The Gore SCAFFOLD Clinical Study
The Gore SCAFFOLD Clinical Study
Evaluate the safety and efficacy of the GORE® Carotid Stent for the treatment of carotid
 artery stenosis in patients at increased risk for adverse events from carotid endarterectomy
This is a prospective, multicenter, single-arm clinical study comparing outcomes with the
 GORE® Carotid Stent to a performance goal derived from carotid endarterectomy outcomes in
 high-surgical-risk patients.
Inclusion Criteria:

 -  Patient is at least 18 years old at informed consent

 -  Patient is willing and capable of complying with all study protocol requirements,
 including specified follow-up period and can be contacted by telephone.

 -  Patient is willing to provide written informed consent prior to enrollment in study.

 -  Patient is either:

 -  Symptomatic with carotid stenosis ≥50% as determined by angiography using NASCET
 methodology. Symptomatic is defined as amaurosis fugax ipsilateral to the carotid
 lesion; Transient Ischemic Attack (TIA) or non-disabling stroke within 180 days
 of the procedure within the hemisphere supplied by the target vessel; OR

 -  Asymptomatic with carotid stenosis ≥80% as determined by angiography using NASCET
 methodology

 -  Patient must be considered high risk for adverse events during carotid endarterectomy

 Note: Additional inclusion criteria may apply

 Exclusion Criteria:

 -  Patient has life expectancy of less than one year.

 -  Patient is experiencing (or has experienced) an evolving, acute, or recent disabling
 stroke.

 -  Patient has anticipated or potential sources of emboli (e.g. atrial fibrillation,
 known previously symptomatic patent foramen ovale (PFO), mechanical heart valve, or
 Deep Vein Thrombosis (DVT) treated within 6 months).

 -  Patient has had an acute myocardial infarction within 72 hours prior to the index
 procedure.

 -  Patient has a history of major, disabling ipsilateral stroke with residual deficit
 that may confound the neurological subject assessments.

 -  Patient has known severe carotid stenosis contralateral to the target lesion requiring
 treatment within 30 days following the index procedure.

 Note: Additional exclusion criteria may apply