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Carotid Revascularization With ev3 Arterial Technology Evolution (CREATE) Trial (CREATE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00619775
Recruitment Status : Completed
First Posted : February 21, 2008
Last Update Posted : May 14, 2021
Sponsor:
Information provided by (Responsible Party):
Medtronic Endovascular

Tracking Information
First Submitted Date  ICMJE February 7, 2008
First Posted Date  ICMJE February 21, 2008
Last Update Posted Date May 14, 2021
Study Start Date  ICMJE April 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: February 7, 2008)
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 [ Time Frame: 30 days and one year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 7, 2008)
  • Ipsilateral CVA, procedure-related contralateral CVA or death with 30 days of implantation; and ipsilateral CVA from 31 days to 1 year post-implantation [ Time Frame: 30 days and one year ]
  • Target lesion revascularization [ Time Frame: one year ]
  • Target vessel revascularization [ Time Frame: one year ]
  • Primary patency at one year (<70% stenosis as measured by duplex scan) [ Time Frame: 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%) [ Time Frame: at implant ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Carotid Revascularization With ev3 Arterial Technology Evolution (CREATE) Trial
Official Title  ICMJE Carotid Revascularization With ev3 Arterial Technology Evolution (CREATE) Trial
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Carotid Artery Disease
Intervention  ICMJE Device: PROTÉGÉ® GPS™ and PROTÉGÉ® RX Carotid Stent Systems and Spider Embolic Protection Device
Carotid artery stenting with distal embolic protection.
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 7, 2008)
419
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00619775
Other Study ID Numbers  ICMJE P-1007
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Medtronic Endovascular
Study Sponsor  ICMJE Medtronic Endovascular
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Robert Safian, MD William Beaumont Hospitals
PRS Account Medtronic Endovascular
Verification Date December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP