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New device aims to beat standard care for dangerous lung clots

NCT ID NCT05111613

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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tested a device called FlowTriever that mechanically removes blood clots from the lungs, comparing it to standard clot-dissolving drugs (catheter-directed thrombolysis). 692 patients with acute pulmonary embolism were enrolled. The goal was to see which treatment leads to fewer deaths, bleeding complications, and shorter ICU stays.

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 (mechanical thrombectomy device)
What this could lead to
If successful, this could show that mechanical removal of blood clots is safer and more effective than clot-dissolving drugs for pulmonary embolism.
What could go wrong
This is a completed trial, but results are not yet published. The comparison is against an existing treatment, so benefits may be modest. Risks include bleeding or device-related complications.

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

692 people

The number who actually took part.

Started

Feb 2022

Finished

Apr 2024

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 Subjects must meet each of the following criteria to be included in the study: * Age ≥ 18 years * Echo, computed tomographic pulmonary angiography (CTPA), or pulmonary angiographic evidence of any proximal filling defect in at least one main or lobar pulmonary artery * Including ALL of the following: Clinical signs and symptoms consistent with acute PE, or PESI class III-V, or sPESI ≥1; AND Hemodynamically stable AND; RV dysfunction on echocardiography or CT; AND Any one or more of the following present at the time of diagnosis: Elevated cardiac troponin levels; History of heart failure; History of chronic lung disease; Heart rate ≥110 beats per minute; SBP \<100mmHg; Respiratory rate ≥30 breaths per minute; O2 saturation \<90%; Syncope related to PE; Elevated Lactate * Intervention planned to begin within 72 hours of the later of either: confirmed PE diagnosis; OR if transferring from another hospital, arrival at the treating hospital * Symptom onset within 14 days of confirmed PE diagnosis Exclusion Criteria Subjects will be excluded from the study for any of the following criteria: * Unable to anticoagulate with heparin, enoxaparin or other parenteral antithrombin * Index presentation with hemodynamic instability that are part of the high-risk PE definition in the ESC Guidelines 2019, including ANY of the following: cardiac arrest; OR systolic BP \< 90 mmHg or vasopressors required to achieve a BP ≥90 mmHg despite adequate filling status, AND end-organ hypoperfusion; OR systolic BP \< 90 mmHg or systolic BP drop ≥40 mmHg, lasting longer than 15 min and not caused by new-onset arrhythmia, hypovolemia, or sepsis * Known sensitivity to radiographic contrast agents that, in the Investigator's opinion, cannot be adequately pre-treated * Imaging evidence or other evidence that suggests, in the opinion of the Investigator, the patient is not appropriate for catheter-based intervention (e.g. inability to navigate to target location, clot limited to segmental/subsegmental distribution, predominately chronic clot) * Patient has right heart clot in transit identified at baseline screening * Life expectancy \< 30 days (e.g. stage 4 cancer or severe COVID-19 infection), as determined by the Investigator * Current participation in another drug or device study that, in the Investigator's opinion, would interfere with participation in this study * Current or history of chronic thromboembolic pulmonary hypertension (CTEPH) or chronic thromboembolic disease (CTED) diagnosis, per ESC 2019 guidelines * Invasive systolic PA pressure ≥70 mmHg prior to study device entering the body * Administration of bolus or drip/infusion thrombolytic therapy or mechanical thrombectomy for the index PE event within 48 hours prior to enrollment * Ventricular arrhythmias refractory to treatment at the time of enrollment * Known to have heparin-induced thrombocytopenia (HIT) * 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). This includes a contraindication to use of FlowTriever or CDT System (for example, EKOS System) per local approved labeling * Subject has previously completed or withdrawn from this study * Patient unwilling or unable to conduct the follow up visits per protocol.

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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

Contacts and locations

Locations

  • AHN Saint Vincent Hospital

    Erie, Pennsylvania, 16544, United States

  • Advocate Christ Medical Center

    Oak Lawn, Illinois, 60453, United States

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212, United States

  • Ascension Alexian Brothers Medical Center

    Elk Grove Village, Illinois, 60007, United States

  • Ascension Saint Thomas Hospital

    Nashville, Tennessee, 37205, United States

  • Ascension St. Elizabeth Hospital

    Appleton, Wisconsin, 54915, United States

  • Ascension St. John Hospital

    Detroit, Michigan, 48236, United States

  • Ascension St. Vincent Hospital - Indianapolis

    Indianapolis, Indiana, 46260, United States

  • Aurora St. Luke's Medical Center

    Milwaukee, Wisconsin, 53215, United States

  • Baptist Health South Florida

    Miami, Florida, 33176, United States

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215, United States

  • Brigham and Womens Hospital

    Boston, Massachusetts, 02115, United States

  • CentraCare St. Cloud Hospital

    Saint Cloud, Minnesota, 56303, United States

  • Emory University

    Atlanta, Georgia, 30322, United States

  • Gates Vascular Institute

    Buffalo, New York, 14203, United States

  • Gundersen Health System

    La Crosse, Wisconsin, 54601, United States

  • HCA Medical City Heart and Spine

    Dallas, Texas, 75243, United States

  • HCA TriStar Centennial Medical Center

    Nashville, Tennessee, 37203, United States

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601, United States

  • Herzzentrum Leipzig

    Leipzig, Germany

  • Houston Methodist Hospital

    Houston, Texas, 77030, United States

  • Huntington Hospital

    Pasadena, California, 91105, United States

  • Inselspital - Universitätsspital Bern

    Bern, 3010, Switzerland

  • Lexington Medical Center

    West Columbia, South Carolina, 29169, United States

  • Loma Linda University Health

    Loma Linda, California, 92354, United States

  • MUSC Health University Medical Center

    Charleston, South Carolina, 29425, United States

  • Marien Hospital Wesel GmbH

    Wesel, Germany

  • Memorial Hermann Medical Center

    Houston, Texas, 77030, United States

  • Mercy Health West

    Cincinnati, Ohio, 45211, United States

  • Methodist Main Hospital

    San Antonio, Texas, 78229, United States

  • NewYork-Presbyterian Columbia University Irving Medical Center

    New York, New York, 10032, United States

  • Northwell Health

    Bay Shore, New York, 11706, United States

  • Norton Healthcare

    Louisville, Kentucky, 40202, United States

  • Novant Health New Hanover Regional Medical Center

    Wilmington, North Carolina, 28401, United States

  • OhioHealth Riverside Methodist Hospital

    Columbus, Ohio, 43214, United States

  • Providence Sacred Heart Medical Center

    Spokane, Washington, 99204, United States

  • Providence St. Joseph Orange

    Orange, California, 92868, United States

  • Radiology and Imaging Associates

    Lakeland, Florida, 33801, United States

  • Saint Louis University

    St Louis, Missouri, 63104, United States

  • Saint Luke's Hospital of Kansas City

    Kansas City, Missouri, 64111, United States

  • Sarasota Memorial Hospital

    Sarasota, Florida, 34239, United States

  • Sentara Norfolk General Hospital

    Norfolk, Virginia, 23507, United States

  • Spartanburg Regional Healthcare System

    Spartanburg, South Carolina, 29303, United States

  • St. Luke's University Hospital

    Bethlehem, Pennsylvania, 18015, United States

  • Summa Akron City Hospital

    Akron, Ohio, 44304, United States

  • Tallahassee Memorial Hospital

    Tallahassee, Florida, 32308, United States

  • Temple University Hospital

    Philadelphia, Pennsylvania, 19140, United States

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19108, United States

  • UPMC Harrisburg

    Harrisburg, Pennsylvania, 17101, United States

  • UPMC Presbyterian

    Pittsburgh, Pennsylvania, 19140, United States

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106, United States

  • University of Colorado Hospital

    Aurora, Colorado, 80045, United States

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216, United States

  • University of North Carolina Health

    Chapel Hill, North Carolina, 27514, United States

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • University of Rochester Medical Center

    Rochester, New York, 14642, United States

  • University of South Florida Tampa General Hospital

    Tampa, Florida, 33606, United States

  • Universtitaetsklinikum Dusseldorf

    Düsseldorf, Germany

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232, United States

  • Virtua Lourdes

    Camden, New Jersey, 08103, United States

More trials for these conditions

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