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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
419

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2004

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2005

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 7, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 7, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 21, 2008

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 14, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 12, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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