title: 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).
abstract: BACKGROUND
  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.
  
  
  OBJECTIVE
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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).
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Neurosurgery, University at Buffalo, State University of New York, Buffalo, NY, USA. elevy@ubns.com
authors.forename: Elad I
authors.initials: EI
authors.lastname: Levy
authors.forename: Maryam
authors.initials: M
authors.lastname: Rahman
authors.forename: Alexander A
authors.initials: AA
authors.lastname: Khalessi
authors.forename: Patrick T
authors.initials: PT
authors.lastname: Beyer
authors.forename: Sabareesh K
authors.initials: SK
authors.lastname: Natarajan
authors.forename: Mary L
authors.initials: ML
authors.lastname: Hartney
authors.forename: David J
authors.initials: DJ
authors.lastname: Fiorella
authors.forename: L Nelson
authors.initials: LN
authors.lastname: Hopkins
authors.forename: Adnan H
authors.initials: AH
authors.lastname: Siddiqui
authors.forename: J
authors.initials: J
authors.lastname: Mocco
mesh_terms: D017130:Angioplasty / Q000009:adverse effects* / Q000295:instrumentation*; D002533:Cerebral Angiography; D006801:Humans; D011183:Postoperative Complications / Q000453:epidemiology*; D015607:Stents; D020521:Stroke / Q000601:surgery*; D014481:United States; D014486:United States Food and Drug Administration