Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Stroke Acute
Type
Interventional
Phase
Not Applicable
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Diagnostic

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

Design: ASO-AVC is a french academic pilot study by exploring the diagnostic confidence of optimized C-arm Cone Beam CT (ASO) realized directly in the neuro angio-suite (NAS). To compare the effectiveness and safety of ASO diagnostic, the variability of the diagnostic accuracy concerning the staging...

Design: ASO-AVC is a french academic pilot study by exploring the diagnostic confidence of optimized C-arm Cone Beam CT (ASO) realized directly in the neuro angio-suite (NAS). To compare the effectiveness and safety of ASO diagnostic, the variability of the diagnostic accuracy concerning the staging of the stroke, the analysis of the brain vessel, the relevance of artefact reduction post treatment and the amount of delivered dose, the investigator proposed to assess clinical usefulness of ASO in the diagnostic process of stroke. Intervention: No modification of patient care will be required by this protocol. All patients participating in the study will undergo standard diagnostic, procedural and control imagings, which consist of : diagnostic imaging studies (MRI or CT scan), usual C-arm Cone Beam CT in the NAS during EVT to insure no procedural complication and control imaging studies (MRI or CT scan) at 24 hours ; decisions concerning further diagnostics will be made by the physician in charge. Apart from theses standard imagings, patients will undergo the ASO. The ASO imagings will be anonymized and recorded in a centralized database called PACS (Picture Archiving and Communication System), in order to a centralized radiological reading by the Imaging Core Lab. They will be reviewed by radiologist readers to rate diagnostic image quality through a questionnaire, and in a second time the data will be included in a comparative evaluation with the diagnostic and control imagings.

Tracking Information

NCT #
NCT04774510
Collaborators
Not Provided
Investigators
Principal Investigator: Vanessa CHALUMEAU, MD APHP