SYNCHRONISE: LVO Triage Timing and Outcome Study

Observational Study of Automated Detection for Identification, Triage, and Timely Intervention in Large Vessel Occlusions- SYNCHRONISE

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke, Ischemic
• Intervention / Treatment: Device: Viz LVO (De Novo Number DEN170073)

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

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Viz.ai Clinical Affairs; Phone Number: 6503044355; Email: evens@viz.ai

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30312
      • Recruiting
      • Wellstar Neurosurgery
      • Contact: Dr. Rishi Gupta, MD
  • Tennessee
    • Memphis, Tennessee, United States, 38120
      • Recruiting
      • Semmes-Murphey
      • Contact: Lucas Elijovich, MD; Email: lelijovich@semmes-murphey.com
      • Contact: Amanda Nolte, MS; Email: annolte@semmes-murphey.com
  • Texas
    • Harlingen, Texas, United States, 78550
      • Recruiting
      • Valley Baptist Medical Center
      • Contact: Dr. Ameer Hassan, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All consecutive patients, that meet eligibility criteria, undergoing imaging for a suspected LVO acute ischemic stroke indicated for mechanical thrombectomy

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pre-Viz; Pre-Viz LVO implementation patient data utilized as a control data set
Post-Viz; Patient data collected post-Viz LVO implementation	Device: 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.; Other Names: ContaCT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Transfer patients: Time from spoke CT/CTA to door-out	Time in minutes from CT/CTA imaging to time leaving the spoke center	up to 1 day (1440 minutes)
Non-transfer patients: Time from Hub door to groin puncture	Time in minutes from arrival a hub center to start time of treatment	up to 1 day (1440 minutes)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time from Spoke Door-In to Door-Out (DIDO)	Time in minutes from arrival at spoke hospital to departure to hub hospital	up to 1 day (1440 minutes)
Time from Spoke CT/CTA to Specialist Notification	Time in minutes from CT/CTA imaging to time an interventionalist was notified	up to 1 day (1440 minutes)
Time from Spoke CT/CTA to Groin Puncture	Time in minutes from CT/CTA imaging to start time of treatment	up to 1 day (1440 minutes)
Time from Spoke Door to Groin Puncture	Time in minutes from departure to hub hospital to start time of treatment	up to 1 day (1440 minutes)
Length of ICU Stay/Total Length of Stay	Number of days in hospital in the ICU and the total number of days in hospital	Hospital admit to discharge, up to 30 days
Modified Rankin Scale (mRS) at Discharge and 90 Days	The Modified Rankin Score (mRS) is a 6 point disability scale with possible scores ranging from 0 to 5. A separate category of 6 is usually added for patients who expire. A score of 0 is a patient with no residual symptoms. Scores increase with severity to 5 which equals severe disability.	90 days
National Institutes of Health Stroke Scale (NIHSS) at Discharge	The National Institutes of Health Stroke Scale (NIHSS) is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. A trained observer rates the patent's ability to answer questions and perform activities. Ratings for each item are scored on a 3- to 5-point scale, with 0 as normal, and there is an allowance for untestable items. Scores range from 0 to 42, with higher scores indicating greater severity.	On date of discharge, up to 30 days
Patient Disposition at Discharge and 90 Days	Data will be collected on whether or not the patient was discharged to their home or another type of care facility, and where they are located 90 days post hospital discharge	90 days

Collaborators and Investigators

• Sponsor: Viz.ai, Inc.
• Investigators: Principal Investigator: Dr. Thomas Devlin, CHI Memorial; Principal Investigator: Dr. Ameer Hassan, Valley Baptist

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2021
• Primary Completion (Anticipated): December 1, 2025
• Study Completion (Anticipated): January 1, 2026

Study Registration Dates

• First Submitted: October 11, 2020
• First Submitted That Met QC Criteria: October 23, 2020
• First Posted (Actual): October 29, 2020

Study Record Updates

• Last Update Posted (Actual): April 27, 2022
• Last Update Submitted That Met QC Criteria: April 26, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Artificial Intelligence; Large Vessel Occlusion
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: VIZ-LVO-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No