NCT04489277

Silent Brain Infarction After Endovascular Arch Procedures

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 91 (actual)
• Sponsor: Medical University of Vienna · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Aortic Arch Aneurysm

Interventions

Type	Name	Description
DEVICE	Endovascular Arch Procedures	Endovascular Arch Procedures (TEVAR, Branch endografts, Fenestrated endografts)

Timeline

• Start date: 2018-09-01
• Primary completion: 2020-01-31
• Completion: 2020-01-31
• First posted: 2020-07-28
• Last updated: 2020-08-06

Locations

2 sites across 2 countries: France, Germany