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| Name | Class |
|---|---|
| Bolton Medical | INDUSTRY |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transcranial Doppler ultrasonography (TCD) | Other | 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:
Further, CBFv monitoring during may inform flow perturbations that occur during cardiac or vascular manipulations. |
| Measure | Description | Time Frame |
|---|---|---|
| number of intra-operative cerebral microemboli | TCD | during RelayBranch procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative microemboli (seen on post-op day 1 study) | TCD | post-op day 1 |
| Change in CBFv | TCD | intra-op and post-op day 1 |
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Inclusion Criteria:
Exclusion Criteria:
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20 subjects will be enrolled at multiple participating centers. All eligible subjects will be identified based on enrollment in RelayBranch (NCT03214601) or in their hum. We anticipate enrollment will be complete within 2 years.
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| Name | Affiliation | Role |
|---|---|---|
| Steven R Messe, MD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States | ||
| Penn Presbyterian Medical Center |
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| Change in cerebral autoregulation | TCD | intra-op and post-op day 1 |
| Philadelphia |
| Pennsylvania |
| 19104 |
| United States |
| ID | Term |
|---|---|
| D017545 | Aortic Aneurysm, Thoracic |
| D000094629 | Dissection, Thoracic Aorta |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001018 | Aortic Diseases |
| D000784 | Aortic Dissection |
| D000094665 | Dissection, Blood Vessel |
| D000094683 | Acute Aortic Syndrome |
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| ID | Term |
|---|---|
| D017585 | Ultrasonography, Doppler, Transcranial |
| ID | Term |
|---|---|
| D004453 | Echoencephalography |
| D009485 | Neuroradiography |
| D059906 | Neuroimaging |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011859 | Radiography |
| D014463 | Ultrasonography |
| D018608 | Ultrasonography, Doppler |
| D003943 | Diagnostic Techniques, Neurological |
| D008919 | Investigative Techniques |
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