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Carotid Revascularization With ev3 Arterial Technology Evolution (CREATE) Trial

This study has been completed.
Sponsor:
Information provided by:
ev3
ClinicalTrials.gov Identifier:
NCT00619775
First received: February 7, 2008
Last updated: December 5, 2008
Last verified: December 2008
History of Changes
  Purpose

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.


Condition Intervention Phase
Carotid Artery Disease
 Device: PROTÉGÉ® GPS™ and PROTÉGÉ® RX Carotid Stent Systems and Spider Embolic Protection Device
 Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Carotid Revascularization With ev3 Arterial Technology Evolution (CREATE) Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by ev3:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • Target lesion revascularization [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Target vessel revascularization [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Primary patency at one year (<70% stenosis as measured by duplex scan) [ Time Frame: one year ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 419
Study Start Date: April 2004
Study Completion Date: October 2005
Intervention Details:
    Device: PROTÉGÉ® GPS™ and PROTÉGÉ® RX Carotid Stent Systems and Spider Embolic Protection Device
    Carotid artery stenting with distal embolic protection.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00619775

  Show 31 Study Locations
Sponsors and Collaborators
ev3
Investigators
Principal Investigator: Robert Safian, MD William Beaumont Hospitals
  More Information

Publications:

Responsible Party: Robert Safian, MD, William Beaumont Hospital
ClinicalTrials.gov Identifier: NCT00619775     History of Changes
Other Study ID Numbers: P-1007
Study First Received: February 7, 2008
Last Updated: December 5, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by ev3:
Carotid Artery Disease
Embolic Protection

Additional relevant MeSH terms:
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 19, 2013