Carotid Artery Implant for Preventing Stroke in Atrial Fibrillation Patients Taking Oral Anticoagulants

Study Overview
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Brief Summary
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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
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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 > 1.2mm 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

Official Title
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Carotid Artery ImPlant for Trapping UpstReam Emboli (CAPTURE 2) for Preventing Stroke in Atrial Fibrillation Patients Taking Oral Anticoagulants

Conditions
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Stroke, Atrial Fibrillation

Intervention / Treatment
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* Device: Vine™ Embolic Protection System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vine™ Filter + OAC<br>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 | Device: Vine™ Embolic Protection System<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 30 days from implantation procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | one and two years from implantation procedure | 
| Number of properly positioned implants | proper implant position in each common carotid artery (CCA) | 30 days from implantation procedure | 
| Number of participants that had disabling strokes | Disabling stroke | 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 | immediately after the procedure | 
| Number of properly positioned implants | Proper implant position in each CCA | one and two years from implantation procedure | 
| Number of observed thrombi on the device | Thrombus on implant detected by ultrasound imaging | 30 days, one and two years from implantation procedure | 
| Number of death cases | Death | one and two years from implantation procedure | 
| Number of strokes (any kind) | Total number of strokes | one and two years from implantation procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AF, Stroke, Filter, Emboli, Carotid, OAC