Thoracic Aortic AneurysmCHaMPNCT05155956
Cerebral Hemodynamics and Microemboli During Placement of Relay®Branch Thoracic Stent-Graft System
An observational study of Thoracic Aortic Aneurysm and Thoracic Aortic Dissection, run by University of Pennsylvania at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracic Aortic Aneurysm, Thoracic Aortic Dissection, Microemboli
- What is being tested?
- transcranial Doppler ultrasonography (TCD)
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Dec 2021to Dec 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104
About this study
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.
Read the 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.
- Being tested
- transcranial Doppler ultrasonography (TCD)
- Medical subject headings
- Aortic Aneurysm, Thoracic, Dissection, Thoracic Aorta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
number of intra-operative cerebral microemboli
TCD
Measured: during RelayBranch procedure
Secondary outcomes (3)
Post-operative microemboli (seen on post-op day 1 study)
TCD
Measured: post-op day 1
Change in CBFv
TCD
Measured: intra-op and post-op day 1
Change in cerebral autoregulation
TCD
Measured: intra-op and post-op day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2021
- Study start15 Dec 2021
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic Aortic AneurysmStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Bolton Medical
- Responsible party
- Sponsor
- Investigators
- Steven R Messe, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05155956
- Sponsor's protocol ID
- 850188
- Acronym
- CHaMP
- Status last verified
- Jul 2026
- First submitted
- 30 Nov 2021
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided