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About
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
Full 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.
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Inclusion criteria
Category I - Anatomical high risk factors
Category II - Co-morbid risk factors
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Interventional model
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120 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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