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NCT Number: NCT05155956

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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:

  • 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.

Primary outcomes

  1. number of intra-operative cerebral microemboli

    Time frame: during RelayBranch procedure

    TCD

Secondary outcomes

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

    Time frame: post-op day 1

    TCD

  2. Change in CBFv

    Time frame: intra-op and post-op day 1

    TCD

  3. Change in cerebral autoregulation

    Time frame: intra-op and post-op day 1

    TCD

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • Bolton Medical

Registry information

Acronym: CHaMP

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Dec 14, 2021
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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