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

NCT05155956 | Active Not Recruiting DMC

• 1 other identifier: 850188
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (1)

• number of intra-operative cerebral microemboli

  TCD

  during RelayBranch procedure

Secondary Outcomes (3)

• Post-operative microemboli (seen on post-op day 1 study)

  post-op day 1

• Change in CBFv

  intra-op and post-op day 1

• Change in cerebral autoregulation

  intra-op and post-op day 1

Interventions

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: 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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead
• Bolton Medical: collaborator

Study Sites (2)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Aortic Aneurysm, Thoracic; Dissection, Thoracic Aorta

Interventions

Ultrasonography, Doppler, Transcranial

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Aortic Dissection; Dissection, Blood Vessel; Acute Aortic Syndrome

Intervention Hierarchy (Ancestors)

Echoencephalography; Neuroradiography; Neuroimaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiography; Ultrasonography; Ultrasonography, Doppler; Diagnostic Techniques, Neurological; Investigative Techniques

Study Officials

• Steven R Messe, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2021
• First Posted: December 14, 2021
• Study Start: December 15, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 15, 2025

Record last verified: 2025-06

Locations

US (2)