Skip to main content
OpenTrials
Completed

NCT Number: NCT04096248

CT (Computerized Tomography) for Late EndovasculAr Reperfusion

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Stroke, Cardiovascular Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UZ Leuven, Leuven, Belgium

Loading trial locations.

About this study

Additional subgroup analysis that are planned include:

  • 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.

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

  • 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.

  • 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.

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Intracranial hemorrhage incidence

    Time frame: 90 days

    Number of cases of intracranial hemorrhage divided by appropriate denominator.

  2. Mortality rate

    Time frame: 90 days

    Number of deaths divided by appropriate denominator.

Sponsors and collaborators

Lead sponsor

Boston Medical Center

Other

Collaborators

  • Medtronic
  • Society of Vascular and Interventional Neurology

Registry information

Official study title

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

Acronym: CLEAR

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Sep 19, 2019
Registry last updated
Jun 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.