Carotid Revascularization With ev3 Arterial Technology Evolution Post Approval Study
This trial is active, not recruiting.
|Condition||carotid artery disease|
|Treatment||protÉgÉ® gps™ and protÉgÉ® rx carotid stent systems and spiderfx™ embolic protection device|
|Start date||May 2007|
|End date||January 2015|
|Trial size||3500 participants|
|Trial identifier||NCT00530504, P-2611|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
Composite rate of death, ipsilateral CVA, procedure-related CVA, or myocardial infarction (MI) at 30 days post-procedure.
time frame: 30 Days
Male or female participants of any age.
Inclusion Criteria: - 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 Exclusion Criteria: - Subjects with contraindications as outlined in the Instructions for Use
|Official title||Carotid Revascularization With ev3 Arterial Technology Evolution Post Approval Study|
|Principal investigator||Gary Ansel, MD|
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