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

May 12, 2021 updated by: Medtronic Endovascular
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

419

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Mesa, Arizona, United States, 85205
        • Banner Baywood Heart Hospital
    • California
      • La Jolla, California, United States, 92037
        • Scripps Memorial Hospital
      • Mountain View, California, United States, 94040
        • El Camino Hospital
      • Newport Beach, California, United States, 92663
        • Hoag Memorial Hospital
      • Salinas, California, United States, 93901
        • Salinas Valley Memorial Healthcare System
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Washington Hospital Center
    • Illinois
      • Peoria, Illinois, United States, 61637
        • St. Francis Medical Center
    • Indiana
      • Indianapolis, Indiana, United States, 46290
        • The Heart Center of Indiana
      • Indianapolis, Indiana, United States, 46260
        • St. Vincent Hospital & Health Care Centers
    • Kansas
      • Shawnee Mission, Kansas, United States, 66204
        • Kramer & Crouse Cardiology
    • Louisiana
      • Houma, Louisiana, United States, 70360
        • Terrebonne General Hospital
      • Lafayette, Louisiana, United States, 70506
        • Southwest Medical Center
    • Maryland
      • Baltimore, Maryland, United States, 21218
        • Union Memorial Hospital
      • Takoma Park, Maryland, United States, 20912
        • Washington Adventist Hospital
    • Michigan
      • Dearborn, Michigan, United States, 48124
        • Oakwood Hospital
      • Royal Oak, Michigan, United States, 48073
        • William Beaumont Hospital
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • St. Louis University Medical Center
    • New York
      • Buffalo, New York, United States, 14209
        • University of Buffalo Millard Fillmore Hospital
    • North Carolina
      • Raleigh, North Carolina, United States, 27609
        • Duke University Medical Center
      • Raleigh, North Carolina, United States, 27610
        • Wake Heart Associates
    • Ohio
      • Cleveland, Ohio, United States, 44111
        • Cleveland Clinic Foundation
      • Columbus, Ohio, United States, 43214
        • Riverside Methodist
    • Pennsylvania
      • Harrisburg, Pennsylvania, United States, 17110
        • Holy Spirit Hospital
      • Philadelphia, Pennsylvania, United States, 19102
        • Hahnemann University Hospital
      • Pittsburgh, Pennsylvania, United States, 15212
        • Allegheny General Hospital
      • Wormleysburg, Pennsylvania, United States, 17043
        • Pinnacle Health at Harrisburg Hospital
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Greenville Hospital System
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57108
        • Avera Heart Hospital of South Dakota
    • Tennessee
      • Knoxville, Tennessee, United States, 37920
        • Baptist Heart Institute
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia
    • Washington
      • Seattle, Washington, United States, 98122
        • Swedish Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
30 days and one year

Secondary Outcome Measures

Outcome Measure
Time Frame
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
30 days and one year
Target lesion revascularization
Time Frame: one year
one year
Target vessel revascularization
Time Frame: one year
one year
Primary patency at one year (<70% stenosis as measured by duplex scan)
Time Frame: one year
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
at implant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Endovascular

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2004

Study Completion (Actual)

October 1, 2005

Study Registration Dates

First Submitted

February 7, 2008

First Submitted That Met QC Criteria

February 7, 2008

First Posted (Estimate)

February 21, 2008

Study Record Updates

Last Update Posted (Actual)

May 14, 2021

Last Update Submitted That Met QC Criteria

May 12, 2021

Last Verified

December 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P-1007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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