Carotid Revascularization With ev3 Arterial Technology Evolution Post Approval Study
- Conditions
- Carotid Artery Disease
- Registration Number
- NCT00530504
- Lead Sponsor
- Medtronic Endovascular
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1500
- 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
- Subjects with contraindications as outlined in the Instructions for Use
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Composite Rate of Death, Ipsilateral CVA, Procedure-related CVA, or Myocardial Infarction (MI) at 30 Days Post-procedure. 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Stony Brook University Hospital
🇺🇸Stony Brook, New York, United States
Wellmont Medical Center
🇺🇸Kingsport, Tennessee, United States
Stony Brook University Hospital🇺🇸Stony Brook, New York, United States