Carotid Implants for PreveNtion of STrokE ReCurrEnce From Large Vessel Occlusion in Atrial Fibrillation Patients Treated With Oral Anticoagulation

Prior treatment

• 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)
• 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
• Active participation in another investigational drug or device treatment trial

Other illness

• Contraindication to oral anticoagulation (e.g. history of intracranial hemorrhage, known hereditary or acquired coagulation disorders, or recurrent major bleeding)
• 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
• Pre-existing percutaneous left atrial appendage occlusion device that was implanted after most recent ischemic stroke
• Overt systemic infection
• 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

Other

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

• 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:
  • 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