Silent Brain Infarction After Endovascular Arch Procedures

Aortic Arch Aneurysm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04489277
• Other study ID #: INSERM UMR_S 999
• Status: Completed
• Start date: September 1, 2018
• Est. completion date: January 31, 2020

Study information

• Verified date: August 2020
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: January 31, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Aortic Arch Aneurysm
• Brain Infarction
• Infarction

Intervention

Device:
• Endovascular Arch Procedures
Endovascular Arch Procedures (TEVAR, Branch endografts, Fenestrated endografts)

Locations

Country	Name	City	State
France	Marie Lannelongue Hospital (Paris, France)	Paris
Germany	University Hospital Hamburg-Eppendorf (Hamburg, Germany)	Hamburg

Sponsors (20)

Lead Sponsor

Collaborator

Medical University of Vienna

Baylor Research Hospital, Dallas, TX, Diakonie Hospital Jung-Stilling, Siegen, Germany, Emory University Hospital, Atlanta, GA, Groupe Hospitalier Paris Saint Joseph, Heidelberg University Hospital, Heidelberg, Germany, I.R.C.C.S. Policlinico San Donato, San Donato Milanese, Italy, 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 School of Medicine, Stanford, CA, UAB School of Medicine, Birmingham, AL, Universitätsklinikum Hamburg-Eppendorf, University Hospital of Freiburg, Freiburg, Germany, University Hospital of Mainz, Mainz, Germany, Vascular Surgical Research Group, Imperial College, London, UK

Countries where clinical trial is conducted

France,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	perioperative ischemic stroke	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.	30 days