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New device aims to unclog stents in leg veins

NCT ID NCT06394739

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 17, 2026 · Updated 6 times

Summary

This study tests a new device called the RevCore Thrombectomy Catheter to treat blocked stents in the leg veins. About 100 adults with stents that have been in place for at least 6 weeks will be enrolled. The device is inserted into the vein to remove the blockage and restore blood flow. The main goal is to see if the device can successfully reopen the stent.

What this could mean

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

Active substance
RevCore Thrombectomy Catheter (device)
What this could lead to
If successful, this device could offer a new way to quickly reopen blocked stents in leg veins, potentially reducing complications like pain and swelling.
What could go wrong
This is an early study with only 100 people, so results may not apply to everyone. The device may not work for all types of stent blockages, and there are risks like vessel damage or incomplete clearing.

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

About 100 people

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

Started

Sep 2024

Expected to finish

Apr 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.

Who is studied

Up to 100 subjects with in-stent thrombosis will be enrolled. All subjects who sign informed consent and who meet all of the inclusion criteria and none of the exclusion criteria will be eligible to participate in the study.

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 ≥ 18 years 2. Patients with stent age \> 6 weeks 3. Location of thrombosed stents in proximal lower extremity deep vein segments including at least common femoral, external iliac, or common iliac vein 4. RevCore Thrombectomy Catheter must enter vasculature 5. Willing and able to provide informed consent Exclusion Criteria: 1. Exposed stents with broken struts, significantly deformed struts, struts protruding into the vessel 2. Stents not wall apposed 3. Stents compressed to \<10mm 4. Bilateral in-stent thrombosis 5. Congenital anatomic anomalies of the iliac veins 6. Allergy, hypersensitivity, or thrombocytopenia from heparin or iodinated contrast agents, except for mild to moderate contrast allergies for which pretreatment can be used 7. Any contraindication to anticoagulants or antiplatelets that, in the opinion of the Investigator, cannot be medically managed throughout the study period 8. Chronic non-ambulatory status 9. Known hypercoagulable states (e.g. antiphospholipid syndrome) that, in the opinion of the Investigator, cannot be medically managed throughout the study period 10. Inability to secure venous access 11. Subject has any condition for which, in the opinion of the Investigator, participation would not be in the best interest of the subject 12. Current participation in another investigational drug or device treatment study

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Conditions

The condition(s) this trial relates to.

coronary thrombosis

As listed by the trial registrant

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

In-stent thrombosis

How to take part

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

  1. The places running it

    15 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 Health Network Research Institute

    RECRUITING

    Pittsburgh, Pennsylvania, 15212, United States

  • Baylor Scott & White Research Institute

    RECRUITING

    Plano, Texas, 75093, United States

  • El Paso Cardiology Associates

    RECRUITING

    El Paso, Texas, 79902, United States

  • Medstar Health Research Institute

    RECRUITING

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

  • Mission Health

    RECRUITING

    Asheville, North Carolina, 28801, United States

  • New York University- Langone

    RECRUITING

    New York, New York, 10016, United States

  • Ohio State University

    RECRUITING

    Columbus, Ohio, 23210, United States

  • Sentara

    RECRUITING

    Norfolk, Virginia, 23507, United States

  • Spartanburg Medical Center

    RECRUITING

    Spartanburg, South Carolina, 29303, United States

  • St. Luke's Hospital Boise

    RECRUITING

    Boise, Idaho, 83712, United States

  • Thomas Jefferson University

    WITHDRAWN

    Philadelphia, Pennsylvania, 19107, United States

  • UH Cleveland Medical Center

    RECRUITING

    Cleveland, Ohio, 44106, United States

  • University of Maryland

    ACTIVE_NOT_RECRUITING

    Baltimore, Maryland, 21201, United States

  • University of Pennsylvania

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • University of Washington

    RECRUITING

    Seattle, Washington, 98133, United States

  • West Virginia University- Ruby Memorial

    RECRUITING

    Morgantown, West Virginia, 26506, United States

  • Yale University

    RECRUITING

    New Haven, Connecticut, 06511, United States