Carotid Revascularization With ev3 Arterial Technology Evolution Post Approval Study (CREATE PAS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00530504|
Recruitment Status : Completed
First Posted : September 17, 2007
Results First Posted : September 16, 2015
Last Update Posted : October 16, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Carotid Artery Disease||Device: PROTÉGÉ™ GPS™ and PROTÉGÉ™ RX Carotid Stent Systems and SpiderFX™ Embolic Protection Device||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1500 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Carotid Revascularization With ev3 Arterial Technology Evolution Post Approval Study|
|Study Start Date :||May 2007|
|Actual Primary Completion Date :||January 2014|
|Actual Study Completion Date :||January 2014|
Device: PROTÉGÉ™ GPS™ and PROTÉGÉ™ RX Carotid Stent Systems and SpiderFX™ Embolic Protection Device
Carotid artery stenting with distal embolic protection.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00530504
|United States, New York|
|Stony Brook University Hospital|
|Stony Brook, New York, United States|
|United States, Tennessee|
|Wellmont Medical Center|
|Kingsport, Tennessee, United States|
|Principal Investigator:||Gary Ansel, MD||MidWest Cardiology Research Foundation|
|Principal Investigator:||Robert Safian, MD||William Beaumont Hospitals|