Back to resultsGORE® Embolic Filter in Carotid Stenting for High Risk Surgical Subjects (EMBOLDEN) (EMBOLDEN)
Primary Purpose
Carotid Artery Stenosis
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
GORE® Embolic Filter
Sponsored by
About this trial
This is an interventional treatment trial for Carotid Artery Stenosis focused on measuring carotid artery stenosis, embolic protection device, distal embolic filter, minimizing risks of carotid artery stenting
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
GORE® Embolic Filter
Arm Description
Subjects treated with the GORE® Embolic Filter and an FDA-approved carotid stent.
Outcomes
Primary Outcome Measures
Composite Major Adverse Event (MAE) Rate of Death, Myocardial Infarction, and Stroke at 30 Days Postprocedure
Secondary Outcome Measures
Device Success
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
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
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
Neurological Events at 30 days post-procedure, including transient ischemic attacks (TIAs).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00766493
Brief Title
GORE® Embolic Filter in Carotid Stenting for High Risk Surgical Subjects (EMBOLDEN)
Acronym
EMBOLDEN
Official Title
GORE® Embolic Filter in Carotid Stenting for High Risk Surgical Subjects (GORE EMBOLDEN)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
W.L.Gore & Associates
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carotid Artery Stenosis
Keywords
carotid artery stenosis, embolic protection device, distal embolic filter, minimizing risks of carotid artery stenting
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
250 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GORE® Embolic Filter
Arm Type
Experimental
Arm Description
Subjects treated with the GORE® Embolic Filter and an FDA-approved carotid stent.
Intervention Type
Device
Intervention Name(s)
GORE® Embolic Filter
Intervention Description
Embolic protection during carotid stenting
Primary Outcome Measure Information:
Title
Composite Major Adverse Event (MAE) Rate of Death, Myocardial Infarction, and Stroke at 30 Days Postprocedure
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Device Success
Description
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).
Time Frame
Post Procedure
Title
Clinical Success
Description
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.
Time Frame
30 days
Title
Access Site Complications
Description
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.
Time Frame
30 days
Title
Neurologic Events
Description
Neurological Events at 30 days post-procedure, including transient ischemic attacks (TIAs).
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William A. Gray, MD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
GORE® Embolic Filter in Carotid Stenting for High Risk Surgical Subjects (EMBOLDEN)
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