The Gore SCAFFOLD Clinical Study

Completed · Not applicable

Conditions studied: Carotid Artery Disease, Carotid Artery Stenosis

In brief

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

Key facts

Study ID

NCT01901874

Run by

W.L.Gore & Associates

People needed

312

Starts

2013-07-01

Expected to finish

2020-09-01

Last updated by the study team

2020-10-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Kaiser Permanente Hawaii — Honolulu, Hawaii, United States
• Lankenau Heart Institute — Wynnewood, Pennsylvania, United States

Full record on ClinicalTrials.gov

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