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New Clot-Busting device could change how we treat dangerous lung clots

NCT ID NCT06041594

Disease control Sponsor: Innova Vascular, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jul 17, 2026 · Updated 2 times

Summary

This study tests a new device called the Laguna Thrombectomy System to remove blood clots from the lungs in people with pulmonary embolism. About 107 adults with moderate to severe clots will be treated, and doctors will check for safety and effectiveness within 48 hours. The goal is to see if the device can quickly clear the blockage without causing major bleeding or other serious problems.

What this could mean

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

Active substance
Laguna Thrombectomy System (a device to remove blood clots from the lungs)
What this could lead to
If successful, this device could offer a new, less invasive way to quickly remove dangerous blood clots from the lungs, potentially reducing complications and improving recovery for people with pulmonary embolism.
What could go wrong
This is an early-stage study with only 107 participants, so results may not apply to everyone. There are risks of bleeding, heart or lung injury, and the device may not work better than existing treatments.

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

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

About 107 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2024

Expected to finish

Sep 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 85 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: 1. ≥ 18 years of age; \< 85 years old 2. RV/LV ratio \> 0.9 as determined by CTA 3. Systolic blood pressure \> 90 mmHg 4. Heart rate ≤ 120 5. Patient is deemed eligible for procedure by the interventional investigator 6. CTA evidence of proximal PE (filling defect in at least one main or lobar pulmonary artery) 7. PE Symptom duration ≤ 14 days Exclusion Criteria: 1. Systolic pulmonary artery pressure \> 70 mmHg on initial invasive hemodynamic assessments 2. Life expectancy of \< 90 days in the opinion of investigator at the time of enrollment 3. Subject pregnant or breast feeding 4. Current participation in another drug or medical device treatment study 5. In active chemotherapy or radiation treatment for a malignancy during the course of the study 6. Any intravascular administration of a fibrinolytic agent (such as Alteplase or Tenecteplase) within the last 30 days 7. Presence of recently placed (\<8 weeks) intracardiac devices (such as pacemaker leads) in the right ventricle or right atrium 8. History of prior PE within the past 90 days 9. FiO2 Requirement: \> 40% (6 LPM) to keep oxygen saturation \> 90% 10. Hematocrit: \< 28% 11. Platelets: \< 100,000/microliter 12. Serum Creatinine: \> 2 mg/dL 13. International Normalized Ratio (INR): \> 3 14. Major Trauma Injury Severity Score (ISS): \> 15 15. Cardiovascular or pulmonary surgery within the last 7 days 16. Known bleeding diathesis or coagulation disorder that cannot be managed with anti-coagulation 17. History of known severe or chronic pulmonary arterial hypertension 18. History or chronic left heart disease with left ventricular ejection fraction \< 30% 19. History of underlying lung disease that is oxygen dependent 20. History of chest irradiation 21. Known anaphylactic reaction to radiographic contrast agents that cannot be pretreated 22. Any absolute contraindication to systemic or therapeutic dosage of heparin or anticoagulants 23. Imaging or other evidence that suggests, in the opinion of the investigator, the subject is not appropriate for mechanical thrombectomy intervention (e.g., inability to navigate to target location, predominantly chronic clot or non-clot embolus) 24. Known presence of clot in transit within right atrium or ventricle

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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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    13 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • AdventHealth Tampa

    COMPLETED

    Tampa, Florida, 33613, United States

  • Albany Medical Center

    COMPLETED

    Albany, New York, 12210, United States

  • Ankara Bilkent City Hospital

    COMPLETED

    Ankara, Turkey (Türkiye)

  • Ankara Etlik City Hospital

    COMPLETED

    Ankara, Turkey (Türkiye)

  • Dokuz Eylul University Research and Application Hospital

    COMPLETED

    Izmir, Turkey (Türkiye)

  • George Washington University

    RECRUITING

    Washington D.C., District of Columbia, 20037, United States

  • Grandview Medical Center

    RECRUITING

    Birmingham, Alabama, 35243, United States

  • Hacettepe University Hospital

    COMPLETED

    Ankara, Turkey (Türkiye)

  • Manatee Memorial Hospital

    RECRUITING

    Bradenton, Florida, 34209, United States

  • Memorial Care Long Beach Medical Center

    RECRUITING

    Long Beach, California, 90806, United States

  • Mission Hospital Regional Medical Center

    RECRUITING

    Mission Viejo, California, 92691, United States

  • OhioHealth Research Institute

    RECRUITING

    Columbus, Ohio, 43214, United States

  • Physicians Regional Medical Center

    RECRUITING

    Naples, Florida, 34119, United States

  • Rush University Medical Center

    COMPLETED

    Chicago, Illinois, 60612, United States

  • Sancaktepe Sehit Prof. Dr. Ilhan Varank Training and Research Hospital

    COMPLETED

    Istanbul, Turkey (Türkiye)

  • St. Joseph Hospital of Orange

    RECRUITING

    Orange, California, 92868, United States

  • Turkey Creek Medical Center

    RECRUITING

    Knoxville, Tennessee, 37934, United States

  • University of Arizona

    RECRUITING

    Tucson, Arizona, 85724, United States

  • University of California Irvine

    RECRUITING

    Irvine, California, 92697, United States

  • University of North Carolina at Chapel Hill

    RECRUITING

    Chapel Hill, North Carolina, 27599, United States

  • University of Texas Southwestern

    RECRUITING

    Dallas, Texas, 75390, United States

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