Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
ID07001852

Endovascular Therapy for Late Window Ischemic Stroke Patients Selected by Automatic Plain Computed Tomography

Led by Santiago Ortega Gutierrez · Updated on 2025-10-16

500

Participants Needed

2

Research Sites

N/A

Total Duration

On this page

Sponsors

S

Santiago Ortega Gutierrez

Lead Sponsor

F

Fundació Ictus

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating endovascular therapy (EVT) for adults aged 18 to 80 who have suffered an acute ischemic stroke caused by a large blockage in the brain's anterior circulation. This phase III global clinical trial tests whether EVT, which removes blood clots from brain arteries, can benefit stroke patients when used up to 72 hours after symptoms start. The study focuses on using a widely available non-contrast CT brain scan analyzed by automated software, instead of advanced imaging, to select patients who may still benefit from treatment. Participants will be randomly assigned to one of two groups: one receiving standard medical care plus EVT, and the other receiving standard medical care alone. EVT involves inserting a catheter through a blood vessel to remove the clot using approved thrombectomy devices, performed by specialized stroke or neurointerventional experts. Treatment is guided by the automated CT software and must begin within 6 to 72 hours of stroke onset. Both groups will be followed with exams and imaging up to 90 days. During the study, participants will undergo brain imaging, neurological assessments, and evaluations of stroke recovery. Researchers will measure global disability at 90 days using the modified Rankin Scale, along with secondary outcomes like stroke severity changes, brain injury size, reperfusion success, quality of life, and survival. Safety monitoring includes checking for brain bleeding and other adverse events. Functional outcomes are assessed by independent reviewers unaware of treatment assignments to ensure unbiased results.

CONDITIONS

Brief Title

EnDOvascular Therapy for Late WiNdow IschEmic Stroke Patients Selected bY AutoMatic Plain ComputErized Tomography

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 80 years
  • Pre-stroke Modified Rankin Scale (mRS) score of 0-1 for ages 18 to 70; mRS score of 0 for those older than 70
  • Signs and symptoms of acute ischemic stroke within 24 to 72 hours from last known well
  • Baseline NIH Stroke Scale score of 8 or greater
  • Non-contrast CT imaging showing anterior circulation large vessel occlusion by automated software or CT angiography
  • Core brain tissue damage volume 70 cc or less determined by automated deep learning software or ASPECTS score 6 or higher
  • Arterial puncture procedure within 72 hours after stroke onset
  • Arterial puncture within 90 minutes of initial CT scan
  • Ability to randomize within 72 hours after stroke symptom onset
  • Signed informed consent from participant or legally authorized representative
Not Eligible

You will not qualify if you...

  • Pregnant females or females of child-bearing potential with positive pregnancy test
  • Severe allergy to contrast media not controlled by medications
  • High blood pressure not controlled despite medication (systolic >185 mmHg or diastolic >110 mmHg)
  • CT evidence of midline brain shift, herniation, intracranial hemorrhage, or mass effect
  • Bilateral strokes
  • Clot retrieval attempted less than 6 hours before
  • Treatment with thrombolytics more than 4.5 hours after last known well
  • Presence of intracranial tumors
  • Life expectancy less than 90 days before stroke onset
  • Participation in another conflicting randomized clinical trial
  • Suspected septic embolus or bacterial endocarditis
  • Pre-existing neurological or psychiatric disease affecting evaluations (e.g., dementia with certain medications)
  • Any condition that prevents endovascular procedure or poses significant risk as judged by investigator

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) for imaging and eligibility assessment

Treatment

Duration - Up to 72 hours from stroke onset

Participants receive either endovascular therapy plus standard medical management or standard medical management alone for acute ischemic stroke. Endovascular therapy involves a mechanical thrombectomy procedure performed within 6 to 72 hours after stroke onset.

1 procedure visit plus hospitalization for treatment and monitoring

Follow-up

Duration - Approximately 3 months (90 days ±14 days)

Participants are monitored for recovery, functional outcomes, and safety up to 90 days after treatment.

Multiple follow-up visits including assessments at 24 hours, 5 days or discharge, and 90 days

Trial Site Locations

Total: 2 locations

1

University of Iowa

Iowa City, Iowa, United States, 52242

Not Yet Recruiting

2

Erebouni Medical Center

Yerevan, Armenia

Actively Recruiting

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Research Team

S

Santiago Ortega, MD

J

Jorge Cespedes, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Thrombectomy for anterior circulation stroke beyond 6 h from time last known well (AURORA): a systematic review and individual patient data meta-analysis.

Tudor G Jovin, Raul G Nogueira, Maarten G Lansberg...

https://pubmed.ncbi.nlm.nih.gov/34774198