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New device aims to tackle deadly lung clots

NCT ID NCT06588634

Disease control Sponsor: Inari Medical 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 11, 2026 · Updated 5 times

Summary

This study is testing a device called FlowTriever that removes blood clots from the lungs in people with a severe, high-risk pulmonary embolism. About 200 participants will be randomly assigned to get either the device or standard care. The goal is to see if the device reduces death, cardiac arrest, major bleeding, and the need for life support.

What this could mean

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

Active substance
FlowTriever System (a device that removes blood clots from the lungs)
What this could lead to
If successful, this could provide a more effective treatment for high-risk pulmonary embolism, potentially reducing death and complications.
What could go wrong
This is a relatively early-stage study with 200 participants. The device may not prove better than standard care, and there are risks like major bleeding or need for additional procedures.

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 200 people

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

Started

Dec 2024

Expected to finish

Feb 2028

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 years and older

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. Age at enrollment ≥18 years 2. Objective evidence of a proximal filling defect in at least one main or lobar pulmonary artery 3. High-risk class of acute PE 4. RV dysfunction, as defined RV/LV ratio ≥1.0 5. Willing and able to provide informed consent, or if unable, through a Legal Authorized Representative, with permitting research without prior consent as a third option (for Europe and UK sites only), provided compliance with IRB/EC approvals and adherence to regulatory, ethical and national standards Exclusion Criteria: 1. Prolonged cardiac arrest with loss of consciousness associated with neurological deficit. 2. Imaging evidence or other evidence that suggests, in the opinion of the Investigator, the patient is not appropriate for catheter-based intervention 3. Known pre-existing CTEPH, or CT signs of chronic PE that may point to pre-existing CTEPH 4. Recent stroke (\<14 days) 5. Recent cranial or spinal surgery (\<14 days) 6. Life-threatening active bleeding or hemorrhage into a critical area 7. Known intracranial tumor 8. End-stage medical condition with life expectancy \<3 months (irrespective of the severity of acute PE), as determined by the Investigator 9. Known sensitivity to radiographic contrast agents that, in the Investigator's opinion, cannot be adequately pre-treated 10. Inability to anticoagulate the patient, or known to have heparin-induced thrombocytopenia (HIT) 11. Current participation in another drug or device study that may interfere with the conduct of this trial 12. Ventricular arrhythmias refractory to treatment at the time of enrollment 13. Subject has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject (e.g., compromise the well-being or that could prevent, limit, or confound the protocol-specified assessments), including a contraindication to use of FlowTriever System per local approved labeling 14. Subject is part of a vulnerable population (e.g., currently pregnant, breastfeeding or incarcerated) per local definitions 15. Subject was previously enrolled in this study 16. Subject has received prior thrombolytic (systemic or catheter-directed) therapy for any reason or thrombectomy (surgical or catheter-based) therapy for index PE, within 30 days prior to randomization

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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 Pulmonary thromboembolism

How to take part

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

  1. The places running it

    29 sites in 6 countries. 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 Orlando

    RECRUITING

    Orlando, Florida, 32803, United States

  • Allegheny General Hospital

    RECRUITING

    Pittsburgh, Pennsylvania, 15212, United States

  • Besançon University Hospital

    RECRUITING

    Besançon, 25030, France

  • CHU Grenoble Alpes

    RECRUITING

    La Tronche, 38700, France

  • CHU Nîmes Caremeau

    RECRUITING

    Nîmes, France

  • Emory University

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • HCA Medical City Heart & Spine

    RECRUITING

    Dallas, Texas, 75039, United States

  • HCA Methodist Health San Antonio

    RECRUITING

    San Antonio, Texas, 78229, United States

  • HCA Tristar/Centennial

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Hopital Arnaud de Villeneuve, Montpellier

    RECRUITING

    Montpellier, France

  • Hospital Universitari Vall d'Hebron, Barcelona

    RECRUITING

    Barcelona, Spain

  • Hospital Universitario La Paz Madrid

    RECRUITING

    Madrid, 28046, Spain

  • Hôpital Européen Georges-Pompidou, Paris

    RECRUITING

    Paris, France

  • Klinikum Chemnitz

    RECRUITING

    Chemnitz, Germany

  • Munich LMU

    RECRUITING

    München, Germany

  • Northwell Health

    RECRUITING

    Bay Shore, New York, 11706, United States

  • Orlando Health Regional Medical Center

    RECRUITING

    Orlando, Florida, 32806, United States

  • Royal Free Hospital London

    RECRUITING

    London, United Kingdom

  • SUNY, The University at Buffalo

    RECRUITING

    Buffalo, New York, 14203, United States

  • Sarasota Memorial Hospital

    RECRUITING

    Sarasota, Florida, 34239, United States

  • Summa Akron

    RECRUITING

    Akron, Ohio, 44304, United States

  • UPHS Penn Health System

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • UPMC

    RECRUITING

    Pittsburgh, Pennsylvania, 152123, United States

  • University Hospital Basel

    RECRUITING

    Basel, 4031, Switzerland

  • University of Mississippi Medical Center

    RECRUITING

    Jackson, Mississippi, 39216, United States

  • Universitätsklinik Regensburg

    RECRUITING

    Regensburg, Germany

  • Universitätsklinikum Carl Gustav Carus an der TU Dresden

    RECRUITING

    Dresden, Germany

  • Universitätsmedizin Mainz

    RECRUITING

    Mainz, 55131, Germany

  • Yale University

    RECRUITING

    New Haven, Connecticut, 06519, United States

More trials for these conditions

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