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

Prior treatment

• Any planned surgical or endovascular treatment within 30 days after the implantation procedure
• Active participation in another investigational drug or device treatment study

Other illness

• Active systemic infection
• Known hereditary or acquired coagulation disorders
• 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)
• 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

Other

• 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
• Known sensitivity to nickel or titanium metals, or their alloys
• Inability to complete all scheduled follow-up

• 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