SYNCHRONISE: LVO Triage Timing and Outcome Study

NCT ID: NCT04608617

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 600 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-03-09
• Study Completion Date: 2023-04-26

Brief Summary

The objective of this study is to evaluate the impact of Viz LVO in hospital systems with non-interventional and interventional (spoke and hub) stroke centers on the timing and outcomes of patients with suspected acute ischemic stroke indicated for mechanical thrombectomy.

Detailed Description

This is a multi-center, non-randomized observational study of acute ischemic stroke patients whose CTA scans are analyzed by Viz LVO to support clinicians in making stroke triage decisions,. The study results will be compared to a cohort from enrolling centers prior to Viz LVO implementation that will serve as a historical control. Data will be collected retrospectively from the time of presentation through 90 days post discharge.

The study will include patients undergoing imaging for a suspected LVO acute ischemic stroke. The post-Viz LVO intervention group will consist of patients who either presented to or underwent transfer to an interventional center, from a non-interventional center, following image analysis by Viz LVO. Data will be collected retrospectively on consecutive patients meeting eligibility criteria from the date of implementation up to 5 years post implementation.

The control group will consist of patients who either presented to or underwent transfer to an interventional center, from a non-interventional center, for evaluation prior to the implementation of Viz LVO. Data will be collected on consecutive patients from one day prior to implementation, back as far as 2 years prior to implementation

Conditions

Stroke, Ischemic

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

Pre-Viz

Pre-Viz LVO implementation patient data utilized as a control data set

Baseline Effectiveness Cohort

Intervention Type: OTHER

No Intervention was performed for the pre-Viz group. Record review to establish operational metrics only occurred.

Post-Viz

Patient data collected post-Viz LVO implementation

Viz LVO (De Novo Number DEN170073)

Intervention Type: DEVICE

Viz LVO is a notification-only, parallel workflow tool for use by hospital networks and trained clinicians to identify and communicate images of specific patients to a specialist, independent of standard of care workflow.

Viz LVO uses an artificial intelligence algorithm to analyze images for findings suggestive of a pre-specified clinical condition and to notify an appropriate medical specialist of these findings in parallel to standard of care image interpretation. Identification of suspected findings is not for diagnostic use beyond notification. Specifically, the device analyzes CT angiogram images of the brain acquired in the acute setting and sends notifications to a neurovascular specialist that a suspected large vessel occlusion has been identified and recommends review of those images. Images can be previewed through a mobile application.

Interventions

Viz LVO (De Novo Number DEN170073)

Viz LVO is a notification-only, parallel workflow tool for use by hospital networks and trained clinicians to identify and communicate images of specific patients to a specialist, independent of standard of care workflow.

Viz LVO uses an artificial intelligence algorithm to analyze images for findings suggestive of a pre-specified clinical condition and to notify an appropriate medical specialist of these findings in parallel to standard of care image interpretation. Identification of suspected findings is not for diagnostic use beyond notification. Specifically, the device analyzes CT angiogram images of the brain acquired in the acute setting and sends notifications to a neurovascular specialist that a suspected large vessel occlusion has been identified and recommends review of those images. Images can be previewed through a mobile application.

Intervention Type: DEVICE

Baseline Effectiveness Cohort

No Intervention was performed for the pre-Viz group. Record review to establish operational metrics only occurred.

Intervention Type: OTHER

Other Intervention Names

ContaCT

Eligibility Criteria

Inclusion Criteria

• Age of 18 years or greater
• Signs and symptoms consistent with the diagnosis of a large vessel occlusive stroke
• Pre-treatment National Institutes of Health Stroke Scale (NIHSS) ≥ 6
• Aspects Score ≥6
• Patient must have a suspected LVO in M1.
• Patient with an intention to treat with mechanical thrombectomy with confirmation of LVO by the CT/CTA radiographic report with the reading diagnosis.

Exclusion Criteria

• Unable to undergo a brain imaging (i.e. severe contrast medium allergy, claustrophobia)

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

Sponsors

Viz.ai, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dr. Thomas Devlin

Role: PRINCIPAL_INVESTIGATOR

CHI Memorial

Dr. Ameer Hassan

Role: PRINCIPAL_INVESTIGATOR

Valley Baptist

Locations

Wellstar Neurosurgery

Atlanta, Georgia, United States

Semmes-Murphey

Memphis, Tennessee, United States

Valley Baptist Medical Center

Harlingen, Texas, United States

Countries

United States

Other Identifiers

VIZ-LVO-03

Identifier Type: -

Identifier Source: org_study_id