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Completed

NCT Number: NCT00619775

Carotid Revascularization With ev3 Arterial Technology Evolution (CREATE) Trial

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.

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Key information

Conditions

Carotid Artery Disease Brain Diseases Cardiovascular Diseases Carotid Artery Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Banner Baywood Heart Hospital, Mesa, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PROTÉGÉ® GPS™ and PROTÉGÉ® RX Carotid Stent Systems and Spider Embolic Protection Device

Device

Carotid artery stenting with distal embolic protection.

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

    Time frame: 30 days and one year

Secondary outcomes

  1. 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

  2. Target lesion revascularization

    Time frame: one year

  3. Target vessel revascularization

    Time frame: one year

  4. Primary patency at one year (<70% stenosis as measured by duplex scan)

    Time frame: one year

  5. 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

Sponsors and collaborators

Lead sponsor

Medtronic Endovascular

Industry

Registry information

Acronym: CREATE

Important dates

Study start
2004
Study completion
2005
First posted
Feb 21, 2008
Registry last updated
May 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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