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

Primary Purpose

Stroke, Acute

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Diagnostic Test: optimized C-Arm Cone Beam Computed Tomography
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Stroke, Acute focused on measuring Cerebrovascular Disorders, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Vascular Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • service de Neuroradiologie interventionnelle NEURI - Hôpital Bicêtre

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Optimized C-ARM CBCT

Arm Description

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.

Outcomes

Primary Outcome Measures

diagnostic confidence
To assess the diagnostic confidence of ASO diagnostic with a centralized radiological reading

Secondary Outcome Measures

Assess the degree of inter-observer agreement
measuring assessor agreement in term of image quality and interpretation of ASO
Evaluate diagnostic agreement with conventional diagnostic imaging: MRI and CT scan
Comparative evaluation with the diagnostic and control imagings.

Full Information

First Posted
February 15, 2021
Last Updated
February 26, 2021
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT04774510
Brief Title
Optimized C-arm Cone Beam CT for the Endovascular Treatment (EVT) of Acute Stroke
Acronym
ASO-AVC
Official Title
Optimized C-arm Cone Beam CT (CBCT) in the Neuro Angio-suite (NAS) for the Endovascular Treatment (EVT) of Acute Ischemic and Hemorrhagic Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2021 (Anticipated)
Primary Completion Date
April 3, 2022 (Anticipated)
Study Completion Date
April 3, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Acute
Keywords
Cerebrovascular Disorders, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Vascular Diseases

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Optimized C-ARM CBCT
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Diagnostic Test: optimized C-Arm Cone Beam Computed Tomography
Other Intervention Name(s)
C-ARM CBCT, XperCT Butterfly
Intervention Description
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).
Primary Outcome Measure Information:
Title
diagnostic confidence
Description
To assess the diagnostic confidence of ASO diagnostic with a centralized radiological reading
Time Frame
baseline
Secondary Outcome Measure Information:
Title
Assess the degree of inter-observer agreement
Description
measuring assessor agreement in term of image quality and interpretation of ASO
Time Frame
baseline
Title
Evaluate diagnostic agreement with conventional diagnostic imaging: MRI and CT scan
Description
Comparative evaluation with the diagnostic and control imagings.
Time Frame
through study completion, an average of 48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vanessa CHALUMEAU, MD
Phone
33145217389
Email
vanessa.chalumeau@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vanessa CHALUMEAU, MD
Organizational Affiliation
APHP
Official's Role
Principal Investigator
Facility Information:
Facility Name
service de Neuroradiologie interventionnelle NEURI - Hôpital Bicêtre
City
Le Kremlin Bicêtre
State/Province
Kremlin-Bicêtre
ZIP/Postal Code
94270
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurent SPELLE
Phone
01 45 21 73 80
Email
laurent.spelle@aphp.fr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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