Carotid Revascularization With ev3 Arterial Technology Evolution Post Approval Study
CREATE PAS
1 other identifier
interventional
1,500
1 country
2
Brief 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.To evaluate the physician level of experience with carotid artery stenting procedures with adverse event rates.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2007
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2007
CompletedFirst Submitted
Initial submission to the registry
September 14, 2007
CompletedFirst Posted
Study publicly available on registry
September 17, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2014
CompletedResults Posted
Study results publicly available
September 16, 2015
CompletedMarch 5, 2019
February 1, 2019
6.7 years
September 14, 2007
July 28, 2015
February 14, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
30 Days
Study Arms (1)
Device
EXPERIMENTALDevice
Interventions
Carotid artery stenting with distal embolic protection.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Subjects with contraindications as outlined in the Instructions for Use
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Stony Brook University Hospital
Stony Brook, New York, United States
Wellmont Medical Center
Kingsport, Tennessee, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Stephanie Cihlar
- Organization
- Medtronic
Study Officials
- PRINCIPAL INVESTIGATOR
Gary Ansel, MD
MidWest Cardiology Research Foundation
- PRINCIPAL INVESTIGATOR
Robert Safian, MD
Corewell Health East
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 14, 2007
First Posted
September 17, 2007
Study Start
May 1, 2007
Primary Completion
January 1, 2014
Study Completion
January 1, 2014
Last Updated
March 5, 2019
Results First Posted
September 16, 2015
Record last verified: 2019-02