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Cerebral Hemodynamics and Microemboli During Placement of Relay®Branch Thoracic Stent-Graft System — CHaMP  

Thoracic Aortic Aneurysm Clinical Trial

Official title:
Cerebral Hemodynamics and Microemboli During Placement of Relay®Branch Thoracic Stent-Graft System

Clinical Trial Summary

This is an observational cohort study addressing the incidence of cerebral microemboli and alterations of cerebral hemodynamic physiology of the Relay®Branch thoracic stent-graft system.

Clinical Trial Description

This study is a prospective multi-center observational study. Eligible patients will be enrolled in RelayBranch (NCT03214601). Participating centers must have capabilities of performing intra-operative TCD monitoring and post-operative TCD monitoring. If sites have performed TCD microembolic monitoring during previous RelayBranch procedures, we will also incorporate these data in our analysis. The primary objective is to assess the number and timing of cerebral microemboli during Relay®Branch thoracic stent-graft deployment, to identify the highest risk portions of the procedure. Secondary objectives include: correlate procedural microembolic burden with neuroimaging and clinical outcome; quantify post-operative microemboli, correlating with neuroimaging and clinical outcome; and quantify the changes in cerebral blood flow and cerebral autoregulation that happens during critical procedural epochs, correlating with neuroimaging and clinical outcome. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05155956
Study type Observational
Source University of Pennsylvania
Contact
Status Enrolling by invitation
Phase
Start date December 15, 2021
Completion date December 2025
View Details
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