Carotid Revascularization With ev3 Arterial Technology Evolution (CREATE) Trial
NCT ID: NCT00619775
Last Updated: 2021-05-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
419 participants
INTERVENTIONAL
2004-04-30
2005-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Interventions
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PROTÉGÉ® GPS™ and PROTÉGÉ® RX Carotid Stent Systems and Spider Embolic Protection Device
Carotid artery stenting with distal embolic protection.
Eligibility Criteria
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Inclusion Criteria
* informed consent
* for female subjects, not pregnant or planning on becoming pregnant
* meet protocol defined anatomical or clinical high risk criteria
Exclusion Criteria
* prior stenting of the ipsilateral carotid artery
* life expectancy less than twelve months
* known allergy or intolerance of study medications or device materials
18 Years
ALL
No
Sponsors
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Medtronic Endovascular
INDUSTRY
Responsible Party
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Principal Investigators
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Robert Safian, MD
Role: PRINCIPAL_INVESTIGATOR
William Beaumont Hospitals
Locations
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Banner Baywood Heart Hospital
Mesa, Arizona, United States
Scripps Memorial Hospital
La Jolla, California, United States
El Camino Hospital
Mountain View, California, United States
Hoag Memorial Hospital
Newport Beach, California, United States
Salinas Valley Memorial Healthcare System
Salinas, California, United States
Washington Hospital Center
Washington D.C., District of Columbia, United States
St. Francis Medical Center
Peoria, Illinois, United States
St. Vincent Hospital & Health Care Centers
Indianapolis, Indiana, United States
The Heart Center of Indiana
Indianapolis, Indiana, United States
Kramer & Crouse Cardiology
Shawnee Mission, Kansas, United States
Terrebonne General Hospital
Houma, Louisiana, United States
Southwest Medical Center
Lafayette, Louisiana, United States
Union Memorial Hospital
Baltimore, Maryland, United States
Washington Adventist Hospital
Takoma Park, Maryland, United States
Oakwood Hospital
Dearborn, Michigan, United States
William Beaumont Hospital
Royal Oak, Michigan, United States
St. Louis University Medical Center
St Louis, Missouri, United States
University of Buffalo Millard Fillmore Hospital
Buffalo, New York, United States
Duke University Medical Center
Raleigh, North Carolina, United States
Wake Heart Associates
Raleigh, North Carolina, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Riverside Methodist
Columbus, Ohio, United States
Holy Spirit Hospital
Harrisburg, Pennsylvania, United States
Hahnemann University Hospital
Philadelphia, Pennsylvania, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
Pinnacle Health at Harrisburg Hospital
Wormleysburg, Pennsylvania, United States
Greenville Hospital System
Greenville, South Carolina, United States
Avera Heart Hospital of South Dakota
Sioux Falls, South Dakota, United States
Baptist Heart Institute
Knoxville, Tennessee, United States
University of Virginia
Charlottesville, Virginia, United States
Swedish Medical Center
Seattle, Washington, United States
Countries
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References
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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.
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.
Other Identifiers
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P-1007
Identifier Type: -
Identifier Source: org_study_id
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