Silent Brain Infarction After Endovascular Arch Procedures

Completed

• Conditions: Aortic Arch Aneurysm
• Interventions: Device: Endovascular Arch Procedures

• Registration Number: NCT04489277
• Lead Sponsor: Medical University of Vienna

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.

Study Timeline

• Study Start: 2018-09-01
• Primary Completion: 2020-01-31
• Study Completion: 2020-01-31
• Study First Submitted: 2020-07-23
• Study First Submitted QC: 2020-07-23
• Study First Posted: 2020-07-28
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-04
• Last Update Posted: 2020-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 91

Inclusion Criteria

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with Silent Brain Infarction	Endovascular Arch Procedures	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
Patients without Silent Brain Infarction	Endovascular Arch Procedures	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

Primary Outcome Measures

Name	Time	Method
frequency of silent cerebral infarcts on DW-MRI	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.

Secondary Outcome Measures

Name	Time	Method
perioperative ischemic stroke	30 days	Secondary 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.

Trial Locations

Locations (2)

University Hospital Hamburg-Eppendorf (Hamburg, Germany); 🇩🇪 Hamburg, Germany

Marie Lannelongue Hospital (Paris, France); 🇫🇷 Paris, France