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

Medical University of Vienna2 sites in 2 countries91 target enrollmentSeptember 1, 2018

ConditionsAortic Arch Aneurysm

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Aortic Arch Aneurysm
Sponsor: Medical University of Vienna
Enrollment: 91
Locations: 2
Primary Endpoint: frequency of silent cerebral infarcts on DW-MRI
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 1, 2018

End Date

January 31, 2020

Last Updated

5 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Medical University of Vienna

Responsible Party

Principal Investigator

Wolf Eilenberg

Professor Stephan Haulon, Proessor Tilo Kölbel

Fondation Hôpital Saint-Joseph

Eligibility Criteria

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

Outcomes

Primary Outcomes

frequency of silent cerebral infarcts on DW-MRI

Time Frame: 7 days

Primary 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.