Optimized C-arm Cone Beam CT for the Endovascular Treatment (EVT) of Acute Stroke

NCT ID: NCT04774510

Last Updated: 2024-01-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-15
• Study Completion Date: 2022-11-28

Brief Summary

When it comes to acute stroke, everyone deserves the best care. Today, more patients can benefit from endovascular treatment (EVT) in a comprehensive stroke center. With the significant advances in C-arm Cone Beam CT (CBCT) imagings directly in the neuro angio-suite (NAS), the investigators are now able to identify, plan and treat stroke patients in the NAS, without the need for a separate CT scan. This provides valuable, time-saving support for critical patients in acute need of EVT. The main objective is to assess the diagnostic confidence of this optimized C-arm Cone Beam CT, named in french ASO, in the NAS for the detection of brain abnormalities and hemorrhagic complications for critical patients with acute stroke. The secondary objectives are to study 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 dose for this ASO.

Detailed 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 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.

Conditions

Stroke, Acute

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Optimized C-ARM CBCT

An optimized C-arm CBCT evaluation with a different acquisition geometry and a novel software for the rapid, quality improved and less-artefacts assessment of brain parenchyma and angiogram.

Group Type: OTHER

Diagnostic Test: optimized C-Arm Cone Beam Computed Tomography

Intervention Type: OTHER

Optimized C-ARM CBCT using new geometry and a novel software can rapidly and accurately detected brain abnormalities and hemorrhagic complications for critical patients with acute stroke. This rapid assessment would eliminate the need for the patient to be imaged in another scanner and be subsequently transported again to another room; all anatomic and physiologic imaging would occur in the neuro angiography suite (NAS).

Interventions

Diagnostic Test: optimized C-Arm Cone Beam Computed Tomography

Optimized C-ARM CBCT using new geometry and a novel software can rapidly and accurately detected brain abnormalities and hemorrhagic complications for critical patients with acute stroke. This rapid assessment would eliminate the need for the patient to be imaged in another scanner and be subsequently transported again to another room; all anatomic and physiologic imaging would occur in the neuro angiography suite (NAS).

Intervention Type: OTHER

Other Intervention Names

C-ARM CBCT, XperCT Butterfly

Eligibility Criteria

Inclusion Criteria

aged ≥ 18 years diagnosed with an acute stroke and needed for a EVT affiliation to compulsory French social security scheme (beneficiary or right-holder) Consent from the patient if their level of consciousness is sufficient or from their relatives. If none is possible at the inclusion, consent will be obtained as soon as possible

Exclusion Criteria

Being under tutelage or legal guardianship ; Ongoing pregnancy, breastfeeding

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vanessa CHALUMEAU, MD

Role: PRINCIPAL_INVESTIGATOR

APHP

Locations

service de Neuroradiologie interventionnelle NEURI - Hôpital Bicêtre

Le Kremlin-Bicêtre, Kremlin-Bicêtre, France

Countries

France

Other Identifiers

APHP210221

Identifier Type: -

Identifier Source: org_study_id