CT (Computerized Tomography) for Late EndovasculAr Reperfusion (CLEAR)

July 21, 2023 updated by: Boston Medical Center

Non-Contrast CT vs CTP or MRI Selection vs Medical Management in Late Presentation of Large Vessel Occlusion Stroke, 6-24 Hours. A Multicenter Retrospective Study

The objective of this multicenter, retrospective, cross-sectional, chart review study is to compare outcomes (disability, complications and mortality) of patients with large vessel occlusion stroke presenting at late time window selected by either Non-Contrast CT (NCCT) only, advanced imaging with CTP (Computed Tomography Perfusion), MRI (Magnetic Resonance Imaging), or medical management.

Boston Medical Center (BMC) will serve as the main data coordinating site. Fifteen additional sites will seek local IRB approval or ethics approval. The aggregated de-identified data will be analyzed comparing types of interventions and outcomes by type of imaging or medical management.

Study Overview

Status

Completed

Conditions

Detailed Description

Additional subgroup analysis that are planned include:

  1. Futile Reperfusion in the Extended Window.

    We will evaluate clinical, imaging and time metric factors associated with successful reperfusion yet poor outcomes (modified Rankin 3-6) in the 6-24 hour window.

    An evaluation of factors associated with symptomatic intracranial hemorrhage and mortality will be conducted.

  2. Pre-Stroke disability.

    1. EVT patients treated in the extended window compared to Medical Management
    2. EVT patients treated in the extended window with pre-existing disability vs. those without pre-existing disability

  3. Intravenous Thrombolysis in the Extended Window

    We aim to compare the safety and outcomes of bridging IVT in patients with acute ischemic stroke due to large vessel occlusion (LVO) who underwent EVT 6 to 24 hours after time-last-known-well.

  4. Medical Management vs CT selected Patients

    We hypothesize that in patients with large vessel occlusion in the anterior circulation presenting in the 6 to 24 hour window, patients who are selected by non-contrast CT and treated with endovascular therapy have more favorable outcomes (ordinal mRS shift) as compared to patients who are medically managed.

  5. Sex differences in the Extended Window

    In this study we aim to asses whether there are sex differences in clinical outcomes and safety of EVT in patients presenting in the 6-24 hour time window.

  6. Transfer Analysis

It is not well established whether transfer patients presenting in the extended window should have repeat imaging upon receipt at the endovascular center after an interim time window.

We hypothesize that within a 0 to 2, or 2 to 4 hour delay between images of the primary stroke center to receiving endovascular center, transferred patients in the extended window, who undergo thrombectomy with successful reperfusion will have similar outcomes in patients with or without repeat imaging at the receiving center.

We aim to compare the safety and outcomes of late-window bridging IVT vs. direct EVT for LVO acute ischemic stroke in the 6-24 hour time window.

Study Type

Observational

Enrollment (Actual)

2790

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

  • Belgium
      • Leuven, Belgium
        • UZ Leuven
  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H2X 0C1
        • Centre Hospitalier de l'Universite de Montreal
  • Finland
      • Helsinki, Finland
        • Helsinki University Hospital
  • France
      • Lille, France
        • Universite de Lille
  • Germany
      • Dresden, Germany
        • University Hospital Carl Gustav Carus
      • Heidelberg, Germany
        • Heidelberg University
  • Japan
      • Osaka, Japan
        • National Cerebral and Cardiovascular Center
      • Osaka, Japan
        • National Hospital Organization Osaka National Hospital
  • Portugal
      • Lisbon, Portugal
        • Hospital de Egas Moniz
  • Spain
      • Barcelona, Spain
        • Val D'Hebron
  • Switzerland
      • Bern, Switzerland
        • Bern University Hospital
      • Lausanne, Switzerland
        • Lausanne University Hospital
  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30303
        • Grady Health; Marcus Stroke & Neuroscience Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston Medical Center
      • Worcester, Massachusetts, United States, 01655
        • University of Massachusetts
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Cooper University Health Care
    • New York
      • Syracuse, New York, United States, 13202
        • Upstate University Hospital
    • Ohio
      • Toledo, Ohio, United States, 43606
        • University of Toledo
      • Toledo, Ohio, United States, 43608
        • Mercy Health Neuroscience Institute

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Retrospective chart abstraction will be done on consecutive patients treated with a large vessel occlusion stroke who meet the inclusion and none of the exclusion criteria between January 1, 2014 and May 1, 2022.

Description

Inclusion Criteria:

  • Patients presenting 6-24 hours from last known well with large vessel occlusion stroke
  • ASPECTS score 5 or greater from last known well
  • January 1, 2014 to May 1, 2022

Exclusion Criteria:

-Time last seen well to treatment <6 hours from last known well

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in patients' disability based on a Modified Rankin Scale
Time Frame: baseline, 90 days
The Modified Rankin Score (mRS) is a 6 point disability scale with possible scores ranging from 0 to 5. Lower scores correlate with less disability/dependence.
baseline, 90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intracranial hemorrhage incidence
Time Frame: 90 days
Number of cases of intracranial hemorrhage divided by appropriate denominator.
90 days
Mortality rate
Time Frame: 90 days
Number of deaths divided by appropriate denominator.
90 days

Collaborators and Investigators

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

Sponsor

Boston Medical Center

Collaborators

Medtronic
Society of Vascular and Interventional Neurology

Investigators

  • Principal Investigator: Thanh Nguyen, MD, Boston Medical Center

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

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)

February 15, 2020

Primary Completion (Actual)

May 23, 2021

Study Completion (Actual)

May 1, 2022

Study Registration Dates

First Submitted

September 17, 2019

First Submitted That Met QC Criteria

September 18, 2019

First Posted (Actual)

September 19, 2019

Study Record Updates

Last Update Posted (Estimated)

July 24, 2023

Last Update Submitted That Met QC Criteria

July 21, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-37843

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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