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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014