Carotid Artery DiseaseCREATE PASNCT00530504
Carotid Revascularization With ev3 Arterial Technology Evolution Post Approval Study
A study testing PROTÉGÉ™ GPS™ and PROTÉGÉ™ RX Carotid Stent Systems and SpiderFX™ Embolic Protection Device in people with Carotid Artery Disease, run by Medtronic Endovascular at 2 sites in United States.
Trial summary
The purposes of this study are: 1. To provide additional safety and effectiveness information on the commercial use of Protégé™ GPS™ and Protégé™ RX Carotid Stent Systems and the SpiderFX™ Embolic Protection Device. 2. To evaluate rare and unanticipated adverse events. 3. 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 SpiderFX™ Embolic Protection Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2007to Jan 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Intent to use the PROTÉGÉ™ GPS™ and PROTÉGÉ™ RX and SpiderFX™ to treat carotid artery disease per Instructions for Use
- Meet Instruction for Use (IFU)/ Centers for Medicare \& Medicaid Services (CMS)defined anatomical or clinical high risk criteria
Who cannot join
- Subjects with contraindications as outlined in the Instructions for Use
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Wellmont Medical Center
Kingsport, Tennessee
Stony Brook University Hospital
Stony Brook, New York
About this study
The purposes of this study are:
- To provide additional safety and effectiveness information on the commercial use of Protégé™ GPS™ and Protégé™ RX Carotid Stent Systems and the SpiderFX™ Embolic Protection Device.
- To evaluate rare and unanticipated adverse events.
- To evaluate the physician level of experience with carotid artery stenting procedures with adverse event rates.
- Conditions
- Carotid Artery Disease
- Being tested
- PROTÉGÉ™ GPS™ and PROTÉGÉ™ RX Carotid Stent Systems and SpiderFX™ 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 SpiderFX™ Embolic Protection DeviceDevice
Carotid artery stenting with distal embolic protection.
| Study group | Role | What they receive |
|---|---|---|
| Device | Experimental | Device Receives: Device: PROTÉGÉ™ GPS™ and PROTÉGÉ™ RX Carotid Stent Systems and SpiderFX™ Embolic Protection Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Rate of Death, Ipsilateral CVA, Procedure-related CVA, or Myocardial Infarction (MI) at 30 Days Post-procedure.
Combined incidence of Major Adverse Cardiac and Cerebrovascular Events (MACCE) defined as myocardial infarction (MI), ipsilateral cerebrovascular accident (CVA), procedure-related contralateral CVA, or death, within 30 days of implantation.
Measured: 30 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2007 (estimated)
- Study startMay 2007
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Endovascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gary Ansel, MD, Principal investigator, MidWest Cardiology Research FoundationRobert Safian, MD, Principal investigator, Corewell Health East
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00530504
- Sponsor's protocol ID
- P-2611
- Acronym
- CREATE PAS
- Status last verified
- Feb 2019
- First submitted
- 14 Sep 2007
- Last updated
- 5 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carotid Revascularization With ev3 Arterial Technology Evolution Post Approval Study
- ClinicalTrials.gov ID
- NCT00530504
- Acronym / sponsor ID
- CREATE PAS / P-2611
- Conditions
- Carotid Artery Disease
- Keywords
- Carotid Artery Disease, Embolic Protection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- Medtronic EndovascularIndustry (pharma, biotech, devices)
- Study start
- May 2007
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 17 Sep 2007 (estimated)
- Results
- Posted 16 Sep 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purposes of this study are:
- To provide additional safety and effectiveness information on the commercial use of Protégé™ GPS™ and Protégé™ RX Carotid Stent Systems and the SpiderFX™ Embolic Protection Device.
- To evaluate rare and unanticipated adverse events.
- To evaluate the physician level of experience with carotid artery stenting procedures with adverse event rates.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Device | Experimental | Device: PROTÉGÉ™ GPS™ and PROTÉGÉ™ RX Carotid Stent Systems and SpiderFX™ Embolic Protection DeviceDevice |
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
- Intent to use the PROTÉGÉ™ GPS™ and PROTÉGÉ™ RX and SpiderFX™ to treat carotid artery disease per Instructions for Use
- Meet Instruction for Use (IFU)/ Centers for Medicare \& Medicaid Services (CMS)defined anatomical or clinical high risk criteria
Key exclusion criteria (1 listed)
- Subjects with contraindications as outlined in the Instructions for Use
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 SpiderFX™ Embolic Protection DeviceCarotid artery stenting with distal embolic protection. | Device | Device |
Primary outcome
Composite Rate of Death, Ipsilateral CVA, Procedure-related CVA, or Myocardial Infarction (MI) at 30 Days Post-procedure.
Time frame: 30 Days
Combined incidence of Major Adverse Cardiac and Cerebrovascular Events (MACCE) defined as myocardial infarction (MI), ipsilateral cerebrovascular accident (CVA), procedure-related contralateral CVA, or death, within 30 days of implantation.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Click here for information on ev3 Endovascular Inc.Link provided by the sponsor.
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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.
Gary Ansel, MD principal investigator
MidWest Cardiology Research Foundation
Robert Safian, MD principal investigator
Corewell Health East
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PROTÉGÉ™ GPS™ and PROTÉGÉ™ RX Carotid Stent Systems and SpiderFX™ Embolic Protection Device in people with Carotid Artery Disease, run by Medtronic Endovascular at 2 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 1 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 5 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Sep 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Composite Rate of Death, Ipsilateral CVA, Procedure-related CVA, or Myocardial Infarction (MI) at 30 Days Post-procedure. (time frame: 30 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Mar 2019.