Comparing endovascular treatment and medical management for stroke patients with disabilities

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to compare the risks and benefits of endovascular thrombectomy (EVT) versus medical management in patients who have experienced an acute ischemic stroke and have pre-existing moderate-to-severe disabilities. It will enroll individuals with large vessel occlusion (LVO) who present within 24 hours of their last known well time and have a modified Rankin score (mRS) of 3 or 4 prior to their stroke. The study will take place at 12 comprehensive stroke centers, focusing on the effectiveness and safety of these two treatment approaches in a diverse patient population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Adult patients (≥18 years)
2. Moderate-to-severe pre-stroke functional disability, defined as mRS 3-4, for at least 3 months prior to stroke onset
3. Presenting to study hospital within 24 hours of last known well time
4. Diagnosis of acute ischemic stroke
5. Intracranial causative occlusion of the internal carotid artery or the M1 or dominant M2 segments of the middle cerebral artery visualized on the baseline CT(or MR) angiogram
6. Presenting CT Alberta Stroke Program Early CT (ASPECT) score ≥3 or MRI ASPECT score ≥4
7. Presenting NIH Stroke Scale score ≥6
8. Informed consent from patient if competent or from legally authorized representative

Exclusion Criteria:

1. Known diagnosis of a terminal cancer or terminal illness at the time of stroke
2. Assessment of pre-stroke functional status cannot be performed during the hospital stay
3. Pre-stroke disability deemed temporary in the investigator's opinion (for example, recovering from a general medical illness or traumatic bodily injury)

Where it's running

• University of Alabama at Birmingham
  Birmingham, Alabama, United States Recruiting
• HonorHealth
  Phoenix, Arizona, United States Recruiting
• Kaiser Permanente Los Angeles Medical Center
  Los Angeles, California, United States Recruiting
• Cedars-Sinai Medical Center
  Los Angeles, California, United States Recruiting
• University of California at Los Angeles
  Los Angeles, California, United States Recruiting
• Stanford University
  Palo Alto, California, United States Recruiting

Study contacts

• Principal investigator: Eva Mistry, MD — University of Cincinnati
• Study coordinator: Eva Mistry, MD
• Email: mistryea@ucmail.uc.edu
• Phone: 513-558-1291

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.