Atrial FibrillationCAPTURE2NCT03892824
Carotid Artery Implant for Preventing Stroke in Atrial Fibrillation Patients Taking Oral Anticoagulants
A study testing Vine™ Embolic Protection System in people with Atrial Fibrillation and Stroke, run by Javelin Medical at 17 sites in 8 countries.
Trial summary
This study will assess the safety and performance of the Vine™ Embolic Protection System (embolic filtering device) in atrial fibrillation (AF) patients on top of oral anticoagulants (OAC), and remain at high risk for stroke recurrence. All patients will receive bilateral implants in the common carotid arteries Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Atrial Fibrillation, Stroke
- What is being tested?
- Vine™ Embolic Protection System
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 17 sitesin 8 countries
- Study dates
- 15 Apr 2019to 24 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
17 sites in 8 countries.
17 sites in 8 countries
Greece4 sites
General Hospital of Athens "Hippokrateio"
Athens, 11527
Laiko Hospital
Athens
University General Hospital of Larisa
Larissa
European Interbalkan Medical Center
Thessaloniki, 57001
Israel4 sites
Carmel
Haifa
Shaari Tzedek
Jerusalem, 9103102
Rabin Medical Center (RMC)
Petah Tikva
Poria
Tiberias, 1520800
Germany3 sites
Alfried-Krupp Krankenhaus Rüttenscheid
Essen, 45131
Cardio Vasculäres Centrum Frankfurt
Frankfurt, 60389
Cardioangiologisches Centrum Bethanien
Frankfurt
Poland1 site
Szpital Kliniczny Przemienienia Pańskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu, Pracownia Hemodynamiki Serca
Poznan
About this study
Official title: Carotid Artery ImPlant for Trapping UpstReam Emboli (CAPTURE 2) for Preventing Stroke in Atrial Fibrillation Patients Taking Oral Anticoagulants
This study will assess the safety and performance of the Vine™ Embolic Protection System (embolic filtering device) in atrial fibrillation (AF) patients on top of oral anticoagulants (OAC), and remain at high risk for stroke recurrence. All patients will receive bilateral implants in the common carotid arteries
Read the detailed description
The Vine™ filter (Vine™ or implant) is a permanent carotid filter designed for stroke prevention in AF patients taking OAC at high stroke risk (CHA2DS2-VASc ≤ 4 and stroke history). This patient population accounts for ~20% of the entire AF population, which is ~300K/year in the United State and EU. The implant is designed to exclude emboli > 1.4mm in size from reaching the anterior circulation. In AF patients, approximately 80% of strokes are total or partial anterior circulation strokes caused by occlusions of the main branches of the Circle of Willis, mainly M1-2, and rarely A1-2. The diameter of these branches, in the majority of cases, is > 1.5 mm
- Conditions
- Atrial Fibrillation, Stroke
- Being tested
- Vine™ Embolic Protection System
- Keywords
- AF, Stroke, Filter, Emboli, Carotid, OAC
- Medical subject headings
- Atrial Fibrillation, Stroke, Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vine™ Embolic Protection SystemDevice
The system includes the implant and the Vine™ Inserter (inserter) manufactured by Javelin Medical LTD (Israel). The inserter comprises a Motor Unit and a Needle Unit ("Needle Unit") available in two sizes. The system is operable when the Needle Unit is loaded with the implant (labeled "Loaded Needle Unit") and connected to the Motor Unit. A flag indicating the needle orientation is attached to the needle luer. The implant is automatically deployed from the needle upon activation of the operating button.
| Study group | Role | What they receive |
|---|---|---|
| Vine™ Filter + OAC | Experimental | Vine™ Filter in each common carotid artery (CCA) with oral anticoagulant treatment (either vitamin K antagonist (VKA) or novel oral anticoagulant (NOAC)) for the duration of the study Receives: Device: Vine™ Embolic Protection System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants that had Ischemic Stroke and/or Hemorrhagic stroke and/or implantation procedure complications
Major Adverse Events (MAEs) within 30 days of the final index (implantation) procedure, defined as the composite that includes any of the following:
- Any ischemic stroke with ischemic foci confined to the territories of Vine™ implanted arteries
- Hemorrhagic stroke or major hemorrhage while receiving additional antithrombotic therapy required for Vine™ implantation
- Any Vine™ or Vine™ implantation procedure-related complication that requires surgery or endovascular treatment, or results in death or major disability
Measured: 30 days from implantation procedure
Secondary outcomes (8)
Number of participants that had Ischemic Stroke and/or Hemorrhagic stroke and/or Device complications.
- Any ischemic stroke with ischemic foci confined to the territories of Vine™ implanted arteries
- Hemorrhagic stroke or major hemorrhage while receiving additional antithrombotic therapy required for Vine™ implantation
- Any Vine™ or Vine™ implantation procedure-related complication that requires surgery or endovascular treatment, or results in death or major disability
Measured: one and two years from implantation procedure
Number of properly positioned implants
proper implant position in each common carotid artery (CCA)
Measured: 30 days from implantation procedure
Number of participants that had disabling strokes
Disabling stroke
Measured: 30 days, one and two years from implantation procedure
Number of Implantation success
implantation attempt resulting in proper implant position immediately after the procedure without any device/procedure related complication that requires surgery or endovascular treatment for correction, or that results in death or major disability
Measured: immediately after the procedure
Number of properly positioned implants
Proper implant position in each CCA
Measured: one and two years from implantation procedure
Number of observed thrombi on the device
Thrombus on implant detected by ultrasound imaging
Measured: 30 days, one and two years from implantation procedure
Number of death cases
Death
Measured: one and two years from implantation procedure
Number of strokes (any kind)
Total number of strokes
Measured: one and two years from implantation procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2019
- Study start15 Apr 2019
- Primary completion24 Oct 2024
- Study completion24 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Javelin Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Genae
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03892824
- Sponsor's protocol ID
- CL-326
- Acronym
- CAPTURE2
- Status last verified
- Aug 2026
- First submitted
- 21 Mar 2019
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carotid Artery ImPlant for Trapping UpstReam Emboli (CAPTURE 2) for Preventing Stroke in Atrial Fibrillation Patients Taking Oral Anticoagulants
- ClinicalTrials.gov ID
- NCT03892824
- Acronym / sponsor ID
- CAPTURE2 / CL-326
- Conditions
- Atrial Fibrillation, Stroke
- Keywords
- AF, Stroke, Filter, Emboli, Carotid, OAC
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Javelin MedicalIndustry (pharma, biotech, devices)
- Collaborators
- Genae
- Study start
- 15 Apr 2019 (actual)
- Primary completion
- 24 Oct 2024 (actual)
- Study completion
- 24 Oct 2027 (estimated)
- First posted
- 27 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess the safety and performance of the Vine™ Embolic Protection System (embolic filtering device) in atrial fibrillation (AF) patients on top of oral anticoagulants (OAC), and remain at high risk for stroke recurrence. All patients will receive bilateral implants in the common carotid arteries
Detailed description
The Vine™ filter (Vine™ or implant) is a permanent carotid filter designed for stroke prevention in AF patients taking OAC at high stroke risk (CHA2DS2-VASc ≤ 4 and stroke history). This patient population accounts for ~20% of the entire AF population, which is ~300K/year in the United State and EU. The implant is designed to exclude emboli > 1.4mm in size from reaching the anterior circulation. In AF patients, approximately 80% of strokes are total or partial anterior circulation strokes caused by occlusions of the main branches of the Circle of Willis, mainly M1-2, and rarely A1-2. The diameter of these branches, in the majority of cases, is > 1.5 mm
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vine™ Filter + OAC | Experimental | Device: Vine™ Embolic Protection SystemVine™ Filter in each common carotid artery (CCA) with oral anticoagulant treatment (either vitamin K antagonist (VKA) or novel oral anticoagulant (NOAC)) for the duration of the study |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vine™ Embolic Protection SystemThe system includes the implant and the Vine™ Inserter (inserter) manufactured by Javelin Medical LTD (Israel). The inserter comprises a Motor Unit and a Needle Unit ("Needle Unit") available in two sizes. The system is operable when the Needle Unit is loaded with the implant (labeled "Loaded Needle Unit") and connected to the Motor Unit. A flag indicating the needle orientation is attached to the needle luer. The implant is automatically deployed from the needle upon activation of the operating button. | Device | Vine™ Filter + OAC |
Primary outcome
Number of participants that had Ischemic Stroke and/or Hemorrhagic stroke and/or implantation procedure complications
Time frame: 30 days from implantation procedure
Major Adverse Events (MAEs) within 30 days of the final index (implantation) procedure, defined as the composite that includes any of the following: * Any ischemic stroke with ischemic foci confined to the territories of Vine™ implanted arteries * Hemorrhagic stroke or major hemorrhage while receiving additional antithrombotic therapy required for Vine™ implantation * Any Vine™ or Vine™ implantation procedure-related complication that requires surgery or endovascular treatment, or results in death or major disability
8 secondary outcomes
Number of participants that had Ischemic Stroke and/or Hemorrhagic stroke and/or Device complications.
Time frame: one and two years from implantation procedure
Number of properly positioned implants
Time frame: 30 days from implantation procedure
Number of participants that had disabling strokes
Time frame: 30 days, one and two years from implantation procedure
Number of Implantation success
Time frame: immediately after the procedure
Number of properly positioned implants
Time frame: one and two years from implantation procedure
Number of observed thrombi on the device
Time frame: 30 days, one and two years from implantation procedure
Number of death cases
Time frame: one and two years from implantation procedure
Number of strokes (any kind)
Time frame: one and two years from implantation procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
17 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vine™ Embolic Protection System in people with Atrial Fibrillation and Stroke, run by Javelin Medical at 17 sites in 8 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 15 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: under way, not looking for participants, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Greece, Israel, Germany, Belgium, Czechia and 3 more countries. 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?
This study is still under way. Results are not available in the source record yet.
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 participants that had Ischemic Stroke and/or Hemorrhagic stroke and/or implantation procedure complications (time frame: 30 days from implantation procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Aug 2026.