Aphase III, randomized, multi-center, open label, 900 subject clinical trial that will examine whether a combined intravenous (IV) and intra-arterial (IA) approach to recanalization is superior to standard IV rt-PA (Activase®) alone when initiated within three hours of acute ischemic stroke onset.

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The Interventional Management of Stroke (IMS III) Trial is a randomized, open-label multi-center study that will compare a combined intravenous (IV) and intra-arterial (IA) treatment approach to restoring blood flow to the brain to the current standard FDA approved treatment approach of giving IV rt-PA alteplase, Activase,® alone. Both approaches must have treatment initiated within three hours of stroke onset. A projected 900 subjects with moderate to severe ischemic stroke (a baseline NIH Stroke Scale Score ≥ 10) and who are ages 18-80 will be enrolled at 40+ centers in the United States and Canada.

The primary measure of outcome in this trial is a favorable outcome in terms of functional independence as measured by a Modified Rankin Scale score of 0-2 at 3 months. The trial is designed to test whether there is an overall absolute difference of at least 10% in the proportion of a favorable outcomes for subjects treated with the combined IV/IA approach as compared to those treated with the IV rt-PA only approach. The IMS III Trial will also evaluate the effectiveness of the combined IV/IA approach compared to the IV rt-PA therapy alone by a number of secondary outcome measures. These include: 1) the Barthel Index, Glasgow Outcome Scale, NIHSS, EuroQol, and Trailmaking Test at 3 months, 2) an improved early response to treatment as determined by an NIHSSS of 0-2 at 24 hours, 3) a CT angiography assessment of intracranial vascular patency at 24 hours (both treatment groups), 4) the volume of cerebral infarction as measured by a CT scan at 24 +/- 6 hours from onset. 5) We will also measure the rate of TICI Grade II or III perfusion flow and recanalization of the primary arterial occlusion at completion of angiography (combined IV/IA group only).

• compare the safety of a combined IV/IA approach to IV rt-PA alone.
• determine the cost effectiveness of the combined IV/IA approach as compared to standard IV rt-PA as measured by differences in utilization of resources and quality of life over 12 months between the two arms of the trial.
• develop and maintain a network of interventional centers to test the efficacy and safety of a combined IV/IA approach to opening blocked vessel and restoring blood flow to the brain.