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New device aims to improve survival and reduce hospital stays for lung clot patients

NCT ID NCT06055920

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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 11, 2026 · Updated 7 times

Summary

This study compares a device called FlowTriever (used with blood thinners) to blood thinners alone for people with intermediate-risk pulmonary embolism (blood clots in the lungs). About 1,200 adults with clots in major lung arteries and signs of heart strain will be randomly assigned to one of two groups. The goal is to see if the device reduces death, worsening symptoms, hospital readmission, and shortness of breath within 30 days.

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 1,200 people

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

Started

Nov 2023

Expected to finish

Oct 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 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, as confirmed by CTPA, pulmonary angiography, or other imaging modality 3. RV dysfunction, as defined as one or more of the following: RV/LV ratio ≥ 0.9 or RV dilation or hypokinesis 4. At least two additional risk factors, identified by at least one measure in two separate categories noted below: a. Hemodynamic: i. SBP 90-100mmHg ii. Resting heart rate \> 100 bpm b. Biomarker: i. Elevated\* cardiac troponin (troponin I or troponin T, conventional or high sensitivity) ii. Elevated\* BNP or NT-proBNP iii. Elevated venous lactate ≥2 mmol/L \* Elevated, meaning at or above the upper limit of normal, per local standards for the assay used c. Respiratory: i. O2 saturation \< 90% on room air ii. Supplemental O2 requirement ≥ 4 L/min iii. Respiratory rate ≥ 20 breaths/min iv. mMRC score \> 0 5. Symptom onset within 14 days of confirmed PE diagnosis 6. Willing and able to provide informed consent Exclusion Criteria: 1. Unable to be anticoagulated with heparin, enoxaparin or other parenteral antithrombin 2. Presentation with hemodynamic instability\* that meets the high-risk PE definition in the 2019 ESC Guidelines1, including ANY of the following 1. Cardiac arrest OR 2. Systolic BP \< 90 mmHg or vasopressors required to achieve a BP ≥ 90 mmHg despite adequate filling status, AND end-organ hypoperfusion OR 3. 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 \* Patients who are stable at time of screening or randomization (i.e., SBP ≥ 90 mmHg and adequate organ perfusion without catecholamine or vasopressor infusion) may be included despite initial presentation including temporary, low-dose catecholamines or vasopressors, or temporary fluid resuscitation. 3. Known sensitivity to radiographic contrast agents that, in the Investigator's opinion, cannot be adequately pre-treated 4. 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) 5. End stage medical condition with life expectancy \< 3 months, as determined by the Investigator 6. Current participation in another drug or device study that, in the investigator's opinion, would interfere with participation in this study 7. Current or history of chronic thromboembolic pulmonary hypertension (CTEPH) or chronic thromboembolic disease (CTED) diagnosis, per 2019 ESC Guidelines1 8. If objective testing was performed\*, estimated RV systolic pressure \> 70 mmHg on standard of care echocardiography \* If clinical suspicion of acute-on-chronic PE, chronic obstruction, or chronic thromboembolism, echocardiographic estimated RVSP must be confirmed ≤70 mmHg to meet eligibility. Pressure assessment not required if Investigator attests to absence of such clinical suspicion 9. Administration of advanced therapies (thrombolytic bolus, thrombolytic drip/infusion, catheter-directed thrombolytic therapy, mechanical thrombectomy, or ECMO) for the index PE event within 30 days prior to enrollment 10. Ventricular arrhythmias refractory to treatment at the time of enrollment 11. Known to have heparin-induced thrombocytopenia (HIT) 12. 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 System per local approved labeling 13. Subject is currently pregnant 14. Subject has previously completed or withdrawn from this study

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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

  • AHN Saint Vincent Hospital

    Erie, Pennsylvania, 16505, United States

  • AP-HM Hopital La Timone

    Marseille, France

  • Aarhus University Hospital

    Aarhus, 8200, Denmark

  • AdventHealth Orlando

    Orlando, Florida, 32803, United States

  • Allegheny Health Network Research Institute

    Pittsburgh, Pennsylvania, 15212, United States

  • Ascension Saint Thomas Hospital

    Nashville, Tennessee, 37203, United States

  • Aurora Saint Luke's Medical Center

    Milwaukee, Wisconsin, 53215, United States

  • Baylor Scott & White - Temple

    Temple, Texas, 76508, United States

  • Brookwood Medical Center

    Birmingham, Alabama, 35243, United States

  • CCB Frankfurt

    Frankfurt, Germany

  • CHU Lille

    Lille, France

  • Charité Campus Virchow Clinic - Klinik fuer Radiologie

    Berlin, Germany

  • Charleston Area Medical Center

    Charleston, West Virginia, 25304, United States

  • Elisabeth Hospital GmbH

    Essen, Germany

  • Emory University

    Atlanta, Georgia, 30322, United States

  • HCA FL Largo Medical Center

    Largo, Florida, 33770, United States

  • HCA Tristar

    Brentwood, Tennessee, 37027, United States

  • HerzZentrum Dresden Universitaetsklinik

    Dresden, Germany

  • Hopital Clinico Universitario San Carlos

    Madrid, Spain

  • Huntington Memorial Hospital

    Pasadena, California, 91105, United States

  • Hôpital Louis Pradel

    Lyon, France

  • Hôpital Nord Marseille

    Marseille, France

  • Inova Fairfax

    Falls Church, Virginia, 22042, United States

  • Klinikum rechts der Isar (TUM)

    Munich, Germany

  • Ludwig Maximilians-University

    Munich, Germany

  • Luzerner Kantonsspital

    Lucerne, Switzerland

  • McLaren Greater Lansing

    Lansing, Michigan, 48910, United States

  • Mercy Hospital Springfield

    Springfield, Missouri, 65804, United States

  • Methodist Main Hospital

    San Antonio, Texas, 78229, United States

  • Montefiore Medical Center

    The Bronx, New York, 10467, United States

  • Nebraska Medical Center

    Omaha, Nebraska, 68105, United States

  • Northwell Health

    New York, New York, 10075, United States

  • Northwestern University

    Chicago, Illinois, 60611, United States

  • Ohio State University - Wexner Medical Center

    Columbus, Ohio, 43210, United States

  • Onze Lieve Vrouwziekenhuis

    Aalst, Belgium

  • Parkland Hospital

    Dallas, Texas, 75235, United States

  • Royal Columbian Hospital

    New Westminster, British Columbia, V3L 3W7, Canada

  • SUNY, The University of Buffalo/Gates Vascular

    Buffalo, New York, 14203, United States

  • Saint Luke's Hospital of Kansas City

    Kansas City, Missouri, 64111, United States

  • Schwarzwald-Baar-Klinikum

    Villingen-Schwenningen, Germany

  • St. Luke's University Hospital

    Bethlehem, Pennsylvania, 18015, United States

  • Stony Brook University Hospital

    Stony Brook, New York, 11794, United States

  • Surrey Memorial Hospital

    Surrey, British Columbia, V3V 1Z2, Canada

  • Texas Health Harris Methodist Hospital

    Fort Worth, Texas, 76104, United States

  • The Cleveland Clinic Foundation

    Cleveland, Ohio, 44195, United States

  • The University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19144, United States

  • UAB Division of Cardiovascular Disease

    Birmingham, Alabama, 35205, United States

  • UPMC Hamot

    Erie, Pennsylvania, 16507, United States

  • UPMC Harrisburg

    Harrisburg, Pennsylvania, 17101, United States

  • UPMC Heart and Vascular Institute

    Pittsburgh, Pennsylvania, 15213, United States

  • UTMC Knoxville

    Knoxville, Tennessee, 37920, United States

  • Unfall Krankenhaus Berlin

    Berlin, Germany

  • Universitaetsklinikum Dὒsseldorf

    Düsseldorf, Germany

  • Universitaetsklinikum Essen

    Essen, Germany

  • Universitaetsklinikum Hamburg Eppendorf

    Hamburg, Germany

  • Universitaetsspital Basel

    Basel, Switzerland

  • University Hospital - Heidelberg

    Heidelberg, Germany

  • University Hospital Augsburg

    Augsburg, Germany

  • University Hospital Cologne

    Cologne, Germany

  • University Hospital Regensburg

    Regensburg, Germany

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45219, United States

  • University of Colorado, Denver

    Aurora, Colorado, 80045, United States

  • University of Rochester Medical Center

    Rochester, New York, 14642, United States

  • Universitäts-Herzzentrum Bad Krozingen

    Bad Krozingen, Germany

  • Universitätsspital Bern

    Bern, Switzerland

  • Vancouver General Hospital

    Vancouver, British Columbia, V5Z 1M9, Canada

  • Virtua Health

    Camden, New Jersey, 08103, United States

  • Wellspan York Hospital

    York, Pennsylvania, 17403, United States

  • West Virginia University Ruby Memorial Hospital

    Morgantown, West Virginia, 26506, United States

  • Westpfalz Klinikum

    Kaiserslautern, Germany

  • Yale University

    New Haven, Connecticut, 06520, United States

More trials for these conditions

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