The purpose of this study is to compare the safety and performance of WIRION™ EPD in patients undergoing carotid artery stenting to a performance goal based on an analysis of the results of previous US IDE carotid stenting with embolic protection studies
Patient registry procedures include:
- Clinical Events Committee (CEC); responsibility for validating all reported primary safety outcomes
- Data Safety Monitoring Board (DSMB); to review and evaluate safety data including serious adverse events
- 100% data monitoring; to compare data entered into the registry
- Source data verification; to assess the accuracy, completeness of registry data by comparing the data to external data sources (e.g., medical records, paper or electronic case report forms).
- Standard Operating Procedures; to address registry operations and analysis activities, such as patient recruitment, data collection, data management, data analysis and reporting for adverse events.
- Sample size assessment to specify the number of participants and follow up duration.
- Data Management Plan; to address situations where variables are reported as missing, unavailable, "non-reported," uninterpretable, or considered missing because of data inconsistency or out-of-range results
- Statistical analysis plan; describing the analytical principles and statistical techniques to be employed in order to address the primary and secondary objectives, as specified in the study protocol or plan.
- Carotid Artery Stent Procedure
Intervention Desc: Assessment of the study device (WIRION) during carotid artery stenting procedure in comparison to a performance of FDA approved filter type embolic protection devices ARM 1: Kind: Experimental Label: Arm 1 Description: Device: WIRION™ Embolic Protection System Interventions: Carotid Artery Stent
- Masking: Open Label
- Purpose: Prevention
- Endpoint: Safety Study
- Intervention: Single Group Assignment
|Type||Measure||Time Frame||Safety Issue|
|Primary||The rate of peri-procedural (within 30 days of procedure) death, stroke, and myocardial infarction.||Within 30 Days of procedure||Yes|
|Secondary||The rate of Device Success||Participants will be followed for the duration of the procedure, an expected average of 35 minutes||Yes|
|Secondary||The rate of Clinical Success||Participants will be followed for the duration of the procedure, an expected average of 35 minutes||Yes|
|Secondary||The rate of Access site complications||Within 30 Days of procedure||Yes|
|Secondary||Neurological events occurring within 30 days post procedure,including strokes and transient ischemic attacks||Within 30 Days of procedure||Yes|
|Secondary||Angiographic Success||Participants will be followed for the duration of the procedure, an expected average of 35 minutes||Yes|
|Secondary||Procedural Success||Participants will be followed for the duration of the procedure, an expected average of 35 minutes||Yes|
- Gardia Medical Lead