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October 6, 2009
Penumbra Enrolls First Patient in the START Trial
October 7, 2009—Penumbra, Inc. (Alameda, CA) announced the commencement of the START (Stroke Treatment and Revascularization Therapy) trial, which aims to correlate clinical outcome after acute stroke intervention to pragmatic image-guided patient selection criteria. The START trial is an open-label, prospective, single-arm, multicenter outcome trial of severe (National Institutes of Health Stroke Scale = 10) large-vessel ischemic stroke in the anterior circulation with known infarct size on admission. Patients must be enrolled less than 8 hours from symptom onset. A central core lab headquartered at Massachusetts General Hospital in Boston will read all imaging data. The first patient was enrolled by the stroke team at the Medical University of South Carolina in Charleston.
"The START trial is the beginning of a scientific process to understand which acute stroke patients will benefit most from interventional therapeutic procedures," commented Aquilla Turk, DO, a radiologist on the South Carolina stroke team. "The entire stroke team, including neurointerventional physicians, often put a tremendous amount of organizational and personal effort into treating this emergency disease 24 hours per day. Using noninvasive imaging to quickly understand which patients are likely to have a good recovery will allow us to treat this devastating condition much more efficiently and aggressively."
R. Gilberto Gonzalez, MD, who is Director of Neuroradiology at Massachusetts General Hospital, added, "The use of noninvasive imaging for assessment of acute stroke patients has been a controversial topic for many years. To date, a pragmatic, easily implemented imaging criterion has not been studied and validated for widespread clinical use. The START trial proposes to look at this issue in a rigorous way. Looking at the relevance of pretreatment infarct core to good functional outcome may reveal just such a clinically useful criterion."
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