Atrial FibrillationINTERCEPTNCT05723926
Carotid Implants for PreveNtion of STrokE ReCurrEnce From Large Vessel Occlusion in Atrial Fibrillation Patients Treated With Oral Anticoagulation
A study testing Vine Filter in people with Atrial Fibrillation and Oral Anticoagulation, run by Javelin Medical at 21 sites in 4 countries.
Trial summary
Patients with atrial fibrillation (AF) who have had a prior stroke are at very high risk of recurrent ischemic stroke. About 40% of these strokes are due to large emboli which result in large cerebral vessel occlusion (LVO). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Oral Anticoagulation, Stroke
- What is being tested?
- Vine Filter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 21 sitesin 4 countries
- Study dates
- 9 Jan 2026to 20 Oct 2030
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented history of clinical AF
- 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
- Planned use of a Vitamin K antagonist (VKA) or a direct oral anticoagulant (DOAC) for the duration of the trial
- Patient able to tolerate single antiplatelet therapy in addition to oral anticoagulation for 6 months, in the opinion of the investigator
- Bilateral ultrasound or angiogram demonstrating all of the following:
Show all 14Show fewer
- Inner common carotid artery diameter range: ≥5.3 mm and ≤8.8 mm
- Accessibility: up to 40 mm from skin to common carotid artery center
- Implantation segment free of any atherosclerotic disease
- Absence of carotid dissection or pre-existing stent(s) in common carotid artery
- Absence of ≥50% stenosis of the internal carotid arteries as seen on ultrasound or angiography (CTA, MRA or DSA)
- 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.
- 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.
- Provision of informed consent
Who cannot join
- Contraindication to oral anticoagulation (e.g. history of intracranial hemorrhage, known hereditary or acquired coagulation disorders, or recurrent major bleeding)
- Contraindication to additional single antiplatelet therapy for 6 months from randomization
- 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)
- 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
- 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.
- Prior surgery or radiation of the neck at the implantation segment
Show all 13Show fewer
- Pre-existing percutaneous left atrial appendage occlusion device that was implanted after most recent ischemic stroke
- Planned left atrial appendage occlusion procedure
- 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
- Overt systemic infection
- Known sensitivity to nickel or titanium metals, or their alloys
- Active participation in another investigational drug or device treatment trial
- 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
Trial locations and contacts
21 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
Jessica Tyrwhitt contact
21 sites in 4 countries
Brazil8 sites, 8 recruiting
- Not yet recruiting
Universidade Fedeal Do Parana
Curitiba
Viviane Flumignan Zetola, Dr
- Not yet recruiting
Hcfmrp-Usp
Monte Alegre
Daniel Octávio Pontes, dgabud@gmail.com
- Not yet recruiting
HCPA
Porto Alegre
Porto Alegre Martins, Dr, sheila.ouriques.martins@gmail.com
- Not yet recruiting
Hospital São Rafael
Salvador
Bruno Pedreira, Dr, brunopedreira@hotmail.com
- Not yet recruiting
Hospital de Base de Rio Preto
São José do Rio Preto
Raquel Hidalgo, Dr, draquelhidalgo@gmail.com
- Not yet recruiting
NEURORAD
São Paulo
Rogerio Darwich, Dr, dr.rogeriodarwich@gmail.com
- Not yet recruiting
UNIFESP
São Paulo
Gisele Sampaio Silva, Dr, giselesampaio@hotmail.com
- Not yet recruiting
Hospital Estadual Central de Vitória
Vitória
Leandro assis Barbosa, Dr, leandro.assisbarbosa@gmail.com
United States6 sites, 4 recruiting
- Recruiting
Boston University Medical Center
Boston, Massachusetts, 02118
Thanh Nguyen, Dr, 8572251891, thanh.nguyen@bmc.org
- Recruiting
Erlanger Medical Center
Chattanooga, Tennessee, 37403
Cleopatra Thurman, Dr, 423-778-3900, Cleopatra.Thurman@erlanger.org
Cleopatra Thurman, Dr
- Active, not recruiting
Methodist University Hospital
Memphis, Tennessee, 38104
- Active, not recruiting
Baptist Memorial Hospital-Memphis
Memphis, Tennessee, 38120
- Recruiting
Weill Cornell Medical Center
New York, New York, 10065
Hooman Kamel, Dr, 4158457543, hok9010@med.cornell.edu
Hooman Kamel, Dr
- Recruiting
Mercyhealth Javon Bea Hospital - Riverside
Rockford, Illinois, 61114
Vibhav Bansal, Dr, 8159715000, vbansal@mhemail.org
Vibhav Bansal, Dr
Georgia5 sites, 5 recruiting
- Recruiting
West Georgia Medical Center
Kutaisi
Tamar Janelidze, Dr, 995595711300, tjanelidze@vian.health
- Recruiting
K. Eristavi National Center of Experimental and Clinical Surgery JSC
Tbilisi
Tatuli Gubeladze, Dr, +995 599 008 075 ext. +995 599 008 0, tatuli.gubeladze2022@gmail.com
- Recruiting
LLC Geo Hospitals Tbilsi Multiprofile Medical Center
Tbilisi
Natia Zarkua, Dr, +995577551513, Natiazarkua555@gmail.com
- Recruiting
Pineo Medical Ecosystem
Tbilisi
Alexander Tsiskarizde, Dr, 995 599 556479, Alexandaer.tsiskaridze@tsu.ge
- Recruiting
Tbilisi State Medical University First University Clinic
Tbilisi
Maia Beridze, Prof, +995 568 349602, m.beridze@tsmu.edu
Canada2 sites, 2 recruiting
- Recruiting
Hamilton General Hospital
Hamilton, Canada
Aristeidis Katsanos, MD, 905-521-2100, aristeidis.katsanos@phri.ca
Aristeidis Katsanos, MD
- Recruiting
University Hospital
London, Ontario, N6A 5A5
Luciano Sposato, Dr, 519-663-3110, Luciano.Sposato@LHSC.on.ca
Luciano Sposato, Dr
About this study
Patients with atrial fibrillation (AF) who have had a prior stroke are at very high risk of recurrent ischemic stroke. About 40% of these strokes are due to large emboli which result in large cerebral vessel occlusion (LVO). This randomized control trial aims to address this unmet need by testing whether use of bilateral carotid filter implants in addition to OAC will reduce the risk of stroke in AF patients with recent (e.g. within 12 months) ischemic stroke vs. only OAC.
Read the detailed description
Patients with atrial fibrillation (AF) who have had a prior stroke are at very high risk of recurrent ischemic stroke. Oral anticoagulation (OAC) is very effective for stroke reduction, but despite this treatment, AF patients with stroke in the past year still have a very high risk of recurrent stroke which is often disabling; estimated to be between 3 and 7% per year. About 40% of these strokes are due to large emboli which result in large cerebral vessel occlusion (LVO). Thus, there is a well-documented unmet medical need to improve stroke reduction therapy for AF patients with prior ischemic stroke. This study aims to address this unmet need by testing whether use of bilateral carotid filter implants in addition to OAC will reduce the risk of stroke in AF patients with recent (e.g. within 12 months) ischemic stroke. These filters have been shown, in vitro, to capture all emboli ≥1.4 mm in length or diameter and additionally to capture some emboli of smaller diameter. Once placed bilaterally in the common carotid arteries, they are expected to prevent most emboli ≥1.4 mm in length or diameter and potentially some smaller ones from reaching the anterior cerebral circulation. Although the posterior circulation will not be protected, the majority of all large ischemic strokes in patients with AF occur in the anterior circulation (about 90%). It is hypothesized therefore that bilateral carotid implants will greatly reduce embolic strokes due to LVO (60% reduction) and will have an important but smaller effect on embolic strokes due to smaller emboli which cause non-LVO occlusion (10% reduction). LVO-associated strokes are more often large and disabling compared to non-LVO strokes. The primary goal of the study is to show that bilateral carotid implants reduce strokes due to LVO and that there is also a reduction in total ischemic stroke, both in comparison to a control arm (treatment with OAC only). The study will also evaluate the safety of the intervention.
- Conditions
- Atrial Fibrillation, Oral Anticoagulation, Stroke, Implant
- Being tested
- Vine Filter
- Keywords
- Filter, Ischemic stroke, NOAC, LVO
- Medical subject headings
- Atrial Fibrillation, Stroke, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vine FilterDevice
Also called Vine Embolic Protection System
The Vine filters are designed to be implanted in the common carotid arteries in order to capture emboli coming from the heart or great vessels, before they can enter the anterior intracranial circulation. The filter is deployed percutaneously using a 22G needle under ultrasound guidance.
| Study group | Role | What they receive |
|---|---|---|
| Vine Filter and oral anticoagulant | Experimental | Participants randomized to the intervention will undergo implantation of bilateral carotid filters and OAC therapy. In addition, participants will receive additional single antiplatelet therapy with OAC for 6 months. Receives: Device: Vine Filter |
| Usual Care (oral anticoagulant only) | No intervention | Participants randomized to control will not receive carotid filter implants but will receive usual care including OAC, throughout the course of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Large vessel occlusion strokes (efficacy)
assessed by MRI/CTA
Measured: 44 months
Serious device or procedure related complications (safety)
Defined as any carotid filter or procedure related complication (excluding ischemic stroke) that results in death) or major disability, or that requires endovascular stenting or surgical correction.
Measured: 44 months
ISTH (International Society on Thrombosis and Haemostasis) major bleeding occurring during OAC + clopidogrel intake.
Measured: 44 months
Secondary outcomes (1)
Ischemic stroke (efficacy)
assessed by MRI/CTA
Measured: 68 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start9 Jan 2026
- Primary completion20 Dec 2028 (estimated)
- Study completion20 Oct 2030 (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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized, open-label, blinded endpoint evaluation
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Javelin Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- World Health Research Institute
- Responsible party
- Sponsor
- Investigators
- Ashkan Shoamanesh, MD, FRCPC, Principal investigator, Population Health Research Institute, McMaster UniversityAlexander P Benz, MD MSc, Principal investigator, Population Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05723926
- Sponsor's protocol ID
- CL-500
- Acronym
- INTERCEPT
- Status last verified
- Aug 2026
- First submitted
- 18 Jan 2023
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carotid Implants for PreveNtion of STrokE ReCurrEnce From Large Vessel Occlusion in Atrial Fibrillation Patients Treated With Oral Anticoagulation
- ClinicalTrials.gov ID
- NCT05723926
- Acronym / sponsor ID
- INTERCEPT / CL-500
- Conditions
- Atrial Fibrillation, Oral Anticoagulation, Stroke, Implant
- Keywords
- Filter, Ischemic stroke, NOAC, LVO
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Javelin MedicalIndustry (pharma, biotech, devices)
- Collaborators
- World Health Research Institute
- Study start
- 9 Jan 2026 (actual)
- Primary completion
- 20 Dec 2028 (estimated)
- Study completion
- 20 Oct 2030 (estimated)
- First posted
- 13 Feb 2023 (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.
Patients with atrial fibrillation (AF) who have had a prior stroke are at very high risk of recurrent ischemic stroke. About 40% of these strokes are due to large emboli which result in large cerebral vessel occlusion (LVO). This randomized control trial aims to address this unmet need by testing whether use of bilateral carotid filter implants in addition to OAC will reduce the risk of stroke in AF patients with recent (e.g. within 12 months) ischemic stroke vs. only OAC.
Detailed description
Patients with atrial fibrillation (AF) who have had a prior stroke are at very high risk of recurrent ischemic stroke. Oral anticoagulation (OAC) is very effective for stroke reduction, but despite this treatment, AF patients with stroke in the past year still have a very high risk of recurrent stroke which is often disabling; estimated to be between 3 and 7% per year. About 40% of these strokes are due to large emboli which result in large cerebral vessel occlusion (LVO). Thus, there is a well-documented unmet medical need to improve stroke reduction therapy for AF patients with prior ischemic stroke. This study aims to address this unmet need by testing whether use of bilateral carotid filter implants in addition to OAC will reduce the risk of stroke in AF patients with recent (e.g. within 12 months) ischemic stroke. These filters have been shown, in vitro, to capture all emboli ≥1.4 mm in length or diameter and additionally to capture some emboli of smaller diameter. Once placed bilaterally in the common carotid arteries, they are expected to prevent most emboli ≥1.4 mm in length or diameter and potentially some smaller ones from reaching the anterior cerebral circulation. Although the posterior circulation will not be protected, the majority of all large ischemic strokes in patients with AF occur in the anterior circulation (about 90%). It is hypothesized therefore that bilateral carotid implants will greatly reduce embolic strokes due to LVO (60% reduction) and will have an important but smaller effect on embolic strokes due to smaller emboli which cause non-LVO occlusion (10% reduction). LVO-associated strokes are more often large and disabling compared to non-LVO strokes. The primary goal of the study is to show that bilateral carotid implants reduce strokes due to LVO and that there is also a reduction in total ischemic stroke, both in comparison to a control arm (treatment with OAC only). The study will also evaluate the safety of the intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, randomized, open-label, blinded endpoint evaluation
| Arm | Type | Receives |
|---|---|---|
| Vine Filter and oral anticoagulant | Experimental | Device: Vine FilterParticipants randomized to the intervention will undergo implantation of bilateral carotid filters and OAC therapy. In addition, participants will receive additional single antiplatelet therapy with OAC for 6 months. |
| Usual Care (oral anticoagulant only) | No intervention | –Participants randomized to control will not receive carotid filter implants but will receive usual care including OAC, throughout the course of the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Documented history of clinical AF
- 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
- Planned use of a Vitamin K antagonist (VKA) or a direct oral anticoagulant (DOAC) for the duration of the trial
- Patient able to tolerate single antiplatelet therapy in addition to oral anticoagulation for 6 months, in the opinion of the investigator
Key exclusion criteria (13 listed)
- Contraindication to oral anticoagulation (e.g. history of intracranial hemorrhage, known hereditary or acquired coagulation disorders, or recurrent major bleeding)
- Contraindication to additional single antiplatelet therapy for 6 months from randomization
- 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)
- 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
- 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.
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 FilterAlso: Vine Embolic Protection SystemThe Vine filters are designed to be implanted in the common carotid arteries in order to capture emboli coming from the heart or great vessels, before they can enter the anterior intracranial circulation. The filter is deployed percutaneously using a 22G needle under ultrasound guidance. | Device | Vine Filter and oral anticoagulant |
Primary outcome
Large vessel occlusion strokes (efficacy)
Time frame: 44 months
assessed by MRI/CTA
Serious device or procedure related complications (safety)
Time frame: 44 months
Defined as any carotid filter or procedure related complication (excluding ischemic stroke) that results in death) or major disability, or that requires endovascular stenting or surgical correction.
ISTH (International Society on Thrombosis and Haemostasis) major bleeding occurring during OAC + clopidogrel intake.
Time frame: 44 months
1 secondary outcome
Ischemic stroke (efficacy)
Time frame: 68 months
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 19 Aug 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
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.
Jessica Tyrwhitt contact
Ashkan Shoamanesh, MD, FRCPC principal investigator
Population Health Research Institute, McMaster University
Alexander P Benz, MD MSc principal investigator
Population Health Research Institute
21 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vine Filter in people with Atrial Fibrillation and Oral Anticoagulation, run by Javelin Medical at 21 sites in 4 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 14 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 19 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 21 sites in Brazil, United States, Georgia, Canada. 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?
Contact Sagit Broder, MSc (+972587112116, sagit@javelinmed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Large vessel occlusion strokes (efficacy) (time frame: 44 months). The study lists 3 primary outcomes in all. 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 19 Aug 2026.