SYNCHRONISE: LVO Triage Timing and Outcome Study

Recruiting

• Conditions: Stroke, Ischemic
• Interventions: Other: Baseline Effectiveness Cohort; Device: Viz LVO (De Novo Number DEN170073)

• Registration Number: NCT04608617
• Lead Sponsor: Viz.ai, Inc.

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

Study Timeline

• Study First Submitted: 2020-10-11
• Study First Submitted QC: 2020-10-23
• Study First Posted: 2020-10-29
• Study Start: 2021-03-09
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-26
• Last Update Posted: 2022-04-27
• Primary Completion: 2025-12
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pre-Viz	Baseline Effectiveness Cohort	Pre-Viz LVO implementation patient data utilized as a control data set
Post-Viz	Viz LVO (De Novo Number DEN170073)	Patient data collected post-Viz LVO implementation

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Time from Spoke Door to Groin Puncture	up to 1 day (1440 minutes)	Time in minutes from departure to hub hospital to start time of treatment
Length of ICU Stay/Total Length of Stay	Hospital admit to discharge, up to 30 days	Number of days in hospital in the ICU and the total number of days in hospital
Modified Rankin Scale (mRS) at Discharge and 90 Days	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.
Time from Spoke Door-In to Door-Out (DIDO)	up to 1 day (1440 minutes)	Time in minutes from arrival at spoke hospital to departure to hub hospital
Time from Spoke CT/CTA to Groin Puncture	up to 1 day (1440 minutes)	Time in minutes from CT/CTA imaging to start time of treatment
Time from Spoke CT/CTA to Specialist Notification	up to 1 day (1440 minutes)	Time in minutes from CT/CTA imaging to time an interventionalist was notified
National Institutes of Health Stroke Scale (NIHSS) at Discharge	On date of discharge, up to 30 days	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.
Patient Disposition at Discharge and 90 Days	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

Trial Locations

Locations (3)

Wellstar Neurosurgery; 🇺🇸 Atlanta, Georgia, United States

Semmes-Murphey; 🇺🇸 Memphis, Tennessee, United States

Valley Baptist Medical Center; 🇺🇸 Harlingen, Texas, United States