Automated Detection and Triage of Large Vessel Occlusions Using Artificial Intelligence for Early and Rapid Treatment (ALERT)

NCT04142879 | Unknown

• 1 other identifier: ALERT-VIZ-LVO-02
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

Post Market, Prospective, Randomized, Controlled, multi center data collection study to evaluate the use of Viz versus the standard of care in stroke workflow and clinical outcome parameters.

Conditions

Stroke Workflow and Clinical Outcome Parameters

Keywords

Large Vessel Occlusion

Outcome Measures

Primary Outcomes (2)

• Non-Interventional Centers

  Non-Interventional Centers: Evaluate the Door-In to Door-Out (DIDO) time for subjects in which Viz was utilized versus standard of care.

  Time of subject presentation through up to 90 days post treatment.

• Interventional Centers

  Interventional Centers: Evaluate the Door-In to Groin Puncture time for subjects in which Viz was utilized versus standard of care.

  Time of subject presentation through up to 90 days post treatment.

Secondary Outcomes (1)

• Workflow Endpoints

  Time of subject presentation through up to 90 days post treatment.

Study Arms (2)

Non-Interventional Centers

Cohort A: Viz Subjects Initially Presenting to a Non-Interventional Center The group will be comprised of subjects randomized to Viz and who initially present to a non- interventional center. Cohort B: Subjects Initially Presenting to a Non-Interventional Center The standard of care group will be comprised of subjects randomized to not have Viz notification and who initially present to a non-interventional center.

Device: Viz Device Software

Interventional Centers

Cohort C: Viz Subjects Initially Presenting to an Interventional Center The group will be comprised of subjects randomized to Viz and who initially present to a interventional center. Cohort D: Subjects Initially Presenting to a Interventional Center The standard of group will be comprised of subjects randomized to not have Viz notification and who initially present to an interventional center.

Device: Viz Device Software

Interventions

Viz Device Software DEVICE

Viz uses artificial intelligence to automatically detect, triage and notify stroke specialists of suspected large vessel occlusion (LVOs) and computed tomography angiogram (CTA) imaging. Viz includes functionality to automatically process computed tomography perfusion (CTP) images. Additionally, Viz includes a mobile non-diagnostic image viewer and HIPAA-compliant secure messaging.

Also known as: Viz

Interventional Centers; Non-Interventional Centers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects with an identified LVO per Viz will be eligible for the study.

You may qualify if:

• Age of 18 years or greater.
• Signs and symptoms consistent with the diagnosis of a stroke.
• Stroke protocol imaging (CTA) with a confirmed presence of anterior LVO via Viz.

You may not qualify if:

• Poor or incomplete CTA imaging data.
• Disagreement between neuroradiologist and stroke specialist or neurointerventionalist relative to presence of a stroke.
• Other serious, advanced, or terminal illness (investigator judgment) requiring treatment that significantly delays initiating transfer and/or treatment for stroke.

Sponsors & Collaborators

• Providence Little Company of Mary-Torrance: lead
• Viz.ai, Inc.: collaborator

Study Sites (1)

Providence Little Company of Mary Medical Center-Torrance

Torrance, California, 90501, United States

Location

Related Publications (4)

• Benjamin EJ, Virani SS, Callaway CW, Chamberlain AM, Chang AR, Cheng S, Chiuve SE, Cushman M, Delling FN, Deo R, de Ferranti SD, Ferguson JF, Fornage M, Gillespie C, Isasi CR, Jimenez MC, Jordan LC, Judd SE, Lackland D, Lichtman JH, Lisabeth L, Liu S, Longenecker CT, Lutsey PL, Mackey JS, Matchar DB, Matsushita K, Mussolino ME, Nasir K, O'Flaherty M, Palaniappan LP, Pandey A, Pandey DK, Reeves MJ, Ritchey MD, Rodriguez CJ, Roth GA, Rosamond WD, Sampson UKA, Satou GM, Shah SH, Spartano NL, Tirschwell DL, Tsao CW, Voeks JH, Willey JZ, Wilkins JT, Wu JH, Alger HM, Wong SS, Muntner P; American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2018 Update: A Report From the American Heart Association. Circulation. 2018 Mar 20;137(12):e67-e492. doi: 10.1161/CIR.0000000000000558. Epub 2018 Jan 31. No abstract available.

  PMID: 29386200 BACKGROUND

• Goyal M, Menon BK, van Zwam WH, Dippel DW, Mitchell PJ, Demchuk AM, Davalos A, Majoie CB, van der Lugt A, de Miquel MA, Donnan GA, Roos YB, Bonafe A, Jahan R, Diener HC, van den Berg LA, Levy EI, Berkhemer OA, Pereira VM, Rempel J, Millan M, Davis SM, Roy D, Thornton J, Roman LS, Ribo M, Beumer D, Stouch B, Brown S, Campbell BC, van Oostenbrugge RJ, Saver JL, Hill MD, Jovin TG; HERMES collaborators. Endovascular thrombectomy after large-vessel ischaemic stroke: a meta-analysis of individual patient data from five randomised trials. Lancet. 2016 Apr 23;387(10029):1723-31. doi: 10.1016/S0140-6736(16)00163-X. Epub 2016 Feb 18.

  PMID: 26898852 BACKGROUND

• Khatri P, Yeatts SD, Mazighi M, Broderick JP, Liebeskind DS, Demchuk AM, Amarenco P, Carrozzella J, Spilker J, Foster LD, Goyal M, Hill MD, Palesch YY, Jauch EC, Haley EC, Vagal A, Tomsick TA; IMS III Trialists. Time to angiographic reperfusion and clinical outcome after acute ischaemic stroke: an analysis of data from the Interventional Management of Stroke (IMS III) phase 3 trial. Lancet Neurol. 2014 Jun;13(6):567-74. doi: 10.1016/S1474-4422(14)70066-3. Epub 2014 Apr 27.

  PMID: 24784550 BACKGROUND

• Goyal M, Jadhav AP, Bonafe A, Diener H, Mendes Pereira V, Levy E, Baxter B, Jovin T, Jahan R, Menon BK, Saver JL; SWIFT PRIME investigators. Analysis of Workflow and Time to Treatment and the Effects on Outcome in Endovascular Treatment of Acute Ischemic Stroke: Results from the SWIFT PRIME Randomized Controlled Trial. Radiology. 2016 Jun;279(3):888-97. doi: 10.1148/radiol.2016160204. Epub 2016 Apr 19.

  PMID: 27092472 BACKGROUND

Study Officials

• Jason Tarpley, M.D., Ph. D.

  Providence Little Company of Mary Medical Center-Torrance

  PRINCIPAL INVESTIGATOR

• Heliane Kauffman, B.S.N., R.N.

  Providence Health & Services

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Diana Gallegos, LVN

CONTACT

310-303-5515; diana.gallegos@providence.org

Treasure Joyce, LVN

CONTACT

310-303-5448; treasure.joyce@providence.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neurointerventionist

Study Record Dates

• First Submitted: October 25, 2019
• First Posted: October 29, 2019
• Study Start: December 1, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2021
• Last Updated: October 29, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)