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.
Documented history of clinical AF
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
Inner common carotid artery diameter range: ≥5.3 mm and ≤8.8 mm
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
Parallel
Vine Filter
DeviceThe 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.
Large vessel occlusion strokes (efficacy)
assessed by MRI/CTA
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.
ISTH (International Society on Thrombosis and Haemostasis) major bleeding occurring during OAC + clopidogrel intake.
Ischemic stroke (efficacy)
assessed by MRI/CTA
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Javelin Medical
Lead sponsor
World Health Research Institute
Collaborator
