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Completed

NCT Number: NCT04489277

Silent Brain Infarction After Endovascular Arch Procedures

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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Key information

Conditions

Aortic Arch Aneurysm Aneurysm Aneurysm, Aortic Arch Aortic Aneurysm Aortic Aneurysm, Thoracic Aortic Diseases Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Marie Lannelongue Hospital (Paris, France), Paris, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endovascular Arch Procedures

Device

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. perioperative ischemic stroke

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Collaborators

  • Baylor College of Medicine
  • Emory University Hospital, Atlanta, GA
  • Fondation Hôpital Saint-Joseph
  • I.R.C.C.S. Policlinico San Donato, San Donato Milanese, Italy
  • Jung Stilling Hospital
  • Loyola University Medical Center, Maywood, IL
  • Maastricht University Medical Centre, Maastricht, Netherlands
  • Massachusetts General Hospital
  • Mayo Clinic, Rochester, MN
  • Memorial Care Long Beach Heart & Vascular Institute, Long Beach, CA
  • Sanger Heart and Vascular Institute, Charlotte, NC
  • Sentara Vascular/Eastern Virginia Medical School, Norfolk, VA
  • Stanford University
  • UAB School of Medicine, Birmingham, AL
  • University Hospital Heidelberg
  • University Hospital of Freiburg, Freiburg, Germany
  • University Hospital of Mainz, Mainz, Germany
  • Universitätsklinikum Hamburg-Eppendorf
  • Vascular Surgical Research Group, Imperial College, London, UK

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jul 28, 2020
Registry last updated
Aug 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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