GORE® Embolic Filter in Carotid Stenting for High Risk Surgical Subjects (EMBOLDEN)
Condition: Carotid Artery Stenosis
MeSH terms: Carotid Stenosis
Intervention: GORE® Embolic Filter
Intervention description: Embolic protection during carotid stenting
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 250.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: carotid artery stenosis; embolic protection device; distal embolic filter; minimizing risks of carotid artery stenting

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. 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

          2. Target lesion is located in one of the following:

               -  ICA

               -  bifurcation

               -  CCA proximal to the bifurcation

          3. 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