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Carotid Revascularization Endarterectomy vs Stenting Trial (CREST)

The primary goal of CREST is to assess if the efficacy of CAS differs from that of CEA over a multi-year time horizon. Data from CREST will be used to both provide an assessment of the differential efficacy of CEA and CAS and support a submission to the FDA for an indication for CAS for the subject device. Two separate analyses will be performed for this study. First, a traditional difference assessment as described in the NIH submission, and second an equivalency analysis for submission to the FDA.

The primary goal of CREST is to assess if the efficacy of CAS differs from that of CEA over a multi-year time horizon. Data from CREST will be used to both provide an assessment of the differential efficacy of CEA and CAS and support a submission to the FDA for an indication for CAS for the subject device. Two separate analyses will be performed for this study. First, a traditional difference assessment as described in the NIH submission, and second an equivalency analysis for submission to the FDA.