NCT05911568 Treatment With Endovascular Intervention for STroke Patients With Existing Disability
| NCT ID | NCT05911568 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Cincinnati |
| Condition | Stroke |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,060 participants |
| Start Date | 2023-11-16 |
| Primary Completion | 2028-01-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,060 participants in total. It began in 2023-11-16 with a primary completion date of 2028-01-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
TESTED will compare the risks and benefits of endovascular thrombectomy (EVT) to medical management (no EVT) in ischemic stroke patients who have a blockage in one of the large blood vessels in the brain and have a moderate-to-severe disability prior to their stroke.
Eligibility 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)
Contact & Investigator
Eva Mistry, MD
PRINCIPAL INVESTIGATOR
University of Cincinnati
Frequently Asked Questions
Who can join the NCT05911568 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05911568 currently recruiting?
Yes, NCT05911568 is actively recruiting participants. Contact the research team at mistryea@ucmail.uc.edu for enrollment information.
Where is the NCT05911568 trial being conducted?
This trial is being conducted at Phoenix, United States, Los Angeles, United States, Los Angeles, United States, Palo Alto, United States and 11 additional locations.
Who is sponsoring the NCT05911568 clinical trial?
NCT05911568 is sponsored by University of Cincinnati. The principal investigator is Eva Mistry, MD at University of Cincinnati. The trial plans to enroll 1,060 participants.
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