Carotid Revascularization With ev3 Arterial Technology Evolution (CREATE) Trial
CREATE
1 other identifier
interventional
419
1 country
31
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Apr 2004
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2005
CompletedFirst Submitted
Initial submission to the registry
February 7, 2008
CompletedFirst Posted
Study publicly available on registry
February 21, 2008
CompletedMay 14, 2021
December 1, 2008
February 7, 2008
May 12, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
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
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
Interventions
Carotid artery stenting with distal embolic protection.
Eligibility Criteria
You may qualify if:
- years and above
- informed consent
- for female subjects, not pregnant or planning on becoming pregnant
- meet protocol defined anatomical or clinical high risk criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (31)
Banner Baywood Heart Hospital
Mesa, Arizona, 85205, United States
Scripps Memorial Hospital
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
Related Publications (2)
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.
PMID: 16781363RESULTSafian 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.
PMID: 15343559RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert Safian, MD
Corewell Health East
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 7, 2008
First Posted
February 21, 2008
Study Start
April 1, 2004
Study Completion
October 1, 2005
Last Updated
May 14, 2021
Record last verified: 2008-12