Posterior cerebraL ArTery Occlusion Study (PLATO)

June 3, 2024 updated by: Boston Medical Center

Endovascular Therapy vs Medical Management of PosterIor Cerebral Artery Occlusion Stroke

For this retrospective study, the investigators will collect and analyze data of patients who presented with posterior artery occlusion and underwent mechanical thrombectomy (the type of endovascular stroke treatment) and intravenous thrombolysis (the type of non-endovascular stroke treatment).

The electronic health records will be queried for the demographic, medical history, and outcomes data of all patients with posterior cerebral artery occlusion who underwent mechanical thrombectomy, intravenous thrombolysis (IVT), or medical management.

Study Overview

Status

Completed

Conditions

Detailed Description

The primary aims of the research are to evaluate, in patients presenting with posterior artery occlusion (PCA), whether favorable outcome would be superior for EVT compared to Medically Management (MM), inclusive of intravenous thrombolysis (IVT), as measured by:

  • 90-day modified Rankin Scale (mRS) ordinal shift or
  • decrease in NIH Stroke Scale/Score (NIHSS) by two points at 24 hours or at hospital discharge

The secondary aims are to evaluate in patients presenting with PCA occlusion, other outcome and safety metrics:

  • 90-day functional independence, mRS 0-2
  • 90-day excellent outcome, mRS 0-1
  • Visual field recovery (none, partial, complete) by 90-days
  • rate of reperfusion by modified thrombolysis in cerebral infarction (TICI) scale grade
  • any intracranial hemorrhage
  • symptomatic intracranial hemorrhage
  • mortality

In subgroup analysis, the investigators aim to identify subgroups that may confer differential treatment benefit by:

  • location of occlusion on the PCA segment (P1, P2, P3)
  • NIHSS strata (0-6, 7-15,>16)
  • time from symptom onset to treatment (0 to <6h vs 6-24h)
  • posterior circulation (PC) Acute Stroke Prognosis Early Computed Tomography Score (ASPECTS)
  • visual field defect on presentation

The investigators hypothesize that greater benefit in outcomes would be seen in EVT treated patients with higher NIHSS, more proximal PCA occlusion, higher PC ASPECTS scores, and shorter time from symptom onset to treatment.

Study Type

Observational

Enrollment (Actual)

1282

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Helsinki, Finland, 00290
        • Helsinki university hospital
  • Germany
      • Berlin, Germany
        • Charite Berlin
      • Bochum, Germany
        • Universitätsklinikum Knappschaftskrankenhaus Bochum
      • Dresden, Germany
        • University Clinics Dresden
      • Erlangen, Germany
        • Universitätsklinikum Erlangen
      • Hamburg, Germany
        • University Medical Center Hamburg-Eppendorf
      • Heidelberg, Germany, 69117
        • Heidelberg University
  • Italy
      • Bologna, Italy, 47521
        • IRCCS Istituto delle Scienze Neurologiche di Bologna
  • Portugal
      • Lisboa, Portugal, 1349-019
        • Egas Moniz Hospital
      • Lisbon, Portugal
        • Centro Hospitalar Universitário de Lisboa Central
  • Spain
      • Barcelona, Spain
        • Vall d'Hebron
  • Switzerland
      • Basel, Switzerland
        • University Hospital Basel
    • Vaud
      • Lausanne, Vaud, Switzerland, 1011
        • Lausanne University Hospital
  • United States
    • Florida
      • Miami, Florida, United States, 33124
        • University of Miami
      • Miami, Florida, United States, 33176
        • Miami Baptist Health
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University School of Medicine
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston Medical Center
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Cooper University Healthcare
    • New York
      • Buffalo, New York, United States, 14261
        • University of Buffalo
      • New York, New York, United States, 10003
        • Mount Sinai Health
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15261
        • University of Pittsburgh Medical Center
    • Texas
      • Houston, Texas, United States, 77030
        • UT Texas Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients identified from electronic health records who have undergone stroke medical management treatment from 1/01/2003 to 01/01/2022 and patients who have undergone EVT stroke treatment from 01/01/2015 - 01/01/2022.

Description

Inclusion Criteria:

  • Had an ischemic stroke with isolated posterior cerebral artery occlusion (P1, P2, or P3 segments) and was medically managed or managed with EVT during the study time period.

Exclusion Criteria:

  • Patient with documented basilar artery occlusion and concomitant PCA occlusion
  • Patient with documented basilar artery occlusion, migration with secondary PCA occlusion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Medical management cohort
Patients who have undergone medical management stroke treatment from 1/01/2003 to 01/01/2022; this could include intravenous thrombolysis.
EVT management cohort
Patients who have undergone EVT stroke treatment from 01/01/2015 to 01/01/2022

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in stroke outcome based on modified Rankin Scale (mRS)
Time Frame: baseline, 90 days
The Modified Rankin Scale (mRS) assesses disability in patients who have suffered a stroke and is compared over time to check for recovery and degree of continued disability. Scores can range from 0-6, where 0 is no disability, 5 is disability requiring constant care for all needs, and 6 is death. For this outcome an ordinal shift analysis will be done, assessing all changes across the range from baseline at 90 days.
baseline, 90 days
Change in NIH Stroke Score (NIHSS)
Time Frame: baseline, 7 days
The NIH Stroke Scale/Score (NIHSS) is 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. Scores can range from 0 to 42 and higher scores are associated with more severe stroke: 1-4= Minor stroke, 5-15= Moderate stroke, 15-20= Moderate/severe stroke, and 21-42 =Severe stroke.
baseline, 7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Medical Center

Collaborators

Heidelberg University

Investigators

  • Principal Investigator: Thanh N Nguyen, MD, Boston Medical Center, Neurology
  • Principal Investigator: Simon Nagel, MD, Heidelberg University Hospital, Neurology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 5, 2022

Primary Completion (Actual)

May 31, 2022

Study Completion (Actual)

January 31, 2023

Study Registration Dates

First Submitted

March 4, 2022

First Submitted That Met QC Criteria

March 13, 2022

First Posted (Actual)

March 22, 2022

Study Record Updates

Last Update Posted (Estimated)

June 4, 2024

Last Update Submitted That Met QC Criteria

June 3, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-40712

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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