Carotid Artery DiseasePhase 3CREATENCT00619775
Carotid Revascularization With ev3 Arterial Technology Evolution (CREATE) Trial
A Phase 3 study testing PROTÉGÉ® GPS™ and PROTÉGÉ® RX Carotid Stent Systems and Spider Embolic Protection Device in people with Carotid Artery Disease, run by Medtronic Endovascular at 31 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carotid Artery Disease
- What is being tested?
- PROTÉGÉ® GPS™ and PROTÉGÉ® RX Carotid Stent Systems and Spider Embolic Protection Device
- Type of treatment
- Medical device
- How many people
- 419 participants
- Where
- 31 sitesUnited States
- Study dates
- Apr 2004to Oct 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
31 sites in 1 country.
31 sites in 1 country
United States31 sites
Union Memorial Hospital
Baltimore, Maryland, 21218
University of Buffalo Millard Fillmore Hospital
Buffalo, New York, 14209
University of Virginia
Charlottesville, Virginia, 22908
Cleveland Clinic Foundation
Cleveland, Ohio, 44111
Riverside Methodist
Columbus, Ohio, 43214
Oakwood Hospital
Dearborn, Michigan, 48124
Greenville Hospital System
Greenville, South Carolina, 29605
Holy Spirit Hospital
Harrisburg, Pennsylvania, 17110
Terrebonne General Hospital
Houma, Louisiana, 70360
St. Vincent Hospital & Health Care Centers
Indianapolis, Indiana, 46260
The Heart Center of Indiana
Indianapolis, Indiana, 46290
Baptist Heart Institute
Knoxville, Tennessee, 37920
Scripps Memorial Hospital
La Jolla, California, 92037
Southwest Medical Center
Lafayette, Louisiana, 70506
Banner Baywood Heart Hospital
Mesa, Arizona, 85205
El Camino Hospital
Mountain View, California, 94040
Hoag Memorial Hospital
Newport Beach, California, 92663
St. Francis Medical Center
Peoria, Illinois, 61637
Hahnemann University Hospital
Philadelphia, Pennsylvania, 19102
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
Duke University Medical Center
Raleigh, North Carolina, 27609
Wake Heart Associates
Raleigh, North Carolina, 27610
William Beaumont Hospital
Royal Oak, Michigan, 48073
Salinas Valley Memorial Healthcare System
Salinas, California, 93901
Swedish Medical Center
Seattle, Washington, 98122
Kramer & Crouse Cardiology
Shawnee Mission, Kansas, 66204
Avera Heart Hospital of South Dakota
Sioux Falls, South Dakota, 57108
St. Louis University Medical Center
St Louis, Missouri, 63110
Washington Adventist Hospital
Takoma Park, Maryland, 20912
Washington Hospital Center
Washington D.C., District of Columbia, 20010
Pinnacle Health at Harrisburg Hospital
Wormleysburg, Pennsylvania, 17043
About this study
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.
- Conditions
- Carotid Artery Disease
- Being tested
- PROTÉGÉ® GPS™ and PROTÉGÉ® RX Carotid Stent Systems and Spider Embolic Protection Device
- Keywords
- Carotid Artery Disease, Embolic Protection
- Medical subject headings
- Carotid Artery Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PROTÉGÉ® GPS™ and PROTÉGÉ® RX Carotid Stent Systems and Spider Embolic Protection DeviceDevice
Carotid artery stenting with distal embolic protection.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 days and one year
Secondary outcomes (5)
Ipsilateral CVA, procedure-related contralateral CVA or death with 30 days of implantation; and ipsilateral CVA from 31 days to 1 year post-implantation
Measured: 30 days and one year
Target lesion revascularization
Measured: one year
Target vessel revascularization
Measured: one year
Primary patency at one year (<70% stenosis as measured by duplex scan)
Measured: 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%)
Measured: at implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2008 (estimated)
- Study startApr 2004
- Study completionOct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Carotid Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 419 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Endovascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Safian, MD, Principal investigator, Corewell Health East
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00619775
- Sponsor's protocol ID
- P-1007
- Acronym
- CREATE
- Status last verified
- Dec 2008
- First submitted
- 7 Feb 2008
- Last updated
- 14 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 16781363Safian 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.
PubMed 15343559
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carotid Revascularization With ev3 Arterial Technology Evolution (CREATE) Trial
- ClinicalTrials.gov ID
- NCT00619775
- Acronym / sponsor ID
- CREATE / P-1007
- Conditions
- Carotid Artery Disease
- Keywords
- Carotid Artery Disease, Embolic Protection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 419 participants (actual)
- Lead sponsor
- Medtronic EndovascularIndustry (pharma, biotech, devices)
- Study start
- Apr 2004
- Study completion
- Oct 2005 (actual)
- First posted
- 21 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PROTÉGÉ® GPS™ and PROTÉGÉ® RX Carotid Stent Systems and Spider Embolic Protection DeviceCarotid artery stenting with distal embolic protection. | Device | – |
Primary outcome
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
5 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2021.
- Results publication: PubMed 16781363Safian 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.
- Results publication: PubMed 15343559Safian 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Safian, MD principal investigator
Corewell Health East
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PROTÉGÉ® GPS™ and PROTÉGÉ® RX Carotid Stent Systems and Spider Embolic Protection Device in people with Carotid Artery Disease, run by Medtronic Endovascular at 31 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00619775, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2021; AzTrials last refreshed its copy on 26 Oct 2026.