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Neurosurgery. 2011 Oct;69(4):915-20; discussion 920. doi: 10.1227/NEU.0b013e318222afd1.

Midterm clinical and angiographic follow-up for the first Food and Drug Administration-approved prospective, Single-Arm Trial of Primary Stenting for Stroke: SARIS (Stent-Assisted Recanalization for Acute Ischemic Stroke).

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Department of Neurosurgery, University at Buffalo, State University of New York, Buffalo, NY, USA.



Although early data demonstrate encouraging angiographic results following intracranial stent deployment for acute ischemic stroke, longer-term follow-up is necessary to evaluate the clinical outcomes, as well as the durability of angiographic results.


We report 6-month clinical and radiologic follow-up data of the 20 patients prospectively enrolled in the Stent-Assisted Recanalization in acute Ischemic Stroke (SARIS) trial.


Twenty patients were prospectively enrolled to receive self-expanding intra-arterial stents as first-line therapy for acute ischemic stroke treatment. Patients were scheduled for follow-up 6-months after treatment for clinical evaluation (modified Rankin Scale [mRS] score obtained by a trained certified research nurse/nurse practitioner) and repeat cerebral angiography. Angiographic interpretation was performed by an independent adjudicator.


At 6 months, the mRS score was ≤3 in 60% of patients (n = 12) and was ≤2 in 55% of patients (n = 11). Mortality at the 6-month follow-up was 35% (n = 7). Follow-up angiography was performed for 85% (11 of 13) of surviving patients. All patients undergoing angiographic follow-up demonstrated Thrombolysis in Myocardial Infarction 3 flow on digital subtraction angiography or stent patency on computed tomographic angiography. None of the patients demonstrated evidence of in-stent stenosis (≥50% vessel narrowing).


The midterm angiographic and clinical results following intracranial stent deployment for acute ischemic stroke are encouraging. Further study of primary stent-for-stroke treatment is warranted.

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