The Gore SCAFFOLD Clinical Study

Not Applicable

Completed

Brief Summary: 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

Detailed Description: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Carotid Artery Stenting	Carotid Artery Stenting	Carotid Artery Stenting with the GORE® Carotid Stent

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Experienced Major Adverse Events (MAE) at One Year	365 days	MAE defined as any death, stroke, or myocardial infarction through 30 days post-index procedure, or ipsilateral stroke between 31 days and 1 year (365 days).

Secondary Outcome Measures

Name	Time	Method
Number of Participants Who Achieved Procedure Success	Procedural	Procedure Success defined as Stent Technical Success with \< 30% residual stenosis and no in-hospital MAE.
30-Day MAE - Myocardial Infarction	30 days	Any myocardial infarction through 30 days post-index procedure
Number of Participants Who Experienced MAE at 30 Days	30 days	Defined as any death, stroke, or myocardial infarction through 30 days post-index procedure.
Target Lesion Revascularization	365 days	Any clinically driven revascularization procedure that is performed to increase the luminal diameter inside or within 5 mm of the previously treated lesion
Number of Participants Who Achieved Stent Technical Success	Procedural	Stent Technical Success defined as successful implantation of a GORE® Carotid Stent
In-Stent Restenosis	365 days	≥80% diameter stenosis within the stented lesion or within 5 mm proximal or distal to the stent at follow-up evaluation by core lab angiographic analysis
30-Day MAE - Death	30 days	Any cause death through 30 days post-index procedure
Number of Participants Who Achieved Embolic Protection Device (EPD) Technical Success	Procedural	EPD Technical Success defined as GORE® Embolic Filter delivered, placed, and retrieved without requiring assisting interventional methods.
30-Day MAE - Stroke	30 days	Any stroke through 30 days post-index procedure