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The objective of this study is to provide an ongoing evaluation of clinical outcomes associated with the GORE Flow Reversal System and the GORE Embolic Filter when used for embolic protection during carotid artery stenting.
Physicians will have the opportunity to select which embolic protection device, the GORE Flow Reversal System or the GORE Embolic Filter, to use during the carotid artery stenting procedure.
This study is not designed to compare study endpoints between the two treatment arms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GFRS EPD | Other | Carotid artery stenting with Gore Flow Reversal System embolic protection device |
|
| GEF EPD | Other | Carotid artery stenting with Gore Embolic Filter embolic protection device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gore Flow Reversal System | Device | Embolic protection by the GORE Flow Reversal System during carotid artery angioplasty and stenting |
|
| Measure | Description | Time Frame |
|---|---|---|
| Major Adverse Events (MAE) | Major Adverse Events include death, stroke and myocardial infarction | Onset from start of index procedure to 30-day follow-up assessment |
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Inclusion Criteria:
Exclusion Criteria:
If the patient is contraindicated for both arms (devices) they may not be enrolled.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| W.L. Gore and Associates, Inc | Flagstaff | Arizona | 86001 | United States | ||
| Hoag Memorial Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | GFRS EPD | Carotid artery stenting with Gore Flow Reversal System Gore Flow Reversal System: Embolic protection by the GORE Flow Reversal System during carotid artery angioplasty and stenting |
| FG001 | GEF EPD |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Gore Embolic Filter | Device | Embolic protection by the GORE Embolic Filter during carotid artery angioplasty and stenting |
|
|
| Newport Beach |
| California |
| 92663 |
| United States |
| University of California San Francisco | San Francisco | California | 94143 | United States |
| First Coast Cardiovascular Institute | Jacksonville | Florida | 32216 | United States |
| Emory University | Atlanta | Georgia | 30322 | United States |
| Kaiser FOundation Hospitals | Honolulu | Hawaii | 96819 | United States |
| Heart Care Research Foundation | Mokena | Illinois | 60488 | United States |
| Rockford Cardiovascular Associates | Rockford | Illinois | 61107 | United States |
| Indiana University | Indianapolis | Indiana | 46202 | United States |
| Ochsner Clinic | New Orleans | Louisiana | 70121 | United States |
| Johns Hopkins Hospital | Baltimore | Maryland | 21205 | United States |
| Beth Israel Decaoness Medical Center | Boston | Massachusetts | 02215 | United States |
| Harper Hospital | Detroit | Michigan | 48201 | United States |
| St John's Medical Center | Detroit | Michigan | 48236 | United States |
| St Joseph Mercy Hospital | Pontiac | Michigan | 48341 | United States |
| Covenant Medical Center | Saginaw | Michigan | 48602 | United States |
| St Anthony's Medical Center | St Louis | Missouri | 63128 | United States |
| St Joesph's Medical Center | St Louis | Missouri | 64114 | United States |
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| Cooper University Hospital | Camden | New Jersey | 08103 | United States |
| Mercy Hospital | Buffalo | New York | 14220 | United States |
| Mt Sinai Hospital | New York | New York | 10029 | United States |
| St Francis Hospital | Roslyn | New York | 11576 | United States |
| Wake Heart Research | Raleigh | North Carolina | 26610 | United States |
| Forsyth Memorial Hospital | Winston-Salem | North Carolina | 27103 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Riverside Methodist Hospital | Columbus | Ohio | 43214 | United States |
| Southwest General Health Center | Middleburg Heights | Ohio | 44130 | United States |
| Heritage Valley Health Network | Beaver | Pennsylvania | 15009 | United States |
| Spirit Physician Services / Capital Cardiovascular Assoc | Camp Hill | Pennsylvania | 17011 | United States |
| Drexel University | Philadelphia | Pennsylvania | 19102 | United States |
| York Hospital | York | Pennsylvania | 17405 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Rapid City Regional Hospital | Rapid City | South Dakota | 57701 | United States |
| N. Central Heart Hospital | Sioux Falls | South Dakota | 57108 | United States |
| St Luke's Episcopal | Houston | Texas | 77030 | United States |
| Appleton Medical Cetner | Appleton | Wisconsin | 54911 | United States |
| University of Wisconsin | Madison | Wisconsin | 53792 | United States |
| St Lukes Medical Center | Milwaukee | Wisconsin | 53215 | United States |
Carotid artery stenting with Gore Embolic Filter
Gore Embolic Filter: Embolic protection by the GORE Embolic Filter during carotid artery angioplasty and stenting
| COMPLETED |
|
| NOT COMPLETED |
|
All Enrolled Subjects
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| ID | Title | Description |
|---|---|---|
| BG000 | GFRS EPD | Carotid artery stenting with Gore Flow Reversal System Gore Flow Reversal System: Embolic protection by the GORE Flow Reversal System during carotid artery angioplasty and stenting |
| BG001 | GEF EPD | Carotid artery stenting with Gore Embolic Filter Gore Embolic Filter: Embolic protection by the GORE Embolic Filter during carotid artery angioplasty and stenting |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | This measure is structured as a "check all that apply" field on the Case Report Form. Thus, the race categories are not mutually exclusive, except that "Not Reported" is mutually exclusive with the others. Because of this, the sum of the individual category counts is greater than the overall number of participants. | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Major Adverse Events (MAE) | Major Adverse Events include death, stroke and myocardial infarction | Enrolled subjects with successful procedure and sufficient follow-up | Posted | Number | participants | Onset from start of index procedure to 30-day follow-up assessment |
|
|
|
30-day visit window
The Major Adverse Event components are reported as individual Serious Adverse Events. No other adverse events were collected in this study, so the number of subjects affected by Other (Not Including Serious) Adverse Events is zero (0).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | GFRS EPD | Carotid artery stenting with Gore Flow Reversal System Gore Flow Reversal System: Embolic protection by the GORE Flow Reversal System during carotid artery angioplasty and stenting | 18 | 425 | 0 | 425 | ||
| EG001 | GEF EPD | Carotid artery stenting with Gore Embolic Filter Gore Embolic Filter: Embolic protection by the GORE Embolic Filter during carotid artery angioplasty and stenting | 36 | 972 | 0 | 972 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| All Cause Death | Cardiac disorders | Non-systematic Assessment |
| ||
| Myocardial Infarction | Cardiac disorders | Non-systematic Assessment |
| ||
| Stroke | Nervous system disorders | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bryan Randall, Clinical Biostatistician | W. L. Gore & Associates | 928-864-4832 | BRandall@WLGore.com |
| ID | Term |
|---|---|
| D016893 | Carotid Stenosis |
| D003251 | Constriction, Pathologic |
| D002340 | Carotid Artery Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D020763 | Pathological Conditions, Anatomical |
| ID | Term |
|---|---|
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D057505 | Embolic Protection Devices |
| ID | Term |
|---|---|
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
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| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Black or African American |
|
| Native Hawaiian or Other Pacific Islander |
|
| White or Caucasian |
|
| Not Reported |
|