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New device aims to suck out dangerous blood clots, sparing patients from Long-Term leg damage

NCT ID NCT05701917

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Sep 10, 2026 · Updated 8 times

Summary

This study compares a device that physically removes blood clots from leg veins (ClotTriever) to standard blood-thinning medication alone for people with deep vein thrombosis (DVT). About 300 participants with recent, severe DVT in one leg will be randomly assigned to either treatment. The goal is to see if the device better prevents long-term complications like chronic leg pain and swelling.

What this could mean

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

Active substance
ClotTriever System (a device that mechanically removes blood clots)
What this could lead to
If it works, this could offer a more effective way to treat deep vein thrombosis and reduce the risk of long-term leg pain and swelling (post-thrombotic syndrome).
What could go wrong
This is a relatively early study with 300 participants, so results may not apply to everyone. The device procedure carries risks like bleeding or vessel damage, and it may not prove better than standard blood thinners.

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 300 people

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

Started

Jan 2023

Expected to finish

Jul 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 * Age ≥ 18 years * Proximal lower extremity unilateral DVT involving at least the common femoral, external iliac, or common iliac veins, alone or in combination * Symptom onset within 12 weeks of enrollment in the study * Significant symptoms, as defined by a Villalta score \> 9 * Willing and able to provide informed consent Exclusion Criteria * Bilateral iliofemoral DVT * Prior venous stent in the target venous segment * IVC aplasia/hypoplasia or other congenital anatomic anomalies of the IVC or iliac veins * IVC filter in place at the time of enrollment * Limb-threatening circulatory compromise (e.g., phlegmasia) * Clot in transit including IVC thrombus presenting as extension of \>2cm into the IVC from the CIV * Symptomatic PE with right heart strain where the physician judges that a DVT intervention is inappropriate at this time. * Inability to be a candidate for intervention due to medical or technical reasons based on physician judgement * Severe allergy, hypersensitivity to, or thrombocytopenia from heparin * Severe allergy to iodinated contrast agents that cannot be mitigated * Hemoglobin \< 8.0 g/dL, INR \> 1.7 before warfarin was started, or platelets \< 50,000/µl which cannot be corrected prior to enrollment * Severe renal impairment (estimated GFR \< 30 ml/min) in patients who are not yet on dialysis * Inability to provide therapeutic anticoagulation per Investigator discretion * Uncontrolled severe hypertension on repeated readings (systolic \> 180mmHg or diastolic \> 105mmHg) * Recently (\< 30 days) had DVT interventional procedure * Subject is participating in another study that may interfere with this study * Life expectancy \< 6 months or chronic non-ambulatory status * Known hypercoagulable states that, in the opinion of the Investigator, cannot be medically managed throughout the study period * 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., contraindication to use of ClotTriever per local approved labeling, compromise the well-being or that could prevent, limit, or confound the protocol-specified assessments) * 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.

post-thrombotic syndrome Postthrombotic Syndrome venous thromboembolism Venous Thrombosis

As listed by the trial registrant

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

Deep venous thrombosis Post-thrombotic syndrome Venous thromboembolism

How to take part

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

  1. The places running it

    48 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

  • Allegheny General Health Research Network

    RECRUITING

    Pittsburgh, Pennsylvania, 15212, United States

  • Allegheny St. Vincent Hospital

    RECRUITING

    Erie, Pennsylvania, 16544, United States

  • Aurora St. Luke's Medical Center

    TERMINATED

    Milwaukee, Wisconsin, 53215, United States

  • Baptist Health Research Institute

    RECRUITING

    Jacksonville, Florida, 32207, United States

  • BayCare Health System

    RECRUITING

    Tampa, Florida, 33607, United States

  • Charité - Universitätsmedizin Berlin

    TERMINATED

    Berlin, State of Berlin, 10117, Germany

  • Clements University Hospital (UTSW)

    RECRUITING

    Dallas, Texas, 75390, United States

  • Cleveland Clinic

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Columbia University Irving Medical Center

    RECRUITING

    New York, New York, 10032, United States

  • Community Healthcare System

    TERMINATED

    Munster, Indiana, 46321, United States

  • Cooper University Hospital

    RECRUITING

    Camden, New Jersey, 08103, United States

  • Freeman Hospital Newcastle upon Tyne

    RECRUITING

    Newcastle upon Tyne, United Kingdom

  • GSST London/St Thomas

    RECRUITING

    London, United Kingdom

  • HCA Florida Largo Hospital

    TERMINATED

    Largo, Florida, 33770, United States

  • Helsinki University Hospital

    RECRUITING

    Helsinki, Finland

  • Henry Ford Health

    RECRUITING

    Detroit, Michigan, 48202, United States

  • Holy Name Medical Center

    TERMINATED

    Teaneck, New Jersey, 07666, United States

  • Honor Health

    RECRUITING

    Scottsdale, Arizona, 85258, United States

  • Huntington Health

    RECRUITING

    Pasadena, California, 91105, United States

  • Imperial College

    RECRUITING

    London, United Kingdom

  • Inselspital, Universitätsspital Bern

    RECRUITING

    Bern, Switzerland

  • Kantonsspital Baden

    RECRUITING

    Baden, Switzerland

  • Klinikum Hochsauerland GmbH

    RECRUITING

    Arnsberg, North Rhine-Westphalia, 59759, Germany

  • Lakeland Vascular Institute

    TERMINATED

    Lakeland, Florida, 33805, United States

  • Lexington Medical Center

    TERMINATED

    West Columbia, South Carolina, 29169, United States

  • Luzerner Kantonsspital

    RECRUITING

    Lucerne, Switzerland

  • MVZ CCB Frankfurt und Main-Taunus GbR

    RECRUITING

    Frankfurt am Main, Hesse, 60389, Germany

  • Manatee Memorial Hospital

    TERMINATED

    Bradenton, Florida, 34208, United States

  • McLaren Healthcare

    RECRUITING

    Bay City, Michigan, 48708, United States

  • MedStar Health Research Institution

    RECRUITING

    Washington D.C., District of Columbia, 20010, United States

  • Memorial Health University Medical Center

    TERMINATED

    Savannah, Georgia, 31404, United States

  • Mercy Health - The Heart Institute

    TERMINATED

    Cincinnati, Ohio, 45211, United States

  • Mission Health

    TERMINATED

    Asheville, North Carolina, 28801, United States

  • MyMichigan Medical Center

    RECRUITING

    Midland, Michigan, 48670, United States

  • NYP-Brooklyn Methodist

    RECRUITING

    Brooklyn, New York, 11215, United States

  • NYU Langone Medical Center

    RECRUITING

    New York, New York, 10016, United States

  • Northwell Health

    RECRUITING

    Bay Shore, New York, 11706, United States

  • Oxford - John Radcliffe

    RECRUITING

    Oxford, United Kingdom

  • Pima Heart and Vascular

    RECRUITING

    Tucson, Arizona, 85704, United States

  • Prisma Health Upstate

    TERMINATED

    Greenville, South Carolina, 29615, United States

  • Providence Sacred Heart Med Center

    TERMINATED

    Spokane, Washington, 99204, United States

  • Rhode Island Hospital

    RECRUITING

    Providence, Rhode Island, 02903, United States

  • SUNY, The University at Buffalo

    TERMINATED

    Buffalo, New York, 14203, United States

  • Saint Francis Hospital

    RECRUITING

    Tulsa, Oklahoma, 74136, United States

  • Saint Luke's Hospital of Kansas City

    TERMINATED

    Kansas City, Missouri, 64131, United States

  • Sarasota Memorial Hospital

    RECRUITING

    Sarasota, Florida, 34239, United States

  • Sentara Norfolk General Hospital

    RECRUITING

    Norfolk, Virginia, 23507, United States

  • Spartanburg Medical Center

    RECRUITING

    Spartanburg, South Carolina, 29303, United States

  • St. Elizabeth Edgewood

    TERMINATED

    Edgewood, Kentucky, 41017, United States

  • St. Louis University

    RECRUITING

    St Louis, Missouri, 63104, United States

  • Thomas Jefferson University

    RECRUITING

    Philadelphia, Pennsylvania, 19107, United States

  • UCI Medical Center

    RECRUITING

    Orange, California, 92868, United States

  • University Medical Center of Southern Nevada

    RECRUITING

    Las Vegas, Nevada, 89102, United States

  • University Of Colorado

    RECRUITING

    Denver, Colorado, 80045, United States

  • University of Maryland

    RECRUITING

    Baltimore, Maryland, 21201, United States

  • University of Missouri

    RECRUITING

    Columbia, Missouri, 65212, United States

  • Universität Leipzig

    RECRUITING

    Leipzig, Saxony, 04109, Germany

  • Universitätsklinikum Augsburg

    RECRUITING

    Augsburg, Germany

  • Universitätsklinikum Heidelberg

    RECRUITING

    Heidelberg, Germany

  • Universitätsklinikum Tübingen

    RECRUITING

    Tübingen, Baden-Würtemberg, 72076, Germany

  • Vanderbilt University Medical Center

    RECRUITING

    Nashville, Tennessee, 37232, United States

  • Vascular and Interventional Specialists of Orange County

    RECRUITING

    Orange, California, 92868, United States

  • Vienna General Hospital (AKH Wien)

    RECRUITING

    Vienna, Austria

  • Yale University

    RECRUITING

    New Haven, Connecticut, 06520, United States

More trials for these conditions

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