The EMBOLDEN study was conducted to test the safety and efficacy of a novel emboli protection filter design for use in carotid artery stenting (CAS) in patients with severe carotid stenosis who were at high risk of operative complications from carotid endarterectomy (CEA).General considerations for filter design usually involve trade-offs between trackability/profile and wall apposition/capture efficiency. The GORE® Embolic Filter (GEF) is intended to address these design goals via a hybrid construction.Patients at high risk for CEA (N?=?250) were treated with CAS using the GEF study device paired with an FDA-approved carotid stent. The primary outcome was death, stroke, and myocardial infarction (MI) at 30 days, compared to a pre-determined performance goal. Neurologic outcomes were judged by an independent assessor and angiographic results evaluated by an independent central core lab.The GEF study device was successfully deployed in 96.4% of procedures. The primary endpoint of 30-day death, stroke, and MI occurred in 4.0% of subjects and was significantly lower than the pre-defined performance goal (P?
View details for DOI 10.1002/ccd.27474
View details for PubMedID 29314704