Status: No Longer Enrolling
Do you need treatment for carotid artery stenosis?
If you have carotid artery stenosis, this study may be an option for you.
This study will 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.
Candidates for GORE® Carotid Stent Study
You may qualify for this study if you:
- 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
Study Length & Information: 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.
Principal Investigator: Jeffrey M. Slaiby, MD, FACS, RPVI