GORE® Embolic Filter in Carotid Stenting for High Risk Surgical Subjects (EMBOLDEN)

Phase 3

Completed

Brief Summary: Compare the 30-day safety and efficacy of the GORE® Embolic Filter used in conjunction with FDA-approved carotid stents to a performance goal obtained from carotid stent studies utilizing distal embolic protection.

Detailed Description: Continuous advances in angioplasty techniques and the development of low-profile, flexible, tapered nitinol stents designed specifically for carotid applications have made CAS a viable alternative to CEA. Advances in embolic protection technology will assist in moving CAS forward as a universally accepted procedure. While the GORE® Embolic Filter is similar in many ways to other currently available filters, it has been designed to provide optimal vessel wall apposition. Bench tests suggest that the wall apposition may provide improved filter efficiency, thereby minimizing embolization of particles downstream and potentially decreasing adverse clinical effects. In addition, preclinical testing suggests that the GORE® Embolic Filter has improved deliverability, including torque ability and lesion cross that may improve the ability of the system to access and treat tight lesions in tortuous anatomy. Thus, the purpose of this multi-center clinical study is to assess the safety and effectiveness of the GORE® Embolic Filter when used to provide cerebral embolic protection during carotid artery angioplasty and stenting.

Recruitment & Eligibility

Inclusion Criteria

Subject is either:
- Symptomatic (amaurosis fugax in the hemisphere supplied by the target vessel, TIA or non-disabling stroke within 6 months of the procedure) with carotid stenosis ≥50% as diagnosed by angiography using NASCET methodology, OR
- Asymptomatic with carotid stenosis ≥80% as diagnosed by angiography using NASCET methodology
Target lesion is located in one of the following:
- ICA
- bifurcation
- CCA proximal to the bifurcation
At Anatomic risk for adverse events from CEA (e.g., restenosis after a prior CEA) or at Co-morbid risk for adverse events from CEA (e.g., unstable angina with ECG changes)

Exclusion Criteria

Recent surgical procedure within 30 days before or after the stent procedure
Uncontrolled sensitivity to contrast media
Renal Insufficiency
Recent evolving, acute stroke within 21 days of study evaluation
Myocardial infarction within 72 hours prior to stent procedure
History of a prior major ipsilateral stroke with residual neurological deficits likely to confound the neurological assessments (e.g., NIHSS)
Neurological deficits not due to stroke likely to confound the neurological assessments (e.g., NIHSS)

Angiographic Exclusion Criteria:

Isolated ipsilateral hemisphere leading to subject intolerance to reverse flow
Total occlusion of the ipsilateral carotid artery
Pre-existing stent in the ipsilateral carotid artery OR the contralateral carotid artery that extends into the aortic arch
Presence of a filling defect, thrombus, occlusion or "string sign" in the target vessel
Severe lesion calcification restricting stent deployment
Carotid stenosis located distal to target stenosis that is more severe than target stenosis
>50% stenosis of the CCA proximal to target vessel
Known mobile plaque in the aortic arch

Arm && Interventions

Group	Intervention	Description
GORE® Embolic Filter	GORE® Embolic Filter	Subjects treated with the GORE® Embolic Filter and an FDA-approved carotid stent.

Primary Outcome Measures

Name	Time	Method
Composite Major Adverse Event (MAE) Rate of Death, Myocardial Infarction, and Stroke at 30 Days Postprocedure	30 days

Secondary Outcome Measures

Name	Time	Method
Device Success	Post Procedure	Device Success defined as the number of participants with Technical Success using the GORE Embolic Protection System (i.e., the GORE Embolic Filter device was delivered, placed, and retrieved as outlined in the Instructions for Use).
Clinical Success	30 days	Clinical Success defined as GORE Embolic Filter and carotid stent success in the absence of death, emergency endarterectomy, repeat PTA / thrombolysis of the target vessel, and stroke or MI as determined by the Clinical Events Committee. Clinical success will be evaluated from procedure through 24-48 hours postprocedure.
Access Site Complications	30 days	Access Site Complications defined as the presence of a large hematoma (\>5cm or requiring treatment or prolonged hospitalization), fistula or pseudoaneurysm formation, retroperitoneal bleeding or the need for surgical repair postprocedure.
Neurologic Events	30 days	Neurological Events at 30 days post-procedure, including transient ischemic attacks (TIAs).