Methodology of the Interventional Management of Stroke III Trial.

International Journal of Stroke : Official Journal of the International Stroke Society
Pooja KhatriInterventional Management of Stroke III Investigators

Abstract

The Interventional Management of Stroke (IMS) I and II pilot trials demonstrated that the combined intravenous (i.v.) and intraarterial (i.a.) approach to recanalization may be more effective than standard i.v. rt-PA (Activase) alone for moderate-to-large National Institutes of Health Stroke Scale (NIHSS>or=10) strokes, and with a similar safety profile. The primary objective of this NIH-funded, Phase III, randomized, multicenter, open-label clinical trial is to determine whether a combined i.v./i.a. approach to recanalization is superior to standard i.v. rt-PA alone when initiated within 3 h of acute ischemic stroke onset. The IMS III trial will develop and maintain a network of interventional centers to test the safety, feasibility, and potential efficacy of new FDA-approved catheter devices as part of a combined i.v./i.a. approach to recanalization as the IMS III study progresses. A secondary objective of the IMS III trial is to determine the cost-effectiveness of the combined i.v./i.a. approach as compared with standard i.v. rt-PA. Trial enrollment began in July of 2006. A projected 900 subjects with moderate-to-large (NIHSS>or=10) ischemic strokes between ages 18 and 80 will be enrolled over the next 5 years at 40-plus cen...Continue Reading

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BETA
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[UNK] SQL Server

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