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.
Single group
CGuard Prime 80cm stent system
DeviceThis 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.
Acute device success
Successful insertion of the delivery system, successful deployment of the CGuard Prime™ 80 stent, and successful retraction of the delivery system when used in conjunction with the FDA-cleared ENROUTE NPS during a TCAR procedure.
Technical success
Technical Success Rate is defined as the number of patients with at least one CGuard Prime™ 80 device successfully delivered and deployed with final residual diameter stenosis \< 30% following final post-balloon dilatation (if performed) divided by the total number of patients where CGuard Prime™ 80 device deployment was attempted when used in conjunction with the FDA-cleared ENROUTE NPS during a TCAR procedure.
Procedural success
Acute device success for CGuard PrimeTM 80 Delivery System and Stent without experiencing death, stroke or MI through 30-day post-procedure when used in conjunction with the FDA-cleared ENROUTE NPS during a TCAR procedure.
Treatment success
Treatment Success Rate is defined as the number of patients who meet CGuard Prime™ 80 Technical Success Rate without experiencing death, stroke or MI through 30-day post-procedure, divided by the total number of patients where CGuard Prime™ 80 device deployment was attempted when used in conjunction with the FDA-cleared ENROUTE NPS during a TCAR procedure.
Occurence of Hierarchical Death, Stroke or Myocardial Infarction (DSMI) within 30 days of the procedure
Hierarchical Death or Stroke rate within 30 days of the procedure
Click on the lead sponsor to view all of their trials.
InspireMD
Lead sponsor
Washington University School of Medicine
Collaborator
TriHealth Inc.
Collaborator
NAMSA
Collaborator
