The Gore SCAFFOLD Clinical Study

This is an interventional treatment trial for Carotid Artery Disease focused on measuring Stroke, Carotid Artery Stenting (CAS), Embolic Protection Device (EPD), Stent, Carotid Stenosis, Constriction, Pathologic, Carotid Artery Diseases, Cerebrovascular Disorders, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Arterial Occlusive Diseases, Vascular Diseases, Cardiovascular Diseases, Pathological Conditions, Anatomical, Angioplasty Read More

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