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Clinical Trial Summary

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


Clinical Trial 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. ;


Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


NCT number NCT01783639
Study type Interventional
Source Gardia Medical
Contact
Status Completed
Phase N/A
Start date February 2013
Completion date April 2015

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