The Gore SCAFFOLD Clinical Study

GORE® Carotid Stent Clinical Study for the Treatment of Carotid Artery Stenosis in Patients at Increased Risk for Adverse Events From Carotid Endarterectomy

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