Carotid Revascularization With ev3 Arterial Technology Evolution (CREATE) Trial
- Conditions
- Carotid Artery Disease
- Registration Number
- NCT00619775
- Lead Sponsor
- Medtronic Endovascular
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 419
- 18 years and above
- informed consent
- for female subjects, not pregnant or planning on becoming pregnant
- meet protocol defined anatomical or clinical high risk criteria
- participation in another clincial study which may affect either the pre-procedure or follow-up results
- prior stenting of the ipsilateral carotid artery
- life expectancy less than twelve months
- known allergy or intolerance of study medications or device materials
- must not meet general or angiographic exclusion criteria as defined in the protocol
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method 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 vessel revascularization one year Target lesion 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
Trial Locations
- Locations (31)
William Beaumont Hospital
🇺🇸Royal Oak, Michigan, United States
Salinas Valley Memorial Healthcare System
🇺🇸Salinas, California, United States
St. Francis Medical Center
🇺🇸Peoria, Illinois, United States
Oakwood Hospital
🇺🇸Dearborn, Michigan, United States
Baptist Heart Institute
🇺🇸Knoxville, Tennessee, United States
Terrebonne General Hospital
🇺🇸Houma, Louisiana, United States
Hoag Memorial Hospital
🇺🇸Newport Beach, California, United States
Scripps Memorial Hospital
🇺🇸La Jolla, California, United States
Pinnacle Health at Harrisburg Hospital
🇺🇸Wormleysburg, Pennsylvania, United States
St. Louis University Medical Center
🇺🇸Saint Louis, Missouri, United States
University of Buffalo Millard Fillmore Hospital
🇺🇸Buffalo, New York, United States
Greenville Hospital System
🇺🇸Greenville, South Carolina, United States
Southwest Medical Center
🇺🇸Lafayette, Louisiana, United States
Union Memorial Hospital
🇺🇸Baltimore, Maryland, United States
Hahnemann University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Riverside Methodist
🇺🇸Columbus, Ohio, United States
Allegheny General Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Banner Baywood Heart Hospital
🇺🇸Mesa, Arizona, United States
El Camino Hospital
🇺🇸Mountain View, California, United States
Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
Kramer & Crouse Cardiology
🇺🇸Shawnee Mission, Kansas, United States
Wake Heart Associates
🇺🇸Raleigh, North Carolina, United States
Duke University Medical Center
🇺🇸Raleigh, North Carolina, United States
Holy Spirit Hospital
🇺🇸Harrisburg, Pennsylvania, United States
Avera Heart Hospital of South Dakota
🇺🇸Sioux Falls, South Dakota, United States
University of Virginia
🇺🇸Charlottesville, Virginia, United States
St. Vincent Hospital & Health Care Centers
🇺🇸Indianapolis, Indiana, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
The Heart Center of Indiana
🇺🇸Indianapolis, Indiana, United States
Swedish Medical Center
🇺🇸Seattle, Washington, United States
Washington Adventist Hospital
🇺🇸Takoma Park, Maryland, United States