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New device aims to clear leg artery clots without major surgery

NCT ID NCT07135895

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 07, 2026 · Updated 3 times

Summary

This study tests a device called the Artix Thrombectomy System to remove blood clots from leg arteries in people with sudden blockages. About 250 adults with symptoms lasting up to 14 days will be enrolled. The goal is to see if the device can safely restore blood flow and prevent complications like amputation.

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 250 people

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

Started

Jan 2026

Expected to finish

Oct 2029

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 * Acute symptom duration ≤ 14 days * Lower limb arterial occlusion below inguinal ligament * Target lesion in native vessel * Target vessel size between 3 mm and 8 mm by visual estimation * Rutherford category I, IIa, or IIb * Informed consent is obtained from either patient or legally authorized representative (LAR) per Institutional Review Board/Ethics Committee requirements Exclusion Criteria: * Life expectancy \< 6 months * Prior major amputation in the target limb * Prior minor amputation in the target limb that is not completely healed or cannot bear weight * Non-thrombotic occlusion secondary to dissection, vasculitis, or target vessel trauma * Treatment of the index event in the target vessel with any other endovascular thrombectomy/aspiration or open surgical method prior to Artix procedure * Part of a vulnerable population (e.g., currently pregnant, breastfeeding or incarcerated) per local definitions * Known sensitivity to radiographic contrast agents that, in the Investigator's opinion, cannot be adequately pre-treated * Unable to tolerate antiplatelet therapy * Inability to anticoagulate the patient with heparin, enoxaparin or other parenteral antithrombin, or known to have uncorrected bleeding disorders (e.g., gastro-intestinal ulcer, menorrhagia, liver failure, heparin-induced thrombocytopenia (HIT)) * 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 Artix per local approved labeling, compromise the well-being or that could prevent, limit, or confound the protocol-specified assessments) * Current participation in another drug or device study that, in the investigator's opinion, would interfere with participation in this study

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Conditions

The condition(s) this trial relates to.

arterial occlusion

As listed by the trial registrant

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

Acute lower limb arterial occlusion

How to take part

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

  1. The places running it

    20 sites. 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 Hospital

    RECRUITING

    Pittsburgh, Pennsylvania, 15212, United States

  • Ascension Sacred Heart Pensacola

    RECRUITING

    Pensacola, Florida, 32504, United States

  • Ascension St. John Jane Phillips Medical Center

    RECRUITING

    Bartlesville, Oklahoma, 74006, United States

  • Aultman Hospital

    RECRUITING

    Canton, Ohio, 44710, United States

  • Bellin Health

    RECRUITING

    Green Bay, Wisconsin, 54301, United States

  • California Pacific Medical Center Van Ness/Sutter Health

    RECRUITING

    San Francisco, California, 94109, United States

  • Cooper University Hospital

    RECRUITING

    Camden, New Jersey, 08103, United States

  • Grand Strand Medical Center

    RECRUITING

    Myrtle Beach, South Carolina, 29572, United States

  • Mass General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • MedStar Washington Hospital Center

    RECRUITING

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

  • Mission Memorial Hospital

    RECRUITING

    Asheville, North Carolina, 28801, United States

  • MyMichigan Health

    RECRUITING

    Midland, Michigan, 48670, United States

  • NYP-Brooklyn Methodist Hospital

    RECRUITING

    Brooklyn, New York, 11215, United States

  • Saint Francis Hospital

    RECRUITING

    Tulsa, Oklahoma, 74136, United States

  • Spartanburg Regional Health System

    RECRUITING

    Spartanburg, South Carolina, 29303, United States

  • Terrebonne General Hospital/Cardiovascular Institute of the South

    RECRUITING

    Houma, Louisiana, 70360, United States

  • The Christ Hospital

    RECRUITING

    Cincinnati, Ohio, 45219, United States

  • TriStar Centennial Medical Center

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Vassar Brothers Medical Center/Nuvance Health

    RECRUITING

    Poughkeepsie, New York, 12601, United States

  • Yale University

    RECRUITING

    New Haven, Connecticut, 06510, United States