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Background

Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia and a leading cause of cardioembolic ischemic stroke. These strokes are frequently caused by large thrombi that produce large-vessel occlusions (LVOs), and they more often result in severe disability or death compared with strokes from other causes (Figure 1). While long-term use of oral anticoagulation (OAC) is effective in reducing stroke risk, a significant residual risk remains, particularly in patients with a history of recent stroke.

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Figure 1: Imaging examples of ischemic stroke events. Occlusion of a large vessel such as the M1 segment of the MCA typically leads to large cerebral infarction (A). Occlusion of smaller, more distal vessels typically lead to smaller cerebral infarctions (B)

Although OACs, including vitamin K antagonists (VKAs) and direct oral anticoagulants (DOACs), are standard of care for stroke prevention in patients with AF, they do not eliminate stroke risk. Adherence, dose management, and individual variability can all compromise efficacy. AF patients who experience a stroke while receiving OAC therapy are at particularly high risk of recurrent stroke, with rates ranging from 3-7% at one year¹ ,².

There is a strong biological and clinical rationale for combining pharmacologic therapy with a mechanical treatment to try to optimize stroke prevention. The Vine™ Embolic Protection System is an investigational mechanical device which, in addition to OAC, is designed to prevent large emboli from reaching the anterior cerebral circulation.

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WARNING: Carefully read all the instructions prior to use. Failure to observe all warnings and precautions may result in complications.

The Vine™ system should only be used by trained physicians who are familiar with the clinical risks, benefits, potential complications, side effects, and principles of operation.

 

General:

  • The appropriate anti-thrombotic therapy should be administered pre-and post-procedure, as suggested in this IFU.

  • Special considerations should be taken into account in patients with recently active gastritis or peptic ulcer disease.

  • If cerebral access is required, the implant can be crossed with a 6F catheter. However, the implant may become distorted, and restoration [of the implant] maybe needed by snaring (as observed in animal studies).

  • The operator should be proficient in performing needle-based procedures under ultrasound guidance.

  • For better insertion needle visibility, it is strongly recommended to use a high-resolution ultrasound machine.

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 Specific:

  • Motor Unit:

    • The Motor Unit should not be used in high oxygen concentration areas.

    • The Motor Unit is not GP-rated and should not be used in conjunction with flammable anesthetics.

    • Two Motor Units should be prepared for each implantation procedure (one for backup).

    • The Motor Unit should be fully charged (green LED on) prior to use.

    • The Motor Unit must be cleaned and disinfected before and after each patient usage.

    • The Motor Unit should be stored in its original box between usages.

    • The Motor Unit should be stored in a room-temperature environment.

    • No maintenance or calibration is required prior to use.

  • Charger:

    • The Charger should be stored in a room-temperature environment.

    • No maintenance or calibration is required prior to use.

    • The Charger must be cleaned and disinfected before Motor Unit storage (after each patient usage).

  • Vine System: The system should be used only with a single use sterile barrier cover

 

PRECAUTIONS

  • The Needle Unit pouch and the protective package should be opened only in an aseptic environment and using gloves.

  • Carefully inspect the Needle Unit prior to use.

  • The Needle Unit should not be used if the insertion needle is kinked or if there is a section of the implant protruding from the distal end of the insertion needle.

 

CONTRAINDICATIONS

  • Contraindications for OAC or single antiplatelet therapy. 

  • Visualized active (acute/subacute) cervical or intracranial arterial (i.e., free-floating) thrombus.

  •  A known history of aneurysm in the internal carotid artery or its branches that is 6 mm or greater in diameter. 

  • Prior surgery at the implantation segment. 

  • Radiation of the neck. 

  • Overt systemic infection. 

  • Known sensitivity to nickel or titanium metals, or their alloys.​​

¹ Seiffge DJ, De Marchis GM, Koga M, et al. Ischemic Stroke despite Oral Anticoagulant Therapy in Patients with Atrial Fibrillation. Ann Neurol 2020; 87(5): 677 - 87.

² Rost NS, Giugliano RP, Ruff CT, et al. Outcomes with Edoxaban Versus Warfarin in Patients with Previous Cerebrovascular Events: Findings From ENGAGE AF-TIMI 48 (Effective Anticoagulation with Factor Xa Next Generation in Atrial Fibrillation- Thrombolysis in Myocardial Infarction 48). Stroke 2016; 47(8): 2075 - 82.

Trial Design​​

INTERCEPT (Carotid Implants for PreveNtion of STrokE ReCurrEnce from Large Vessel Occlusion in Atrial Fibrillation Patients Treated with Oral Anticoagulation) is an international, prospective, randomized, open-label, blinded-endpoint trial (PROBE design). This trial aims to evaluate the efficacy and safety of the Vine™ Embolic Protection System, which includes the Vine™ Filter (a permanent bilateral common carotid artery filter) and Vine™ Inserter, in AF patients  with an ischemic stroke in the previous year. All study participants receive oral anticoagulation throughout the duration of the trial. Participants randomized to receive bilateral carotid filters also receive additional single antiplatelet therapy (clopidogrel) for 6 months post-implantation.

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The primary efficacy endpoint is anterior circulation ischemic stroke due to LVO. The powered secondary efficacy endpoint is total ischemic stroke. The primary safety endpoints are (1) serious device- or procedure-related complications and (2) ISTH major bleeding occurring during the first 6 months post-randomization.

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Randomization​

Eligible participants are randomized 1:1 to either receive or not to receive bilateral carotid filters.

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Implantation Procedure

Patients randomly assigned to receive the carotid filters will undergo bilateral implantation of carotid filters. Patients must be on OAC and additional single antiplatelet therapy at the time of the procedure. The carotid filters are implanted under ultrasound guidance. The total implantation procedure will take approximately one hour. After the procedure, patients remain in the hospital for monitoring, as determined by the treating physician. 

United States only: After the procedure, patients will be required to stay in the hospital overnight.

Implantation Procedure

Javelin Website Video_Master_Subtitles_Reduced Size

Follow-Up​

Participants are followed for up to 8 years (average 5 years) through in-person or phone visits. These follow-up visits include structured interviews using the Questionnaire for Verifying Stroke-Free Status (QVSFS), review of endpoint and adverse events, and medication updates. Visits occur every 3 months in the first year and every 6 months thereafter. Annual and final visits include mRS¹, SAGEA², and EQ-5D-5L³ assessments (EQ-5D-5L completed only in the US/Canada). If a stroke occurs, mRS and EQ-5D-5L are repeated 90 days after symptom onset.

 

¹ mRS (Modified Rankin Scale): A commonly used scale for measuring the degree of disability or dependence in daily activities of people who have suffered a stroke.

² SAGEA:  Stroke-specific Assessment of Global Everyday Activities, measures stroke-related functional ability.

³ EQ-5D-5L:  A standardized questionnaire used to assess health-related quality of life across five dimensions at five levels (US/Canada only).

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Study Oversight​

An independent Data and Safety Monitoring Board (DSMB) reviews unblinded efficacy and safety data at regular intervals. All potential stroke cases are adjudicated by a separate expert committee blinded to assigned treatment.

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Study Population

AF patients with ischemic stroke within the past year, expected to receive OAC. 

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Study Design

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Two primary safety endpoints:

  1. Serious device or procedure related complication

  2. ISTH major bleeding occurring during the first 6 months post randomization

Figure 2: INTERCEPT study scheme. 

The Vine™ Embolic Protection System

The device is designed to protect the anterior cerebral circulation from large proximally originating emboli. It consists of the Vine™ Filter (implant) and Vine™ Inserter (Figure 3).

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Figure 3:The Vine™ Embolic Protection System

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Figure 4:  Vine™ Filter

Vine™ Filter​

The Vine™ Filter is a permanent filter device placed bilaterally in the common carotid arteries (CCA) and designed to capture thrombi ≥1.4 mm in diameter or length . It is deployed percutaneously under ultrasound guidance. Once implanted, the device assumes a helical shape within the artery lumen with a linear stem traversing the wall of the vessel. Besides the actual filtering portion, the helix includes supporting and leading coils (Figure 4). Retraction of the device by the pulling wire is possible immediately and up until 4 hours after implantation. The device has been evaluated in preclinical and clinical studies³ ⁴  including more than 100 patients, follow-up of up to 6 years (in total, more than 335 patients/year). 

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³ Yodfat O, Shinar G, Neta A, et al. A permanent common carotid filter for stroke prevention in atrial fibrillation: Ex vivo and In Vivo Pre-Clinical testing. Cardiovascular Revascularization Medicine  2020; 21(12): 1587-93. 

⁴  Reddy VY, Neuzil P, De Potter T, et al. Permanent percutaneous carotid artery filter to prevent stroke in atrial fibrillation patients. Journal of the American College of Cardiology 2019; 74(7): 829 - 39. 

Vine™ Inserter

The Vine™ Inserter is a two-part deployment system (Figure 5):

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Needle Unit: A sterile, single-use 22G needle preloaded with the filter. It includes a color-coded orientation flag (red for right, blue for left carotid artery).

 

Motor Unit: A reusable, non-sterile device containing the motor and gear mechanism. When connected to the Needle Unit, the motor automates the deployment of the filter upon activation.

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Figure 5: The Needle Unit for the right (A) and left (B) common carotid artery, and the Motor Unit (C)

Indication for Use:

To reduce the risk of anterior circulation ischemic stroke due to LVO in AF patients with history of stroke suitable for chronic OAC.

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Intended Users

The implant deployment procedure is designed to be performed by trained physicians such as:

  • Vascular surgeons (VS)

  • Interventional neuro-radiologists (INR)

  • Interventional radiologists (IR)

  • Interventional cardiologists (IC)

  • Electro-physiologists (EP)​​

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Study Outcomes​

 

Efficacy Endpoints:​

  • Primary: Reduction in anterior circulation ischemic stroke due to LVO

  • Secondary: Reduction in total ischemic stroke

 

Safety Endpoints:

  • Primary:

    • Serious device/procedure-related complication

    • ISTH major bleeding within 6 months

Inclusion and Exclusion Criteria

 

Inclusion Criteria:

  • Documented history of clinical AF

  • History of ischemic (i.e., non-hemorrhagic) stroke, including symptoms of stroke resolving within 24 hours with positive imaging, meeting one of the following criteria:

Group 1: Patient was on OAC at time of index stroke, with index stroke occurring <6 weeks before randomization.

Group 2: Patient was not on OAC at time of stroke, with index stroke occurring <6 weeks before randomization.

Group 3: Patient was on OAC at time of index stroke, with index stroke occurring 6 to 52 weeks before randomization

  • Planned use of a VKA or a DOAC for the duration of the trial

  • Investigator believes patient is able to tolerate single antiplatelet therapy in addition to OAC for 6 months

  • Bilateral ultrasound or angiogram, demonstrating all of the following:

  • 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, the percentage of carotid stenosis is to be calculated 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 ³125 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, the percentage of carotid stenosis is to be calculated 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

Exclusion Criteria:

  • Contraindication to OAC (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 ³50% stenosis, or high-risk plaque in the opinion of the investigator, of the common 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., freefloating) 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

  • 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 the duration of the trial

  • Overt systemic infection (e.g., bacteremia)

  •  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

For the CAPTURE and CAPTURE2 results, please see the latest publications on the News & Publications page.

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