Carotid Implants for PreveNtion of STrokE ReCurrEnce From Large Vessel Occlusion in Atrial Fibril… (NCT05723926) | Clinical Trial Compass
RecruitingNot Applicable
Carotid Implants for PreveNtion of STrokE ReCurrEnce From Large Vessel Occlusion in Atrial Fibrillation Patients Treated With Oral Anticoagulation
Canada2,000 participantsStarted 2026-01-09
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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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 neuro-imaging, meeting one of the following criteria:
✓. 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
Exclusion criteria
✕. Contraindication to oral anticoagulation (e.g. history of intracranial hemorrhage, known hereditary or acquired coagulation disorders, or recurrent major bleeding)
What they're measuring
1
Large vessel occlusion strokes (efficacy)
Timeframe: 44 months
2
Serious device or procedure related complications (safety)
Timeframe: 44 months
3
ISTH (International Society on Thrombosis and Haemostasis) major bleeding occurring during OAC + clopidogrel intake.
✕. 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
✕. 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