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Atrial FibrillationCAPTURENCT03571789

Carotid Artery Implant for Trapping Upstream Emboli for Preventing Stroke in Atrial Fibrillation Patients

A study testing Vine™ in people with Atrial Fibrillation, run by Javelin Medical at 4 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Vine™ is a permanent carotid filter designed to provide protection against embolic stroke in people with atrial fibrillation. It is implanted bilaterally in the common carotid arteries from a thin needle under ultrasound guidance. The procedure is performed without general anesthesia and takes minutes. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Atrial Fibrillation
What is being tested?
Vine™
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
4 sitesin 3 countries
Study dates
12 Sep 2017to 28 Nov 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Atrial fibrillation (AF): documented persistent or permanent
  • CHA2DS2-VASc score ≥ 4
  • Age > 50
  • Unsuitable for oral anticoagulation therapy (OAC), defined as contraindicated for OAC, patient refusing OAC, or physician is reluctant to prescribe OAC
  • Maximal (systolic) CCA diameter range: ≥ 5.3mm and ≤ 9.8mm
  • CCA accessibility: up to 60mm from skin to CCA center, safe approach
  • Patient is willing to provide informed consent
  • Patient is willing to complete all scheduled follow-up

Who cannot join

  • Evidence of carotid stenosis > 30% [CCA, internal carotid artery (ICA), or external carotid artery (ECA)
  • Evidence of any atherosclerotic disease in CCA above the clavicles
  • Evidence of carotid dissection
  • Pre-existing stent(s) in CCA
  • Contraindicated or allergic to antiplatelet therapy, or any medication required during the study
  • Recent stroke, TIA, or myocardial infarction (MI) within two months prior to index procedure
Show all 16Show fewer
  • Female who is pregnant or who is planning to become pregnant during the course of the study
  • Life expectancy of less than 1 year
  • Active systemic infection
  • Known sensitivity to nickel or titanium metals, or their alloys
  • Known hereditary or acquired coagulation disorders
  • Any planned surgical or endovascular procedure within 14 days prior to or 30 days after the index 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
  • Any other condition that in the opinion of the investigator may adversely affect the safety of the subject or would limit the subject's ability to complete the study

Trial locations and contacts

4 sites in 3 countries.

4 sites in 3 countries

Belgium2 sites

  • OLV Ziekenhuis

    Aalst

  • ZNA Stuivenberg

    Antwerp

Other trials in Belgium

Czechia1 site

  • Na Homolce Hospital

    Prague

Other trials in Czechia

Netherlands1 site

  • Sint-Antonius ziekenhuis

    Nieuwegein

Other trials in Netherlands

About this study

Vine™ is a permanent carotid filter designed to provide protection against embolic stroke in people with atrial fibrillation. It is implanted bilaterally in the common carotid arteries from a thin needle under ultrasound guidance. The procedure is performed without general anesthesia and takes minutes. The safety, feasibility and tolerability of Vine™ will be evaluated. Patients who are eligible will receive Vine™ and will be followed-up for a year after device implantation.

Read the detailed description

CAPTURE is a prospective, single-arm, multicenter trial, designed to evaluate the safety, feasibility and tolerability of the Vine™ permanent carotid filter. The trial will enroll up to 30 patients, and will be conducted in up to five sites worldwide. All enrolled patients will be invited for non-invasive follow-up tests and clinical evaluations according to the study protocol.

Being tested
Vine™
Keywords
AF
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vine™Device

    The Vine™ is made of a super-elastic nitinol wire comprises a helix that resides within the CCA lumen and a linear stem that traverses the CCA wall. The helix includes three segments: supporting coils, filter, and leading coils.

    The device is available in sizes of 6.0mm - 10.0mm (in 0.5mm intervals) to accommodate individual CCA diameters

Study groups in NCT03571789
Study groupRoleWhat they receive
Vine™ implantation bilaterally in the common carotid arteriesExperimentalVine™ is a permanent carotid filter made from a single nitinol wire. It is configured to capture emboli exceeding 1.2mm in size, which originate in the heart and large arteries below the neck. Vine™ has a helical structure, with leading and supporting coils interposed by a filter section.
Receives: Device: Vine™

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of patients with no incidence of device and/or procedure related Major Adverse Events (MAEs)

    Major Adverse Events (MAEs) are defined as:

    • Death
    • Major and minor strokes
    • Major bleeding
    • Common carotid artery (CCA) stenosis > 70%
    • Vine™ migration
    • CCA thrombus
    • Any complications in the CCA requiring endovascular treatment or surgery

    Measured: 30 days from implantation procedure

  2. Number of patients with Procedure Success

    Procedure Success is defined as Proper Vine™ Position in each CCA

    Proper Vine™ Position is defined as:

    • Supporting coil in contact with artery walls
    • No migration
    • No fracture
    • No Vine™ coils or portions thereof visible outside the arterial lumen
    • No entangled or overlapping coils

    Measured: 30 days from implantation procedure

Secondary outcomes (3)

  1. Number of patients with no incidence of device and/or procedure related Major Adverse Events (MAEs)

    Death

    • Major and minor strokes
    • Major bleeding
    • Common carotid artery (CCA) stenosis > 70%
    • Vine™ migration
    • CCA thrombus
    • Any complications in the CCA requiring endovascular treatment or surgery

    Measured: within 3, 6, months,1, 2, 3, 4 and 5 years of implantation procedure

  2. Number of Successful Delivery and Deployment Attempts

    Successful Delivery and Deployment Attempts is defined as Proper Vine™ Position

    Measured: within 4 hours of implantation procedure

  3. Number of patients with properly positioned Vine™ in each CCA

    Proper implant position

    Measured: within 3, 6, months,1, 2, 3, 4 and 5 years of implantation procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jun 2018
  2. Study start12 Sep 2017
  3. Primary completion13 Dec 2018
  4. Study completion28 Nov 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Model description
Multicenter, prospective, non-randomized, open-label, first-in-human (FIH) study
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03571789
Sponsor's protocol ID
CL-150
Acronym
CAPTURE
Status last verified
Sep 2023
First submitted
30 May 2018
Last updated
20 Feb 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Reddy VY, Neuzil P, de Potter T, van der Heyden J, Tromp SC, Rensing B, Jiresova E, Dujka L, Lekesova V. Permanent Percutaneous Carotid Artery Filter to Prevent Stroke in Atrial Fibrillation Patients: The CAPTURE Trial. J Am Coll Cardiol. 2019 Aug 20;74(7):829-839. doi: 10.1016/j.jacc.2019.04.035. Epub 2019 May 11.

    PubMed 31085320

Questions about this trial

What is this clinical trial studying?

A study testing Vine™ in people with Atrial Fibrillation, run by Javelin Medical at 4 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Belgium, Czechia, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of patients with no incidence of device and/or procedure related Major Adverse Events (MAEs) (time frame: 30 days from implantation procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03571789, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2025.

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