title: Partial aortic occlusion for cerebral perfusion augmentation: safety and efficacy of NeuroFlo in Acute Ischemic Stroke trial.
abstract: OBJECTIVE
  Fewer than 5% of patients with acute ischemic stroke are currently treated, and there is need for additional treatment options. A novel catheter treatment (NeuroFlo) that increases cerebral blood flow was tested to 14 hours.
  
  
  METHODS
  The Safety and Efficacy of NeuroFlo in Acute Ischemic Stroke trial is a randomized trial of the safety and efficacy of NeuroFlo treatment in improving neurological outcome versus standard medical management. The primary safety end point was the incidence of serious adverse events through 90 days. The primary efficacy end point on a modified intent-to-treat population was a global disability end point at 90 days. Secondary end points included mortality, intracranial hemorrhage, modified Rankin scale score outcome of 0 to 2, and modified Rankin scale shift analysis.
  
  
  RESULTS
  Between October 2005 and January 2010, 515 patients were enrolled at 68 centers in 9 countries. The primary efficacy end point did not reach statistical significance (OR, 1.17; CI, 0.81-1.67; P=0.407). The primary safety end point did not show a difference in serious adverse events (P=0.923). Ninety-day mortality was 11.3% (26/230) in treatment and 16.3% (42/257) in control (P=0.087). Post hoc analyses showed that patients presenting within 5 hours (OR, 3.33; CI, 1.31-8.48), with NIHSS score 8 to 14 (OR, 1.80; CI, 0.99-3.30), or older than age 70 years (OR, 2.02; CI, 1.02-4.03) had better modified Rankin scale score outcomes of 0 to 2; additionally, there were fewer stroke-related deaths in treatment compared to control groups (7.4% = 17/230; 14.4% = 37/257).
  
  
  CONCLUSIONS
  The trial met its primary safety end point but not its primary efficacy end point. Signals of treatment effect were suggested on all-cause mortality, in patients presenting early, older than age 70 years, or with moderate strokes, but these require confirmation.
  
  
  BACKGROUND
  URL: http://clinicaltrials.gov. Unique identifier: NCT00119717.
authors.affiliation: Stroke Program, University of Alberta, Canada. ashfaq.shuaib@ualberta.ca
authors.forename: Ashfaq
authors.initials: A
authors.lastname: Shuaib
authors.forename: Natan M
authors.initials: NM
authors.lastname: Bornstein
authors.forename: Hans-Christoph
authors.initials: HC
authors.lastname: Diener
authors.forename: William
authors.initials: W
authors.lastname: Dillon
authors.forename: Marc
authors.initials: M
authors.lastname: Fisher
authors.forename: Maxim D
authors.initials: MD
authors.lastname: Hammer
authors.forename: Carlos A
authors.initials: CA
authors.lastname: Molina
authors.forename: J Neal
authors.initials: JN
authors.lastname: Rutledge
authors.forename: Jeffrey L
authors.initials: JL
authors.lastname: Saver
authors.forename: Peter D
authors.initials: PD
authors.lastname: Schellinger
authors.forename: Harish
authors.initials: H
authors.lastname: Shownkeen
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001011:Aorta / Q000503:physiopathology*; D002545:Brain Ischemia / Q000628:therapy*; D002404:Catheterization / Q000379:methods; D057785:Catheters; D002560:Cerebrovascular Circulation / Q000502:physiology*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D016037:Single-Blind Method; D020521:Stroke / Q000628:therapy*; D016896:Treatment Outcome