Safety and Performance Evaluation of WIRION™ EPD in Patients Undergoing Carotid Artery Stenting "WISE"

Completed

Phase N/A Results

Trial Description

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

Detailed Description

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.

Conditions

Interventions

  • 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

Trial Design

  • Masking: Open Label
  • Purpose: Prevention
  • Endpoint: Safety Study
  • Intervention: Single Group Assignment

Outcomes

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

Sponsors