Comparing endovascular treatment and medical management for stroke patients with disabilities
Treatment With Endovascular Intervention for STroke Patients With Existing Disability
This study is testing whether a procedure called endovascular thrombectomy can help stroke patients with existing disabilities feel better compared to just using medication.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1060 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Cincinnati Academic / other |
| Locations | 25 sites (Phoenix, Arizona and 24 other locations) |
| Trial ID | NCT05911568 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with moderate-to-severe pre-stroke functional disabilities who have experienced an acute ischemic stroke.
Not a fit: Patients with terminal illnesses or those whose pre-stroke disabilities are deemed temporary may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide critical insights into effective treatment options for stroke patients with pre-existing disabilities.
How similar studies have performed: While endovascular thrombectomy has shown success in non-disabled stroke patients, this study addresses a novel population that has not been extensively studied in previous trials.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Phoenix, Arizona and 24 other locations
- HonorHealth — Phoenix, Arizona, United States (Recruiting)
- Kaiser Permanente Los Angeles Medical Center — Los Angeles, California, United States (Recruiting)
- University of California at Los Angeles — Los Angeles, California, United States (Recruiting)
- Standford — Palo Alto, California, United States (Recruiting)
- University of Cincinnati San Diego — San Diego, California, United States (Recruiting)
- Swedish Medical Center — Englewood, Colorado, United States (Recruiting)
- Hartford Health Hospital — Hartford, Connecticut, United States (Recruiting)
- Yale University — New Haven, Connecticut, United States (Recruiting)
- University of Miami — Miami, Florida, United States (Recruiting)
- Emory University — Atlanta, Georgia, United States (Recruiting)
- University of Chicago — Chicago, Illinois, United States (Recruiting)
- University of Louisville — Louisville, Kentucky, United States (Recruiting)
- Boston Medical Center — Boston, Massachusetts, United States (Recruiting)
- Barnes Jewish Hospital — Saint Loius, Missouri, United States (Recruiting)
- New York University — Brooklyn, New York, United States (Recruiting)
- Icahn School of Medicine at Mount Sinai — New York, New York, United States (Recruiting)
- Columbia University — New York, New York, United States (Recruiting)
- University of Cincinnati Medical Center — Cincinnati, Ohio, United States (Recruiting)
- Providence St. Vincent Medical Center — Portland, Oregon, United States (Recruiting)
- University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States (Recruiting)
- Baptist Memorial Hospital — Memphis, Tennessee, United States (Recruiting)
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (Recruiting)
- University of Texas at Austin — Austin, Texas, United States (Recruiting)
- University of Washington — Seattle, Washington, United States (Recruiting)
- West Virginia University — Morgantown, West Virginia, 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.