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

NCT04774510 | Completed

• 1 other identifier: APHP210221
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke, Acute

Keywords

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Outcome Measures

Primary Outcomes (1)

• diagnostic confidence

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

  baseline

Secondary Outcomes (2)

• Assess the degree of inter-observer agreement

  baseline

• Evaluate diagnostic agreement with conventional diagnostic imaging: MRI and CT scan

  through study completion, an average of 48 hours

Study Arms (1)

Optimized C-ARM CBCT

OTHER

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.

Other: Diagnostic Test: optimized C-Arm Cone Beam Computed Tomography

Interventions

Diagnostic Test: optimized C-Arm Cone Beam Computed Tomography 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).

Also known as: C-ARM CBCT, XperCT Butterfly

Optimized C-ARM CBCT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Being under tutelage or legal guardianship ; Ongoing pregnancy, breastfeeding

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

service de Neuroradiologie interventionnelle NEURI - Hôpital Bicêtre

Le Kremlin-Bicêtre, Kremlin-Bicêtre, 94270, France

Location

MeSH Terms

Conditions

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

• Vanessa CHALUMEAU, MD

  APHP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2021
• First Posted: March 1, 2021
• Study Start: January 15, 2022
• Primary Completion: November 28, 2022
• Study Completion: November 28, 2022
• Last Updated: January 24, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)