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New device aims to catch clots during DVT procedure, prevent lung damage

NCT ID NCT06495996

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Sep 11, 2026 · Updated 7 times

Summary

This study tested a special sheath (the Protrieve Sheath) placed in a large vein to catch any blood clots that might break loose during a procedure to remove deep vein clots (DVT). The goal was to prevent those clots from reaching the lungs and causing a pulmonary embolism. The study included 66 people at high risk for such complications. Researchers measured how well the device captured clots and whether it caused any serious side effects.

What this could mean

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

Active substance
Protrieve Sheath (a device that catches blood clots during a procedure to remove deep vein clots)
What this could lead to
If it works, this device could reduce the risk of a blood clot traveling to the lungs during DVT treatment, making the procedure safer.
What could go wrong
This was a small, single-arm study with no comparison group, so results may not be definitive. The device itself carries risks like bleeding or damage to blood vessels.

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

66 people

The number who actually took part.

Started

Mar 2025

Finished

Nov 2025

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 ≥ 18 years 2. Planned intervention for DVT presenting with one or more of the following characteristics indicative of elevated risk for PE: 1. Bilateral iliofemoral DVT 2. Clot extending into or located in the IVC 3. In-stent thrombosis 4. Presence of thrombosed IVC filter 5. Other features that the investigator deems put the subject at elevated risk for thromboembolism 3. Willing and able to provide informed consent Exclusion Criteria: 1. Current symptomatic PE 2. Known anatomic inability to place Protrieve device via jugular vein access site 3. Presence of clot extending to the IVC-Right Atrial junction or in the SVC 4. Subject is pregnant 5. Severe allergy to iodinated contrast agents that cannot be mitigated 6. INR \> 1.7 if not currently on anticoagulation therapy, platelets \< 50,000/μl which cannot be corrected prior to enrollment, or Hemoglobin \< 8.0 g/dL 7. Severe renal impairment in patients who are not yet on dialysis that in the Investigator's discretion would pose risk to the patient with the use of marketed contrast agents 8. Subject is participating in another study that may interfere with this study 9. Subject has any condition for which, in the opinion of the Investigator, participation would not be in the best interest of the subject 10. Subject has previously completed or withdrawn from this study 11. Limb-threatening circulatory compromise (e.g., phlegmasia) 12. Uncontrolled severe hypertension on repeated readings (systolic \> 180mmHg or diastolic \> 105mmHg) 13. Severe allergy, hypersensitivity to, or thrombocytopenia from heparin 14. Inability to provide therapeutic anticoagulation per Investigator discretion 15. Known hypercoagulable states that, in the opinion of the Investigator, cannot be medically managed throughout the study period 16. Inability to be a candidate for intervention due to medical or technical reasons based on physician judgement

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Conditions

The condition(s) this trial relates to.

venous thromboembolism Venous Thrombosis pulmonary embolism prevention target

As listed by the trial registrant

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

Deep venous thrombosis Venous thromboembolism

Contacts and locations

Locations

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212, United States

  • Baptist Health South Florida

    Miami, Florida, 33176, United States

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215, United States

  • Englewood Hospital

    Englewood, New Jersey, 07631, United States

  • Hoag Hospital

    Newport Beach, California, 92663, United States

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • IU Health Methodist Hospital

    Indianapolis, Indiana, 46204, United States

  • MedStar Union Memorial Hospital

    Baltimore, Maryland, 21218, United States

  • NYU Langone Medical Center

    New York, New York, 10016, United States

  • University Medical Center Southern Nevada

    Las Vegas, Nevada, 89102, United States

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • University of Texas Medical Branch

    Galveston, Texas, 77555, United States

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37203, United States

  • West Virginia University Hospital

    Morgantown, West Virginia, 26506, United States

  • Yale University

    New Haven, Connecticut, 06510, United States

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