex, United Kingdom

  • Piedmont Hospital

    Atlanta, Georgia, 30309, United States

  • Seton Medical Center

    Austin, Texas, 78705, United States

  • St. Antonius Ziekenhuis

    Nieuwegein, Netherlands

  • The Heart Hospital Baylor Plano

    Plano, Texas, 75093, United States

  • The Royal Free Hospital

    London, United Kingdom

  • Uniklinik Aachen

    Aachen, Germany

  • Universitaetsklinikum Freiburg

    Freiburg im Breisgau, Germany

  • Universitaetsklinikum Schleswig-Holstein

    Lübeck, Germany

  • Universitaetsklinikum Tuebingen

    Tübingen, Germany

  • Universitaetsklinikum Wuerzburg

    Würzburg, Germany

  • Universitair Medisch Centrum

    Utrecht, Netherlands

  • University Hospital Basel

    Basel, Switzerland

  • University Hospital Galway

    Galway, Ireland

  • University Hospital Zurich

    Zurich, Switzerland

  • University Hospital of Wales

    Cardiff, United Kingdom

  • University Hospitals of Cleveland

    Cleveland, Ohio, 44106, United States

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294, United States

  • University of Maryland School of Medicine

    Baltimore, Maryland, 21201, United States

  • University of Michigan Hospitals

    Ann Arbor, Michigan, 48109, United States

  • University of Virginia Medical Center

    Charlottesville, Virginia, 22908, United States

  • University of Wisconsin Hospitals

    Madison, Wisconsin, 53792, United States

  • Universitätsklinikum St. Pölten

    Sankt Pölten, Austria

  • Uniwersytecki Szpital Kliniczny w Poznaniu

    Poznan, Poland

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232, United States

  • Wellmont Holston Valley Medical Center

    Kingsport, Tennessee, 37660, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.