Silent Brain Infarction After Endovascular Arch Procedures

NCT04489277 | Completed DMC

• 1 other identifier: INSERM UMR_S 999
• Study Type: observational
• Target: 91
• Locations: 2 countries
• Sites: 2

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.

Conditions

Aortic Arch Aneurysm

Keywords

Thoracic endovascular aortic repair; Silent cerebral infarction; Stroke; Magnetic resonance imaging; DW-MRI; Aortic arch disease

Outcome Measures

Primary Outcomes (1)

• frequency of silent cerebral infarcts on DW-MRI

  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.

  7 days

Secondary Outcomes (1)

• perioperative ischemic stroke

  30 days

Study Arms (2)

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

Device: Endovascular Arch Procedures

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

Device: Endovascular Arch Procedures

Interventions

Endovascular Arch Procedures DEVICE

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

Patients with Silent Brain Infarction; Patients without Silent Brain Infarction

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Consecutive patients, who received routine postoperative DW-MRI within 7 days after endovascular aortic arch repair between September 2018 and January 2020 at the University Hospital Hamburg-Eppendorf (Hamburg, Germany) and Marie Lannelongue Hospital (Paris, France) were identified.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (2)

Marie Lannelongue Hospital (Paris, France)

Paris, France

Location

University Hospital Hamburg-Eppendorf (Hamburg, Germany)

Hamburg, Germany

Location

Related Publications (1)

• Charbonneau P, Kolbel T, Rohlffs F, Eilenberg W, Planche O, Bechstein M, Ristl R, Greenhalgh R, Haulon S; STEP collaborators. Silent Brain Infarction After Endovascular Arch Procedures: Preliminary Results from the STEP Registry. Eur J Vasc Endovasc Surg. 2021 Feb;61(2):239-245. doi: 10.1016/j.ejvs.2020.11.021. Epub 2020 Dec 22.

  PMID: 33358103 DERIVED

MeSH Terms

Conditions

Aneurysm, Aortic Arch; Stroke

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 17 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Stephan Haulon, Proessor Tilo Kölbel

Study Record Dates

• First Submitted: July 23, 2020
• First Posted: July 28, 2020
• Study Start: September 1, 2018
• Primary Completion: January 31, 2020
• Study Completion: January 31, 2020
• Last Updated: August 6, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1); FR (1)