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The objective of the CANOPY trial is to assess the continued safety and effectiveness of the RX Acculink Carotid Stent System under commercial use in subjects at standard risk for adverse events from Carotid Endarterectomy (CEA) enrolled by physicians with a range of carotid stenting experience.
Enrollment
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Inclusion criteria
Subject must be ≥ 18 years of age.
Subject does not have any condition that limits their anticipated survival to less than 3 years.
Subject or a legally authorized representative must provide written informed consent prior to any trial related procedure.
Subjects with neurological symptoms within 180 days of the procedure and ≥ 70% stenosis of the common or internal carotid artery by ultrasound or ≥ 50% stenosis of the common or internal carotid artery by angiogram - OR-
Subjects without neurological symptoms within 180 days of the procedure and ≥ 70% stenosis of the common or internal carotid artery by ultrasound or ≥ 60% stenosis of the common or internal carotid artery by angiogram.
Subject with all the following target vessel characteristics:
Subject must agree not to participate in any other clinical trial for a period of 1 year following the index procedure.
Exclusion criteria
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Interventional model
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1,203 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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