NCT04608617

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2021

Typical duration for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 11, 2020

Completed
18 days until next milestone

First Posted

Study publicly available on registry

October 29, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

March 9, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 22, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 26, 2023

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

2 years

First QC Date

October 11, 2020

Last Update Submit

September 6, 2024

Conditions

Stroke, Ischemic

Keywords

Artificial IntelligenceLarge Vessel Occlusion

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (8)

  • Time from Spoke Door-In to Door-Out (DIDO)

    up to 1 day (1440 minutes)

  • Time from Spoke CT/CTA to Specialist Notification

    up to 1 day (1440 minutes)

  • Time from Spoke CT/CTA to Groin Puncture

    up to 1 day (1440 minutes)

  • Time from Spoke Door to Groin Puncture

    up to 1 day (1440 minutes)

  • Length of ICU Stay/Total Length of Stay

    Hospital admit to discharge, up to 30 days

  • +3 more secondary outcomes

Study Arms (2)

Pre-Viz

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

Other: Baseline Effectiveness Cohort

Post-Viz

Patient data collected post-Viz LVO implementation

Device: Viz LVO (De Novo Number DEN170073)

Interventions

Viz LVO (De Novo Number DEN170073)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.

Also known as: ContaCT
Post-Viz
Baseline Effectiveness CohortOTHER

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

Pre-Viz

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Wellstar Neurosurgery

Atlanta, Georgia, 30312, United States

Location

Semmes-Murphey

Memphis, Tennessee, 38120, United States

Location

Valley Baptist Medical Center

Harlingen, Texas, 78550, United States

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Dr. Thomas Devlin

    CHI Memorial

    PRINCIPAL INVESTIGATOR

  • Dr. Ameer Hassan

    Valley Baptist

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2020

First Posted

October 29, 2020

Study Start

March 9, 2021

Primary Completion

February 22, 2023

Study Completion

April 26, 2023

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

US(3)