Carotid Revascularization With ev3 Arterial Technology Evolution Post Approval Study (CREATE PAS)
|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.
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|