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Silent Brain Infarction After Endovascular Arch Procedures

Silent Brain Infarction After Endovascular Arch Procedures: Preliminary Results From the STEP Registry

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04489277
Enrollment
91
Registered
2020-07-28
Start date
2018-09-01
Completion date
2020-01-31
Last updated
2020-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Arch Aneurysm

Keywords

Thoracic endovascular aortic repair, Silent cerebral infarction, Stroke, Magnetic resonance imaging, DW-MRI, Aortic arch disease

Brief summary

This is the largest study to evaluate incidence and distribution of silent cerebral infarction (SBI) following endovascular repair for disease of the aortic arch. Also, it is the first cohort to include total endovascular arch repair and devices flushed with carbon dioxide (CO2) to prevent gaseous cerebral embolization.

Detailed description

Introduction. Poor data exist concerning the rate of silent cerebral ischemic events following endovascular treatment of the aortic arch. The objective of this work was to quantify these lesions using the STEP registry. Methods. This multicentre retrospective cohort study included consecutive patients treated with an aortic endoprosthesis deployed in Ishimaru zone 0 to 3 and brain diffusion-weighted magnetic resonance imaging (DW-MRI) within 7 days after the procedure. DW-MRI was performed to identify the location and number of new silent brain infarctions (SBI), microbleeds ans general outcome of the patients.

Interventions

DEVICEEndovascular Arch Procedures

Endovascular Arch Procedures (TEVAR, Branch endografts, Fenestrated endografts)

Sponsors

Fondation Hôpital Saint-Joseph
CollaboratorOTHER
Universitätsklinikum Hamburg-Eppendorf
CollaboratorOTHER
Vascular Surgical Research Group, Imperial College, London, UK
CollaboratorUNKNOWN
Sanger Heart and Vascular Institute, Charlotte, NC
CollaboratorUNKNOWN
Loyola University Medical Center, Maywood, IL
CollaboratorUNKNOWN
UAB School of Medicine, Birmingham, AL
CollaboratorUNKNOWN
Heidelberg University Hospital, Heidelberg, Germany
CollaboratorUNKNOWN
University Hospital of Freiburg, Freiburg, Germany
CollaboratorUNKNOWN
Stanford University
CollaboratorOTHER
Massachusetts General Hospital
CollaboratorOTHER
Baylor Research Hospital, Dallas, TX
CollaboratorUNKNOWN
Emory University Hospital, Atlanta, GA
CollaboratorUNKNOWN
University Hospital of Mainz, Mainz, Germany
CollaboratorUNKNOWN
Diakonie Hospital Jung-Stilling, Siegen, Germany
CollaboratorUNKNOWN
Mayo Clinic, Rochester, MN
CollaboratorUNKNOWN
Sentara Vascular/Eastern Virginia Medical School, Norfolk, VA
CollaboratorUNKNOWN
Maastricht University Medical Centre, Maastricht, Netherlands
CollaboratorUNKNOWN
I.R.C.C.S. Policlinico San Donato, San Donato Milanese, Italy
CollaboratorUNKNOWN
Memorial Care Long Beach Heart & Vascular Institute, Long Beach, CA
CollaboratorUNKNOWN
Medical University of Vienna
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

* Included patients underwent a proximal endograft deployment in Ishimaru zone 0 to 3

Exclusion criteria

* Missing preoperative computed tomography angiography (CTA) scan of the chest and any circumstances that precluded the DW-MRI to be performed in the appropriate time window, such as a medical condition or an MRI contraindication

Design outcomes

Primary

MeasureTime frameDescription
frequency of silent cerebral infarcts on DW-MRI7 daysPrimary outcomes were the frequency of silent cerebral infarcts on DW-MRI after endovascular arch procedures, and to identify the number, the distribution, and predictors of these lesions.

Secondary

MeasureTime frameDescription
perioperative ischemic stroke30 daysSecondary outcomes were perioperative ischemic stroke defined as a brain infarction of ischemic etiology which occurs during surgery or within 30 days after surgery, TIA, hemorrhagic stroke, 30-day mortality, spinal cord ischemia, length of stay and discharge disposition.

Countries

France, Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026