Silent Brain Infarction After Endovascular Arch Procedures

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

91 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-09-01

Study Completion Date

2020-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Aortic Arch Aneurysm

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Patients with Silent Brain Infarction

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

Endovascular Arch Procedures

Intervention Type DEVICE

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

Patients without Silent Brain Infarction

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

Endovascular Arch Procedures

Intervention Type DEVICE

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

Interventions

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Endovascular Arch Procedures

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No