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

Last updated: June 13, 2025
Sponsor: University of Pennsylvania
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Occlusions

Heart Disease

Aneurysm

Treatment

transcranial Doppler ultrasonography (TCD)

Clinical Study ID

NCT05155956
850188
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Enrollment in NCT03214601 based on presence of a thoracic aortic aneurysm,penetrating atherosclerotic ulcer, or chronic type B dissection that would requirecoverage of the brachiocephalic trunk and/or left carotid if a non-branchingendograft 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 partof routine clinical care, we will also incorporate their data in our analysis

Exclusion

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

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: transcranial Doppler ultrasonography (TCD)
Phase:
Study Start date:
December 15, 2021
Estimated Completion Date:
December 31, 2026

Study 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.

Connect with a study center

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Penn Presbyterian Medical Center

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

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