Clinical trial NCT00766493: GORE® Embolic Filter in Carotid Stenting for High Risk Surgical Subjects (EMBOLDEN)
Official title: GORE® Embolic Filter in Carotid Stenting for High Risk Surgical Subjects (GORE EMBOLDEN)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Carotid Artery Stenosis
Keywords: carotid artery stenosis
embolic protection device
distal embolic filter
minimizing risks of carotid artery stenting
Lead sponsor: W.L.Gore & Associates
Sponsor class: INDUSTRY
First posted: 2008-10-06
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Composite Major Adverse Event (MAE) Rate of Death, Myocardial Infarction, and Stroke at 30 Days Postprocedure
timeFrame: 30 days
Secondary outcomes:
measure: Device Success
timeFrame: Post Procedure
measure: Clinical Success
timeFrame: 30 days
measure: Access Site Complications
timeFrame: 30 days
measure: Neurologic Events
timeFrame: 30 days
Other outcomes:
Locations:
Study officials:
affiliation: Columbia University
name: William A. Gray, MD
role: PRINCIPAL_INVESTIGATOR
References: