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

Stroke Clinical Trial

Official title: The WISE Study is a Pivotal Study Evaluating the Safety and Performance of WIRION™ EPD in Patients Undergoing Carotid Artery Stenting

Status Completed

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

• Carotid Artery Diseases
• Stroke

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