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

Thoracic Aortic Aneurysm Clinical Trial

— CHaMP  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05155956
• Other study ID #: 850188
• Status: Enrolling by invitation
• Start date: December 15, 2021
• Est. completion date: December 2025

Study information

• Verified date: October 2023
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 20
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Enrollment in NCT03214601 based on presence of a thoracic aortic aneurysm, penetrating atherosclerotic ulcer, or chronic type B dissection that would require coverage of the brachiocephalic trunk and/or left carotid if a non-branching endograft were implanted Advanced heart failure with plan to treat with LVAD
• At least 18 years of age
• Patients enrolled prospectively must sign the informed consent form
• If patients underwent TCD monitoring during a previous RelayBranch procedure as part of routine clinical care, we will also incorporate their data in our analysis

Exclusion Criteria:

• Skull defect or skull surgery that will preclude monitoring
• Known lack of TCD temporal acoustic window (if had TCD in past)
• Expected surgical position will preclude access to the patient's head for monitoring

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Thoracic
• Aortic Dissection
• Microemboli
• Thoracic Aortic Aneurysm
• Thoracic Aortic Dissection

Intervention

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: Brief in duration (<300msec) High intensity (amplitude >3 dB above background) Unidirectional Audible chirp or snap Further, CBFv monitoring during may inform flow perturbations that occur during cardiac or vascular manipulations.

Locations

Country	Name	City	State
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Penn Presbyterian Medical Center	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	Bolton Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of intra-operative cerebral microemboli	TCD	during RelayBranch procedure
Secondary	Post-operative microemboli (seen on post-op day 1 study)	TCD	post-op day 1
Secondary	Change in CBFv	TCD	intra-op and post-op day 1
Secondary	Change in cerebral autoregulation	TCD	intra-op and post-op day 1