Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
312 participants
INTERVENTIONAL
2013-07-31
2020-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Carotid Artery Stenting
Carotid Artery Stenting with the GORE® Carotid Stent
Carotid Artery Stenting
Carotid Artery Stenting with the GORE® Carotid Stent
Interventions
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Carotid Artery Stenting
Carotid Artery Stenting with the GORE® Carotid Stent
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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W.L.Gore & Associates
INDUSTRY
Responsible Party
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Principal Investigators
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William Gray, MD
Role: PRINCIPAL_INVESTIGATOR
Lankenau Heart Institute
Peter Schneider, MD
Role: PRINCIPAL_INVESTIGATOR
Kaiser Health System, Honolulu
Locations
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Kaiser Permanente Hawaii
Honolulu, Hawaii, United States
Lankenau Heart Institute
Wynnewood, Pennsylvania, United States
Countries
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References
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Gray WA, Levy E, Bacharach JM, Metzger DC, Randall B, Siddiqui A, Schonholz C, Alani F, Schneider PA. Evaluation of a novel mesh-covered stent for treatment of carotid stenosis in patients at high risk for endarterectomy: 1-year results of the SCAFFOLD trial. Catheter Cardiovasc Interv. 2020 Jul;96(1):121-127. doi: 10.1002/ccd.28586. Epub 2019 Nov 11.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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GCS 10-08
Identifier Type: -
Identifier Source: org_study_id