title: MR CLEAN, a multicenter randomized clinical trial of endovascular treatment for acute ischemic stroke in the Netherlands: study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Endovascular or intra-arterial treatment (IAT) increases the likelihood of recanalization in patients with acute ischemic stroke caused by a proximal intracranial arterial occlusion. However, a beneficial effect of IAT on functional recovery in patients with acute ischemic stroke remains unproven. The aim of this study is to assess the effect of IAT on functional outcome in patients with acute ischemic stroke. Additionally, we aim to assess the safety of IAT, and the effect on recanalization of different mechanical treatment modalities.
  
  
  METHODS
  A multicenter randomized clinical trial with blinded outcome assessment. The active comparison is IAT versus no IAT. IAT may consist of intra-arterial thrombolysis with alteplase or urokinase, mechanical treatment or both. Mechanical treatment refers to retraction, aspiration, sonolysis, or use of a retrievable stent (stent-retriever). Patients with a relevant intracranial proximal arterial occlusion of the anterior circulation, who can be treated within 6 hours after stroke onset, are eligible. Treatment effect will be estimated with ordinal logistic regression (shift analysis); 500 patients will be included in the trial for a power of 80% to detect a shift leading to a decrease in dependency in 10% of treated patients. The primary outcome is the score on the modified Rankin scale at 90 days. Secondary outcomes are the National Institutes of Health stroke scale score at 24 hours, vessel patency at 24 hours, infarct size on day 5, and the occurrence of major bleeding during the first 5 days.
  
  
  CONCLUSIONS
  If IAT leads to a 10% absolute reduction in poor outcome after stroke, careful implementation of the intervention could save approximately 1% of all new stroke cases from death or disability annually.
  
  
  BACKGROUND
  NTR1804 (7 May 2009)/ISRCTN10888758 (24 July 2012).
authors.forename: Puck S S
authors.initials: PS
authors.lastname: Fransen
authors.forename: Debbie
authors.initials: D
authors.lastname: Beumer
authors.forename: Olvert A
authors.initials: OA
authors.lastname: Berkhemer
authors.forename: Lucie A
authors.initials: LA
authors.lastname: van den Berg
authors.forename: Hester
authors.initials: H
authors.lastname: Lingsma
authors.forename: Aad
authors.initials: A
authors.lastname: van der Lugt
authors.forename: Wim H
authors.initials: WH
authors.lastname: van Zwam
authors.forename: Robert J
authors.initials: RJ
authors.lastname: van Oostenbrugge
authors.forename: Yvo B W E M
authors.initials: YB
authors.lastname: Roos
authors.forename: Charles B
authors.initials: CB
authors.lastname: Majoie
authors.affiliation: Department of Neurology, Erasmus MC University Medical Center, PO Box 2040, 3000 CA, Rotterdam, the Netherlands. d.dippel@erasmusmc.nl.
authors.forename: Diederik W J
authors.initials: DW
authors.lastname: Dippel
mesh_terms: D002545:Brain Ischemia / Q000601:surgery*; D002985:Clinical Protocols; D057510:Endovascular Procedures; D006801:Humans; D018401:Sample Size; D020521:Stroke / Q000601:surgery*