Carotid Revascularization With ev3 Arterial Technology Evolution (CREATE) Trial

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)

Interventions

  • Device: PROTÉGÉ® GPS™ and PROTÉGÉ® RX Carotid Stent Systems and Spider Embolic Protection Device
    • Carotid artery stenting with distal embolic protection.

Clinical Trial Outcome Measures

Primary 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

Secondary 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
  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Medtronic Endovascular
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Robert Safian, MD, Principal Investigator, William Beaumont Hospitals

Citations Reporting on Results

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.

Safian 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.

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