InspireMD
The objective of this study is to evaluate acute device and technical success of the CGuard Prime™ Carotid Stent System (80cm) when used in conjunction with the Enroute NPS during Transcarotid Artery Revascularization procedures in the treatment of carotid artery stenosis in spatients at high risk for adverse events from carotid endarterectomy.
This study is a prospective, multi-center, single arm pivotal study. The study shall not be blinded prior to, during or following the procedure. Patients undergoing transcarotid artery revascularization will be screened against the study inclusion/exclusion criteria. If the patient meets study eligibility requirements, they shall be invited to participate, provide informed consent and shall subsequently be assigned a study ID number. Enrollment will be a minimum of 50 evaluable pivotal patients. A maximum of 20% of patients will be enrolled at any single site. The total enrollment accounts fo…
INCLUSION CRITERIA: Candidates for participation in the study must meet all of the following general inclusion criteria. * Patient is ≥ 18 years and \< 80 years of age. * Patient is willing and able to provide appropriate study-specific informed consent, follow protocol procedures, and comply with follow-up visit requirements. * Patient is diagnosed with carotid artery disease treatable with a Carotid Artery Stent via a Transcarotid Artery Revascularization approach and is either symptomatic or asymptomatic, defined as: * Symptomatic carotid stenosis ≥ 50%. Symptomatic is defined as amaurosis…
This study is single arm looking at the technical success of the CGuard Prime 80cm stent system when used in conjunction with the FDA-cleared ENROUTE NPS during a TCAR procedure.