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Evaluate the safety and efficacy of the Protege Stent and Spider Device in the treatment of common and/or internal carotid artery stenoses for subjects that are high risk for carotid endarterectomy.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PROTÉGÉ® GPS™ and PROTÉGÉ® RX Carotid Stent Systems and Spider Embolic Protection Device | Device | Carotid artery stenting with distal embolic protection. |
| Measure | Description | Time Frame |
|---|---|---|
| Myocardial infarction, ipsilateral cerebrovascular accident, procedure-related contralateral CVA or death within 30 days of implantation; and ipsilateral CVA from 31 days to 1 year post-implantation | 30 days and one year |
| Measure | Description | Time Frame |
|---|---|---|
| Ipsilateral CVA, procedure-related contralateral CVA or death with 30 days of implantation; and ipsilateral CVA from 31 days to 1 year post-implantation | 30 days and one year | |
| Target lesion revascularization | one year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Safian, MD | Corewell Health East | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner Baywood Heart Hospital | Mesa | Arizona | 85205 | United States | ||
| Scripps Memorial Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16781363 | Result | Safian RD, Bresnahan JF, Jaff MR, Foster M, Bacharach JM, Maini B, Turco M, Myla S, Eles G, Ansel GM; CREATE Pivotal Trial Investigators. Protected carotid stenting in high-risk patients with severe carotid artery stenosis. J Am Coll Cardiol. 2006 Jun 20;47(12):2384-9. doi: 10.1016/j.jacc.2005.12.076. | |
| 15343559 | Result |
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| Target vessel revascularization | one year |
| Primary patency at one year (<70% stenosis as measured by duplex scan) | one year |
| Technical success (defined as the ability to deploy the filter, place the stent over the filter wire, and recapture the filter with the resulting residual stenosis <50%) | at implant |
| La Jolla |
| California |
| 92037 |
| United States |
| El Camino Hospital | Mountain View | California | 94040 | United States |
| Hoag Memorial Hospital | Newport Beach | California | 92663 | United States |
| Salinas Valley Memorial Healthcare System | Salinas | California | 93901 | United States |
| Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | United States |
| St. Francis Medical Center | Peoria | Illinois | 61637 | United States |
| St. Vincent Hospital & Health Care Centers | Indianapolis | Indiana | 46260 | United States |
| The Heart Center of Indiana | Indianapolis | Indiana | 46290 | United States |
| Kramer & Crouse Cardiology | Shawnee Mission | Kansas | 66204 | United States |
| Terrebonne General Hospital | Houma | Louisiana | 70360 | United States |
| Southwest Medical Center | Lafayette | Louisiana | 70506 | United States |
| Union Memorial Hospital | Baltimore | Maryland | 21218 | United States |
| Washington Adventist Hospital | Takoma Park | Maryland | 20912 | United States |
| Oakwood Hospital | Dearborn | Michigan | 48124 | United States |
| William Beaumont Hospital | Royal Oak | Michigan | 48073 | United States |
| St. Louis University Medical Center | St Louis | Missouri | 63110 | United States |
| University of Buffalo Millard Fillmore Hospital | Buffalo | New York | 14209 | United States |
| Duke University Medical Center | Raleigh | North Carolina | 27609 | United States |
| Wake Heart Associates | Raleigh | North Carolina | 27610 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44111 | United States |
| Riverside Methodist | Columbus | Ohio | 43214 | United States |
| Holy Spirit Hospital | Harrisburg | Pennsylvania | 17110 | United States |
| Hahnemann University Hospital | Philadelphia | Pennsylvania | 19102 | United States |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | United States |
| Pinnacle Health at Harrisburg Hospital | Wormleysburg | Pennsylvania | 17043 | United States |
| Greenville Hospital System | Greenville | South Carolina | 29605 | United States |
| Avera Heart Hospital of South Dakota | Sioux Falls | South Dakota | 57108 | United States |
| Baptist Heart Institute | Knoxville | Tennessee | 37920 | United States |
| University of Virginia | Charlottesville | Virginia | 22908 | United States |
| Swedish Medical Center | Seattle | Washington | 98122 | United States |
| Safian RD, Bacharach JM, Ansel GM, Criado FJ. Carotid stenting with a new system for distal embolic protection and stenting in high-risk patients: the carotid revascularization with ev3 arterial technology evolution (CREATE) feasibility trial. Catheter Cardiovasc Interv. 2004 Sep;63(1):1-6. doi: 10.1002/ccd.20155. |
| ID | Term |
|---|---|
| D002340 | Carotid Artery Diseases |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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