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A tiny neck implant could catch Stroke-Causing clots before they reach the brain

NCT ID NCT03892824

Prevention 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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 12, 2026 · Last updated Aug 13, 2026 · Updated 1 time

Summary

This trial is testing a device called the Vine™ Embolic Protection System, which is implanted in the carotid arteries to trap blood clots before they travel to the brain. It is designed for people with atrial fibrillation who are already taking blood thinners but still have a high risk of stroke. Participants receive implants in both carotid arteries and are monitored for safety and any strokes or procedure-related complications.

What this could mean

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

Active substance
Vine™ Embolic Protection System, a device implanted in the carotid arteries to filter blood clots
What this could lead to
If it works, this could offer an extra layer of stroke protection for people with atrial fibrillation who remain at high risk despite taking blood thinners.
What could go wrong
This is an early, small study focused on safety and performance. The implant requires a procedure that carries risks, including bleeding, stroke, or complications needing surgery.

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 100 people

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

Started

Apr 2019

Expected to finish

Oct 2027

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

50 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: * Documented AF * CHA2DS2-VASc score ≥ 4 and history of ischemic stroke (including TIA with positive neuro-imaging) * No contra-indication for patient to receive an OAC, either vitamin K antagonist (VKA) or novel oral anticoagulant (NOAC) for the duration of the study * Age \> 50 years * Maximal (systolic) CCA diameter range: ≥ 4.8mm and ≤ 9.8mm * CCA accessibility: up to 40mm from skin to CCA center, safe approach * Implantation segment free of atherosclerotic disease as determined by ultrasound imaging * Patient is able and willing to provide informed consent Exclusion Criteria: * Evidence of carotid stenosis \> 30% \[CCA, internal carotid artery (ICA), or external carotid artery (ECA)\] * Evidence of carotid dissection * Pre-existing stent(s) in CCA * Female who is pregnant or who is planning to become pregnant during the course of the study * Life expectancy of less than two years * Active systemic infection * Known sensitivity to nickel or titanium metals, or their alloys * Known hereditary or acquired coagulation disorders * Any planned surgical or endovascular treatment within 30 days after the implantation procedure * A co-morbid disease or condition that could confound the neurological and functional evaluations or compromise survival or ability to complete follow-up assessments\* Current use or a recent history of illicit drug(s) use or alcohol abuse (defined as regular or daily consumption of more than four alcoholic drinks per day) * Active participation in another investigational drug or device treatment study * Inability to complete all scheduled follow-up * 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 study * History of intracerebral hemorrhage (ICH) and/or hemorrhagic stroke * Event of stroke/TIA in the past 14 days

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Conditions

The condition(s) this trial relates to.

atrial fibrillation Embolism ischemic stroke stroke disorder prevention target

As listed by the trial registrant

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

Atrial fibrillation Stroke

Contacts and locations

Locations

  • Alfried-Krupp Krankenhaus Rüttenscheid

    Essen, 45131, Germany

  • Cardio Vasculäres Centrum Frankfurt

    Frankfurt, 60389, Germany

  • Cardioangiologisches Centrum Bethanien

    Frankfurt, Germany

  • Carmel

    Haifa, Israel

  • European Interbalkan Medical Center

    Thessaloniki, 57001, Greece

  • General Hospital of Athens "Hippokrateio"

    Athens, 11527, Greece

  • Gottsegen György Hungarian Institute of Cardiology

    Budapest, Hungary

  • Hospital Universitario Ramon y Cajal

    Madrid, Spain

  • Laiko Hospital

    Athens, Greece

  • Na Homolce Hospital

    Prague, Czechia

  • OLV Ziekenhuis

    Aalst, Belgium

  • Poria

    Tiberias, 1520800, Israel

  • Rabin Medical Center (RMC)

    Petah Tikva, Israel

  • Shaari Tzedek

    Jerusalem, 9103102, Israel

  • Szpital Kliniczny Przemienienia Pańskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu, Pracownia Hemodynamiki Serca

    Poznan, Poland

  • University General Hospital of Larisa

    Larissa, Greece

  • ZNA Stuivenberg

    Antwerp, Belgium

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