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Could a tiny neck filter stop strokes in heart patients?

NCT ID NCT05723926

Disease control Sponsor: Javelin 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 20, 2026 · Updated 2 times

Summary

This study tests whether implanting small filters in the carotid arteries (the main neck arteries) can prevent repeat strokes in people with atrial fibrillation who have already had a stroke. Participants will receive the filters plus standard blood thinners, or blood thinners alone. The goal is to see if the filters catch blood clots before they reach the brain, reducing the risk of a major stroke.

What this could mean

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

Active substance
Vine Filter (a small mesh device implanted in the carotid artery to catch blood clots)
What this could lead to
If it works, this could offer a new way to prevent disabling strokes in people with atrial fibrillation who are already on blood thinners.
What could go wrong
This is a large trial but still experimental. The implant procedure carries risks like bleeding or damage to the artery, and the filter may not catch all clots. It is not yet proven to be safe or effective.

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 2,000 people

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

Started

Jan 2026

Expected to finish

Oct 2030

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. Documented history of clinical AF 2. History of ischemic (i.e. non-hemorrhagic) stroke including symptoms of stroke resolving within 24 hours with positive neuro-imaging, meeting one of the following criteria: Group 1: Patient was on OAC at time of index stroke, with index stroke occurring \< 6 week from enrollment Group 2: Patient was not on OAC at time of stroke, with index stroke occurring \< 6 weeks from enrollment Group 3: Patient was on OAC at time of index stroke, with index stroke occurring 6 to 52 weeks from enrollment 3. Planned use of a Vitamin K antagonist (VKA) or a direct oral anticoagulant (DOAC) for the duration of the trial 4. Patient able to tolerate single antiplatelet therapy in addition to oral anticoagulation for 6 months, in the opinion of the investigator 5. Bilateral ultrasound or angiogram demonstrating all of the following: 1. Inner common carotid artery diameter range: ≥5.3 mm and ≤8.8 mm 2. Accessibility: up to 40 mm from skin to common carotid artery center 3. Implantation segment free of any atherosclerotic disease 4. Absence of carotid dissection or pre-existing stent(s) in common carotid artery 5. Absence of ≥50% stenosis of the internal carotid arteries as seen on ultrasound or angiography (CTA, MRA or DSA) i. For ultrasound, calculate the percentage of carotid stenosis using the Society of Radiologists in Ultrasound Consensus Criteria for Carotid Stenosis, where ≥50% stenosis is defined by internal carotid artery peak systolic velocity of ≥125 cm/sec, internal/common carotid peak systolic velocity ratio of 2 or more and end diastolic velocity of ≥40 cm/sec, or evidence of near occlusion. ii. For angiography, calculate the percentage of carotid stenosis using the North American Symptomatic Carotid Endarterectomy Trial (NASCET) criteria (\[D - N\]/D x 100, where N is the luminal diameter at the site of maximal narrowing and D is the diameter of normal distal internal carotid artery beyond the bulb where the artery walls are parallel. 6. Provision of informed consent Exclusion Criteria: 1. Contraindication to oral anticoagulation (e.g. history of intracranial hemorrhage, known hereditary or acquired coagulation disorders, or recurrent major bleeding) 2. Contraindication to additional single antiplatelet therapy for 6 months from randomization 3. Previously documented 50% or greater stenosis, or high-risk plaque in the opinion of the investigator, of the common carotid, internal carotid, subclavian, vertebral, or intracranial arteries that has not been treated with a revascularization procedure (i.e. stent or angioplasty) 4. Visualized active (acute/subacute) cervical or intracranial arterial thrombus (i.e. free-floating) on computed tomography (CT), magnetic resonance (MR), or digital subtraction (DS) angiography that is at risk of causing additional stroke/brain injury 5. Previously documented aneurysm of the internal carotid artery or its branches (i.e. ophthalmic, posterior communicating, anterior choroidal, anterior cerebral and middle cerebral arteries) that is 6 mm or greater in diameter. 6. Prior surgery or radiation of the neck at the implantation segment 7. Pre-existing percutaneous left atrial appendage occlusion device that was implanted after most recent ischemic stroke 8. Planned left atrial appendage occlusion procedure 9. Female who is pregnant or non-postmenopausal female who is not willing to use an effective method of birth control during duration of the trial 10. Overt systemic infection 11. Known sensitivity to nickel or titanium metals, or their alloys 12. Active participation in another investigational drug or device treatment trial 13. Any other condition that in the opinion of the investigator may adversely affect the safety of the patient or would limit the patient's ability to complete the trial

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Conditions

The condition(s) this trial relates to.

atrial fibrillation breast implant illness ischemic stroke stroke disorder

As listed by the trial registrant

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

Atrial fibrillation Implant Oral anticoagulation Stroke

How to take part

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

  1. The places running it

    19 sites in 4 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

  • Baptist Memorial Hospital-Memphis

    ACTIVE_NOT_RECRUITING

    Memphis, Tennessee, 38120, United States

  • Boston University Medical Center

    RECRUITING

    Boston, Massachusetts, 02118, United States

  • Erlanger Medical Center

    RECRUITING

    Chattanooga, Tennessee, 37403, United States

  • HCPA

    NOT_YET_RECRUITING

    Porto Alegre, Brazil

  • Hamilton General Hospital

    RECRUITING

    Hamilton, Canada, Canada

  • Hcfmrp-Usp

    NOT_YET_RECRUITING

    Monte Alegre, Brazil

  • Hospital Estadual Central de Vitória

    NOT_YET_RECRUITING

    Vitória, Brazil

  • Hospital São Rafael

    NOT_YET_RECRUITING

    Salvador, Brazil

  • Hospital de Base de Rio Preto

    NOT_YET_RECRUITING

    São José do Rio Preto, Brazil

  • K. Eristavi National Center of Experimental and Clinical Surgery JSC

    RECRUITING

    Tbilisi, Georgia

  • LLC Geo Hospitals Tbilsi Multiprofile Medical Center

    RECRUITING

    Tbilisi, Georgia

  • Mercyhealth Javon Bea Hospital - Riverside

    RECRUITING

    Rockford, Illinois, 61114, United States

  • Methodist University Hospital

    ACTIVE_NOT_RECRUITING

    Memphis, Tennessee, 38104, United States

  • NEURORAD

    NOT_YET_RECRUITING

    São Paulo, Brazil

  • Pineo Medical Ecosystem

    RECRUITING

    Tbilisi, Georgia

  • Tbilisi State Medical University First University Clinic

    RECRUITING

    Tbilisi, Georgia

  • UNIFESP

    NOT_YET_RECRUITING

    São Paulo, Brazil

  • Universidade Fedeal Do Parana

    NOT_YET_RECRUITING

    Curitiba, Brazil

  • University Hospital

    RECRUITING

    London, Ontario, N6A 5A5, Canada

  • Weill Cornell Medical Center

    RECRUITING

    New York, New York, 10065, United States

  • West Georgia Medical Center

    RECRUITING

    Kutaisi, Georgia

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