title: A multicenter, randomized, controlled study to investigate EXtending the time for Thrombolysis in Emergency Neurological Deficits with Intra-Arterial therapy (EXTEND-IA).
abstract: OBJECTIVE
  Thrombolysis with tissue plasminogen activator is proven to reduce disability when given within 4·5 h of ischemic stroke onset. However, tissue plasminogen activator only succeeds in recanalizing large vessel arterial occlusion in a minority of patients. We hypothesized that anterior circulation ischemic stroke patients, selected with 'dual target' vessel occlusion and evidence of salvageable brain using computed tomography or magnetic resonance imaging 'mismatch' within 4·5 h of onset, would have improved reperfusion and early neurological improvement when treated with intra-arterial clot retrieval after intravenous tissue plasminogen activator compared with intravenous tissue plasminogen activator alone.
  
  
  METHODS
  EXTEND-IA is an investigator-initiated, phase II, multicenter prospective, randomized, open-label, blinded-endpoint study. Ischemic stroke patients receiving standard 0·9 mg/kg intravenous tissue plasminogen activator within 4·5 h of stroke onset who have good prestroke functional status (modified Rankin Scale <2, no upper age limit) will undergo multimodal computed tomography or magnetic resonance imaging. Patients who also meet dual target imaging criteria: vessel occlusion (internal carotid or middle cerebral artery) and mismatch (perfusion lesion : ischemic core mismatch ratio >1·2, absolute mismatch >10 ml, ischemic core volume <70 ml) will be randomized to either clot retrieval with the Solitaire FR device after full dose intravenous tissue plasminogen activator, or tissue plasminogen activator alone.
  
  
  RESULTS
  The coprimary outcome measure will be reperfusion at 24 h and favorable clinical response (reduction in National Institutes of Health Stroke Scale by ≥8 points or reaching 0-1) at day 3. Secondary outcomes include modified Rankin Scale at day 90, death, and symptomatic intracranial hemorrhage.
authors.affiliation: Department of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia.
authors.forename: Bruce C V
authors.initials: BC
authors.lastname: Campbell
authors.forename: Peter J
authors.initials: PJ
authors.lastname: Mitchell
authors.forename: Bernard
authors.initials: B
authors.lastname: Yan
authors.forename: Mark W
authors.initials: MW
authors.lastname: Parsons
authors.forename: Søren
authors.initials: S
authors.lastname: Christensen
authors.forename: Leonid
authors.initials: L
authors.lastname: Churilov
authors.forename: Richard J
authors.initials: RJ
authors.lastname: Dowling
authors.forename: Helen
authors.initials: H
authors.lastname: Dewey
authors.forename: Mark
authors.initials: M
authors.lastname: Brooks
authors.forename: Ferdinand
authors.initials: F
authors.lastname: Miteff
authors.forename: Christopher
authors.initials: C
authors.lastname: Levi
authors.forename: Martin
authors.initials: M
authors.lastname: Krause
authors.forename: Timothy J
authors.initials: TJ
authors.lastname: Harrington
authors.forename: Kenneth C
authors.initials: KC
authors.lastname: Faulder
authors.forename: Brendan S
authors.initials: BS
authors.lastname: Steinfort
authors.forename: Timothy
authors.initials: T
authors.lastname: Kleinig
authors.forename: Rebecca
authors.initials: R
authors.lastname: Scroop
authors.forename: Steve
authors.initials: S
authors.lastname: Chryssidis
authors.forename: Alan
authors.initials: A
authors.lastname: Barber
authors.forename: Ayton
authors.initials: A
authors.lastname: Hope
authors.forename: Maurice
authors.initials: M
authors.lastname: Moriarty
authors.forename: Ben
authors.initials: B
authors.lastname: McGuinness
authors.forename: Andrew A
authors.initials: AA
authors.lastname: Wong
authors.forename: Alan
authors.initials: A
authors.lastname: Coulthard
authors.forename: Tissa
authors.initials: T
authors.lastname: Wijeratne
authors.forename: Andrew
authors.initials: A
authors.lastname: Lee
authors.forename: Jim
authors.initials: J
authors.lastname: Jannes
authors.forename: James
authors.initials: J
authors.lastname: Leyden
authors.forename: Thanh G
authors.initials: TG
authors.lastname: Phan
authors.forename: Winston
authors.initials: W
authors.lastname: Chong
authors.forename: Michael E
authors.initials: ME
authors.lastname: Holt
authors.forename: Ronil V
authors.initials: RV
authors.lastname: Chandra
authors.forename: Christopher F
authors.initials: CF
authors.lastname: Bladin
authors.forename: Monica
authors.initials: M
authors.lastname: Badve
authors.forename: Henry
authors.initials: H
authors.lastname: Rice
authors.forename: Laetitia
authors.initials: L
authors.lastname: de Villiers
authors.forename: Henry
authors.initials: H
authors.lastname: Ma
authors.forename: Patricia M
authors.initials: PM
authors.lastname: Desmond
authors.forename: Geoffrey A
authors.initials: GA
authors.lastname: Donnan
authors.forename: Stephen M
authors.initials: SM
authors.lastname: Davis
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D005343:Fibrinolytic Agents / Q000627:therapeutic use; D006801:Humans; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D064847:Multimodal Imaging; D012107:Research Design; D020521:Stroke / Q000628:therapy*; D017131:Thrombectomy / Q000379:methods*; D015912:Thrombolytic Therapy / Q000379:methods*; D010959:Tissue Plasminogen Activator / Q000627:therapeutic use; D014057:Tomography, X-Ray Computed; D055815:Young Adult
chemical_list: D005343:Fibrinolytic Agents; D010959:Tissue Plasminogen Activator
keywords: CT perfusion; intra-arterial therapy; ischemic stroke; mechanical clot retrieval; solitaire stentriever device; thrombolysis