Clinical trial NCT04489277: Silent Brain Infarction After Endovascular Arch Procedures
Official title: Silent Brain Infarction After Endovascular Arch Procedures: Preliminary Results From the STEP Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Arch Aneurysm
Keywords: Thoracic endovascular aortic repair
Silent cerebral infarction
Stroke
Magnetic resonance imaging
DW-MRI
Aortic arch disease
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
Collaborators: name: Fondation Hôpital Saint-Joseph
name: Universitätsklinikum Hamburg-Eppendorf
name: Vascular Surgical Research Group, Imperial College, London, UK
name: Sanger Heart and Vascular Institute, Charlotte, NC
name: Loyola University Medical Center, Maywood, IL
name: UAB School of Medicine, Birmingham, AL
name: Heidelberg University Hospital, Heidelberg, Germany
name: University Hospital of Freiburg, Freiburg, Germany
name: Stanford University
name: Massachusetts General Hospital
name: Baylor Research Hospital, Dallas, TX
name: Emory University Hospital, Atlanta, GA
name: University Hospital of Mainz, Mainz, Germany
name: Diakonie Hospital Jung-Stilling, Siegen, Germany
name: Mayo Clinic, Rochester, MN
name: Sentara Vascular/Eastern Virginia Medical School, Norfolk, VA
name: Maastricht University Medical Centre, Maastricht, Netherlands
name: I.R.C.C.S. Policlinico San Donato, San Donato Milanese, Italy
name: Memorial Care Long Beach Heart & Vascular Institute, Long Beach, CA
First posted: 2020-07-28
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

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.

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

Primary outcomes:
measure: frequency of silent cerebral infarcts on DW-MRI
timeFrame: 7 days
Secondary outcomes:
measure: perioperative ischemic stroke
timeFrame: 30 days
Other outcomes:
Locations:
city: Paris
country: France
facility: Marie Lannelongue Hospital (Paris, France)
city: Hamburg
country: Germany
facility: University Hospital Hamburg-Eppendorf (Hamburg, Germany)
Study officials:
References:
citation: 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.