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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Thoracic Aortic Aneurysm; Thoracic Aortic Dissection; Microemboli
• Intervention / Treatment: Other: transcranial Doppler ultrasonography (TCD)

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Penn Presbyterian Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of intra-operative cerebral microemboli	TCD	during RelayBranch procedure

Secondary Outcome Measures

Outcome Measure	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
Change in cerebral autoregulation	TCD	intra-op and post-op day 1

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: Bolton Medical
• Investigators: Principal Investigator: Steven R Messe, MD, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2021
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: November 30, 2021
• First Submitted That Met QC Criteria: November 30, 2021
• First Posted (Actual): December 14, 2021

Study Record Updates

• Last Update Posted (Actual): October 24, 2023
• Last Update Submitted That Met QC Criteria: October 23, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Dissection, Blood Vessel; Acute Aortic Syndrome; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Thoracic; Aortic Dissection; Dissection, Thoracic Aorta
• Other Study ID Numbers: 850188

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No