The Gore SCAFFOLD Clinical Study

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Carotid Artery Disease, Carotid Artery Stenosis

Intervention / Treatment
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* Device: Carotid Artery Stenting


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Carotid Artery Stenting<br>Carotid Artery Stenting with the GORE® Carotid Stent | Device: Carotid Artery Stenting<br>* Carotid Artery Stenting with the GORE® Carotid Stent<br>* Other names: GORE® Carotid Stent;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Experienced Major Adverse Events (MAE) at One Year | 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). | 365 days | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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