Status:
COMPLETED
The Gore SCAFFOLD Clinical Study
Lead Sponsor:
W.L.Gore & Associates
Conditions:
Carotid Artery Disease
Carotid Artery Stenosis
Eligibility:
All Genders
18+ years
Phase:
NA
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 p...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2020
Estimated Enrollment :
312 Patients enrolled
Trial Details
Trial ID
NCT01901874
Start Date
July 1 2013
End Date
September 1 2020
Last Update
October 29 2020
Active Locations (2)
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1
Kaiser Permanente Hawaii
Honolulu, Hawaii, United States, 96819
2
Lankenau Heart Institute
Wynnewood, Pennsylvania, United States, 19096