Status:
COMPLETED
GORE® Embolic Filter in Carotid Stenting for High Risk Surgical Subjects (EMBOLDEN)
Lead Sponsor:
W.L.Gore & Associates
Conditions:
Carotid Artery Stenosis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 embol...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT00766493
Start Date
January 1 2009
End Date
July 1 2010
Last Update
September 29 2016
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