Thoracic Aortic Aneurysm Clinical Trial
— CHaMPOfficial title:
Cerebral Hemodynamics and Microemboli During Placement of Relay®Branch Thoracic Stent-Graft System
Verified date | October 2023 |
Source | University of Pennsylvania |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Enrolling by invitation |
Enrollment | 20 |
Est. completion date | December 2025 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania |
United States | Penn Presbyterian Medical Center | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pennsylvania | Bolton Medical |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | number of intra-operative cerebral microemboli | TCD | during RelayBranch procedure | |
Secondary | Post-operative microemboli (seen on post-op day 1 study) | TCD | post-op day 1 | |
Secondary | Change in CBFv | TCD | intra-op and post-op day 1 | |
Secondary | Change in cerebral autoregulation | TCD | intra-op and post-op day 1 |
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