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.
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.
Symptomatic carotid stenosis ≥ 50%. Symptomatic is defined as amaurosis fugax, transient ischemia attack (TIA) or stroke within the last 6 months ipsilateral to the side of the stenosis Or
Asymptomatic carotid stenosis ≥ 80%
Patient had or will have an interventional procedure or surgery of the carotid, coronary or peripheral arteries within 30 days before or after the index carotid procedure.
Patient had or will have open heart surgery or valvular intervention (percutaneous or surgical), or any major operation, within 30 days before or after the index carotid procedure.
Vascular anatomy that would preclude safe sheath insertion or deliverability of stent
Patient had a previously placed stent in the ipsilateral ICA or CCA.
InspireMD
Lead sponsor
Washington University School of Medicine
Collaborator
TriHealth Inc.
Collaborator
NAMSA
Collaborator