Cerebral Hemodynamics and Microemboli During Placement of Relay®Branch Thoracic Stent-Graft System
NCT05155956 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 20
Last updated 2025-06-15
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.
Conditions
- Thoracic Aortic Aneurysm
- Thoracic Aortic Dissection
- Microemboli
Interventions
- OTHER
-
transcranial Doppler ultrasonography (TCD)
Transcranial Doppler (TCD) is a non-invasive ultrasound-based technique that facilitates insonation of the cerebral arteries. TCD probe design enables continuous monitoring of cerebral blood flow velocity (CBFv). TCD has a variety of clinical applications, including intraoperative monitoring for detection of microemboli. The TCD probe can be comfortably secured to the patient's head by a headframe in order to maintain continuous vessel insonation. Microembolic signals (MES) can be reliably detected based on standard criteria: 1. Brief in duration (\<300msec) 2. High intensity (amplitude \>3 dB above background) 3. Unidirectional 4. Audible chirp or snap Further, CBFv monitoring during may inform flow perturbations that occur during cardiac or vascular manipulations.
Sponsors & Collaborators
-
Bolton Medical
collaborator INDUSTRY - lead OTHER
Principal Investigators
-
Steven R Messe, MD · University of Pennsylvania
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-12-15
- Primary Completion
- 2026-12-31
- Completion
- 2026-12-31
Countries
- United States
Study Locations
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