SYNCHRONISE: LVO Triage Timing and Outcome Study

Stroke, Ischemic Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 ;

Related Conditions & MeSH terms

• Ischemic Stroke
• Stroke, Ischemic

• NCT number: NCT04608617
• Study type: Observational
• Source: Viz.ai, Inc.
• Contact: Viz.ai Clinical Affairs
• Phone: 6503044355
• Email: evens@viz.ai
• Status: Recruiting
• Start date: March 9, 2021
• Completion date: January 2026