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
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:
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- 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
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- 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