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New device shows promise for treating dangerous lung clots

NCT ID NCT03761173

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looked at a device called the FlowTriever, which is used to remove blood clots from the lungs in people with a serious condition called acute pulmonary embolism. Researchers followed 1,200 patients to see how safe and effective the device was in real-world use. The goal was to track major problems like death, major bleeding, or injury to the lungs or heart within 48 hours of the procedure.

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 to remove blood clots from lung arteries) and anticoagulation medication
What this could lead to
If successful, this could confirm that the FlowTriever device is a safe and effective way to treat acute pulmonary embolism, potentially reducing complications and improving recovery.
What could go wrong
This is a registry study, not a randomized trial, so results may be influenced by patient selection. The device carries risks like bleeding or injury to blood vessels, and it may not work for all patients.

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.

Participants

1,200 people

The number who actually took part.

Started

Dec 2018

Finished

Sep 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.

Who is studied

Patients requiring treatment for pulmonary embolism.

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: * Clinical signs and symptoms consistent with acute PE * Echo, CTPA or pulmonary angiographic evidence of proximal filling defect in at least one main or lobar pulmonary artery * Scheduled for PE treatment with the FlowTriever System per the Investigator's discretion\* * US only: Patients enrolled in the Conservative Therapy Sub-study are not required to meet this inclusion criteria but must instead be scheduled for primary anticoagulation therapy as the primary treatment strategy. Exclusion Criteria: * Unable to be anticoagulated with heparin or alternative * Diagnosis with a minor PE with a less than 0.9 RV/LV ratio * 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 Investigator's opinion, the subject is not appropriate for mechanical thrombectomy intervention\* * Life expectancy \< 30 days, as determined by Investigator * Current participation in another investigational drug or device treatment study that, in the Investigator's opinion, would interfere with participation in this study * US Only Patients enrolled in the Conservative Therapy Sub-study are not required to meet these exclusion criteria

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Conditions

The condition(s) this trial relates to.

pulmonary embolism Thromboembolism

As listed by the trial registrant

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

Pe - pulmonary embolism Pe - pulmonary thromboembolism

Contacts and locations

Locations

  • Albany Medical Center

    Albany, New York, 12208, United States

  • Allgemeines Krankenhaus AKH Wien

    Vienna, Austria

  • Ascension Genesys Hospital

    Grand Blanc, Michigan, 48439, United States

  • Ascension Providence Hospital

    Madison Heights, Michigan, 48334, United States

  • Ascension Providence Rochester Hospital

    Rochester, Michigan, 48307, United States

  • Ascension Sacred Heart

    Pensacola, Florida, 32504, United States

  • Aurora St. Luke's Medical Center

    Milwaukee, Wisconsin, 53215, United States

  • Baptist Health Lousville

    Louisville, Kentucky, 40207, United States

  • Beaumont Health

    Royal Oak, Michigan, 48073, United States

  • CHU Grenoble

    Grenoble, France

  • CardioVoyage

    Denison, Texas, 75071, United States

  • Cardioangiologisches Centrum Bethanien

    Frankfurt, Germany

  • CentraCare Heart & Vascular Center

    Saint Cloud, Minnesota, 56303, United States

  • Centre Hospitalier Universitaire de Besançon

    Besançon, France

  • Charité Hospital - Campus Virchow-Klinikum

    Berlin, Germany

  • Christiana Care Health Services

    Newark, Delaware, 19713, United States

  • Emory University

    Atlanta, Georgia, 30308, United States

  • European Hospital Georges Pompidou

    Paris, France

  • Gregorio Maranon University Hospital

    Madrid, Spain

  • HCL Hôpital Louis Pradel - Hôpital Cardiologique

    Lyon, France

  • Helios Kliniken Schwerin

    Schwerin, Germany

  • Henry Ford Health System

    Detroit, Michigan, 48202, United States

  • Hopital de la Cavale Blanche - CHU Brest

    Brest, France

  • Hospital Clínico San Carlos

    Madrid, 28040, Spain

  • Indiana University School of Medicine

    Indianapolis, Indiana, 46202, United States

  • Inova Fairfax

    Falls Church, Virginia, 22042, United States

  • Inselspital

    Bern, Switzerland

  • Institut Coeur Poumon - CHU de Lille

    Lille, France

  • Jamaica Hospital

    Queens, New York, 11418, United States

  • Javon Bea Hospital

    Rockford, Illinois, 61103, United States

  • Kantonsspital Sankt Gallen

    Sankt Gallen, Switzerland

  • Lakeland Vascular Institute

    Lakeland, Florida, 33801, United States

  • Lexington Medical Center

    West Columbia, South Carolina, 29169, United States

  • Memorial Hospital Jacksonville

    Jacksonville, Florida, 32216, United States

  • Methodist Healthcare Foundation

    Germantown, Tennessee, 38138, United States

  • Metropolitan Heart and Vascular Institute

    Minneapolis, Minnesota, 55433, United States

  • Missouri Cardiovascular Specialists

    Columbia, Missouri, 65201, United States

  • Mount Sinai

    New York, New York, 10029, United States

  • Mount Sinai Medical Center of Florida

    Miami, Florida, 33140, United States

  • NYU Langone Medical Center

    New York, New York, 10016, United States

  • Northwell Health

    Manhasset, New York, 11030, United States

  • Northwestern University

    Evanston, Illinois, 60208, United States

  • Norton Healthcare

    Louisville, Kentucky, 40205, United States

  • Opelousas General

    Opelousas, Louisiana, 70570, United States

  • Palmetto General Hospital

    Miami, Florida, 33016, United States

  • Pima Heart and Vascular

    Tucson, Arizona, 85741, United States

  • Providence Regional Medical Center Everett

    Everett, Washington, 98201, United States

  • Providence Sacred Heart

    Spokane, Washington, 99204, United States

  • Rush Medical Center

    Chicago, Illinois, 60612, United States

  • SUNY, The University at Buffalo

    Buffalo, New York, 14203, United States

  • Saint Luke's Hospital of Kansas City

    Lee's Summit, Missouri, 64086, United States

  • Sarasota Memorial Hospital

    Sarasota, Florida, 34239, United States

  • Sentara

    Norfolk, Virginia, 23507, United States

  • St. Francis Hospital & Heart Center

    Roslyn, New York, 11576, United States

  • St. Joseph Mercy

    Ypsilanti, Michigan, 48106, United States

  • St. Thomas West

    Nashville, Tennessee, 37205, United States

  • Tallahassee Memorial Hospital

    Tallahassee, Florida, 32308, United States

  • The Royal Free Hospital

    London, United Kingdom

  • The Royal London Hospital, Bart's Health

    London, United Kingdom

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107, United States

  • UAB Division of Cardiovascular Disease

    Birmingham, Alabama, 35294, United States

  • UTMC Knoxville

    Knoxville, Tennessee, 37920, United States

  • UZ Antwerpen

    Antwerp, Belgium

  • UZ Brussel

    Brussels, Belgium

  • Unispital

    Zurich, Switzerland

  • Universitair Medisch Centrum Utrecht

    Utrecht, Netherlands

  • Universitatsklinikum des Saarlandes

    Homburg, Germany

  • University Hospital

    Heidelberg, Germany

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106, United States

  • University of Arizona College of Medicine

    Tucson, Arizona, 85719, United States

  • University of Chicago

    Chicago, Illinois, 60637, United States

  • University of Colorado

    Aurora, Colorado, 80045, United States

  • University of Miami

    Miami, Florida, 33125, United States

  • University of Minnesota

    Minneapolis, Minnesota, 55455, United States

  • University of Missouri, Columbia

    Columbia, Missouri, 65212, United States

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213, United States

  • Valley Health

    Ridgewood, New Jersey, 07450, United States

  • Wake Forest Baptist Medical Center

    Winston-Salem, North Carolina, 27157, United States

  • Westchester Medical Center

    Valhalla, New York, 10595, United States

  • Yale University

    New Haven, Connecticut, 06511, United States

More trials for these conditions

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