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Silent Brain Infarction After Endovascular Arch Procedures

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Medical University of Vienna

Status

Completed

Conditions

Aortic Arch Aneurysm

Treatments

Device: Endovascular Arch Procedures

Study type

Observational

Funder types

Other

Identifiers

NCT04489277
INSERM UMR_S 999

Details and patient eligibility

About

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.

Full 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.

Enrollment

91 patients

Sex

All

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

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

Trial design

91 participants in 2 patient groups

Patients with Silent Brain Infarction
Description:
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 with silent brain infarction
Treatment:
Device: Endovascular Arch Procedures
Patients without Silent Brain Infarction
Description:
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 without silent brain infarction
Treatment:
Device: Endovascular Arch Procedures

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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