CLINICAL TRIAL
COMPARATIVE STUDY
JOURNAL ARTICLE
MULTICENTER STUDY
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First Food and Drug Administration-approved prospective trial of primary intracranial stenting for acute stroke: SARIS (stent-assisted recanalization in acute ischemic stroke).

BACKGROUND AND PURPOSE: Acute revascularization is associated with improved outcomes in ischemic stroke patients. However, it is unclear which method of intraarterial intervention, if any, is ideal. Numerous case series and cardiac literature parallels suggest that acute stenting may yield high revascularization levels with low associated morbidity. We therefore conducted a Food and Drug Administration-approved prospective pilot trial to evaluate the safety of intracranial stenting for acute ischemic stroke.

METHODS: Eligibility criteria included presentation or=8, angiographic demonstration of focal intracerebral artery occlusion
RESULTS: Twenty patients were enrolled (mean age, 63+/-18 years;14 women). Mean presenting National Institutes of Health Stroke Scale was 14+/-3.8 (median 13). Presenting thrombolysis in myocardial infarction score was 0 (85% of patients) or 1 (15%). Recanalization to thrombolysis in myocardial infarction score of 3 (60% of patients) or 2 (40% of patients; P<0.0001) was achieved. One (5%) symptomatic and 2 (10%) asymptomatic intracranial hemorrhages occurred. At 1-month follow-up, a modified Rankin scale score of
CONCLUSIONS: This Food and Drug Administration-approved prospective study suggests primary intracranial stenting for acute stroke may be a valuable addition to the stroke treatment armamentarium.

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