In the study, researchers used neuroimaging to determine which patients would likely benefit from the procedure. According to Dr. Sila, they would examine how much brain tissue had suffered irreversible damage and how much might be able to be saved. If the amount of damaged tissue were no bigger than the size of a small apricot, researchers believed the patient could benefit from the therapy.
Neuro-interventionists would then use a mechanical stent retriever called the Trevo Retriever to remove the blood clot, followed by treatment with the clot-busting medication.
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The study had been stopped earlier this year after an FDA-approved planned interim review by the independent Data Safety Monitoring Board (DSMB) of data from the first 200 patients enrolled nationally because there was such a dramatic difference between the two arms of the study. The study had been designed to enroll up to a maximum of 500 patients.
Dr. Sila said that in Northeast Ohio, we have about 18,000 strokes per year. Stroke survivors commonly experience devastating disabilities and loss of independence due to impaired movement, paralysis, loss of speech and memory. Randomized clinical data has proven the benefit of mechanical thrombectomy with stent retrievers in helping patients with large vessel occlusion strokes, but these devices have only been indicated to reduce disability if used within six hours of stroke onset.
"For patients presenting with stroke symptoms beyond six hours, the benefit of clot retrieval using a stent retriever was unknown," said Dr. Furlan. "Now we have evidence that for patients who present to the hospital outside of the six hour time window could have a better chance for an independent life with improved clinical outcomes. Although this is great news, earlier treatment is always better because with stroke 'time is brain.'"
The study was supported by Stryker, which produces the Trevo Retriever, a tiny stent-shaped medical device that is attached to a thin wire. The retriever is designed to ensnare the blood clot to remove it from a blood vessel.
UH is working with Case Western Reserve University to develop the Cleveland Brain Health Initiative, linking this kind of leading edge neuroscience work from CWRU, UH, Cleveland Clinic, MetroHealth Medical Center and the Louis Stokes Cleveland VA Medical Center to advance progress therapy and treatment of devastating neurological diseases.
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