Clinical Trials Logo

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05155956
Other study ID # 850188
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date December 15, 2021
Est. completion date December 2025

Study information

Verified date October 2023
Source University of Pennsylvania
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

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

Study Design


Intervention

Other:
transcranial Doppler ultrasonography (TCD)
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.

Locations

Country Name City State
United States Hospital of the University of Pennsylvania Philadelphia Pennsylvania
United States Penn Presbyterian Medical Center Philadelphia Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
University of Pennsylvania Bolton Medical

Country where clinical trial is conducted

United States, 

Outcome

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
See also
  Status Clinical Trial Phase
Recruiting NCT01390181 - The Effect of Losartan in Bicuspid Aortic Valve Patients N/A
Recruiting NCT00339053 - Immunonutrition and Thoracoabdominal Aorta Aneurysm Repair Phase 4
Not yet recruiting NCT05395598 - Incidence of Major Complication in Case of Thoracic Aortic Aneurysm
Recruiting NCT00549315 - Clinical Study of Thoracic Aortic Aneurysm Exclusion N/A
Recruiting NCT05777460 - Mid- and Long-term Outcomes of Custom-made Aortic Devices
Active, not recruiting NCT05146375 - Genes Modulating the Severity of Aortic Aneurysms (MSF1-TGFBR2)
Completed NCT01082172 - South American Thoracic Stent-Graft Study N/A
Recruiting NCT03824626 - Biomechanical Reappraisal of Planning for Thoracic Endovascular Aortic Repair
Completed NCT04663074 - Intravascular Ultrasound (IVUS) in Complex Aortic Endovascular Interventions
Recruiting NCT04747626 - B-SAFER: Branched Stented Anastomosis Frozen Elephant Trunk Repair N/A
Active, not recruiting NCT05143138 - Real-World Data Collection of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis When Used as a Bridging Stent With Branched and Fenestrated Endografts in the Treatment of Aortic Aneurysms Involving the Renal-Mesenteric Arteries
Completed NCT00111176 - STARZ-TX2 Clinical Study: Study of Thoracic Aortic Aneurysm Repair With the Zenith TX2 Endovascular Graft N/A
Recruiting NCT05639400 - Thoraflex Hybrid and Relay Extension Post-Approval Study
Terminated NCT02735720 - The CardiOvascular Remodeling Following Endovascular Aortic Repair (CORE) Study
Completed NCT02256163 - Identification of Genes and Pathogenesis Involved in Familial Thoracic Aortic Aneurysm N/A
Recruiting NCT06377033 - Using the EHR to Advance Genomic Medicine Across a Diverse Health System N/A
Recruiting NCT06094127 - Zenith Thoracic Alpha (ZTA) Post-Market Data Collection
Recruiting NCT03998631 - Comparison of Carbon Dioxide and Saline Flush to Saline Flush in TEVAR and TAVI Procedures to Reduce Cerebral Ischemia Phase 1
Completed NCT05414318 - CTAG Dissection/Trauma Post Marketing Surveillance Japan
Completed NCT04756778 - Indexed Aortic Area in Bicuspid Aortic Valve Aortopathy