NCT01783639

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Gardia Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

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

• Carotid Artery Diseases
• Stroke

Interventions

Type	Name	Description
PROCEDURE	Carotid Artery Stent	Assessment of the study device (WIRION) during carotid artery stenting procedure in comparison to a performance of FDA approved filter type embolic protection devices

Timeline

• Start date: 2013-02-01
• Primary completion: 2013-12-01
• Completion: 2015-04-01
• First posted: 2013-02-05
• Last updated: 2017-08-07
• Results posted: 2015-07-22

Locations

10 sites across 3 countries: Belgium, Germany, Italy