title: Thrombectomy in patients ineligible for iv tPA (THRILL).
abstract: BACKGROUND
  A relevant proportion of patients with acute ischemic stroke are ineligible for intravenous thrombolysis with recombinant tissue plasminogen activator. Mechanical thrombectomy offers a treatment alternative for these patients; however, only few data are available on its safety and efficacy.
  
  
  OBJECTIVE
  The aim of this study was to compare safety and efficacy of stent retrievers as device class with best medical care alone in acute stroke patients with large intracranial vessel occlusion in the anterior circulation who are not eligible for intravenous thrombolysis with recombinant tissue plasminogen activator up to eight-hours of symptom onset.
  
  
  METHODS
  'Thrombectomy in patients ineligible for iv tPA' is a prospective, open-label, blinded end-point, binational (Germany and Austria), two-arm, randomized, controlled, post-market study.
  Primary end-point is the modified Rankin Score shift analysis 90 days (±14) after stroke. Secondary end-points are excellent neurological outcomes (modified Rankin Score ≤ 1), good neurological outcomes (modified Rankin Score ≤ 2 or National Institutes of Health Stroke Scale improvement ≥ 10), difference between predicted infarct volume and actual core infarct volume (computed tomography or magnetic resonance imaging) at 30 (±6) h post-ictus, successful recanalization (thrombolysis in cerebral infarction score 2b or 3), functional health status 90 (±14) days after stroke (European Quality of Life-5 Dimensions) as well as common safety end-points (adverse event, serious adverse event, symptomatic intracranial haemorrhage at 30 (±6) h, death, or dependency).
  
  
  CONCLUSIONS
  Whether mechanical thrombectomy in patients with acute ischemic stroke who are not eligible for intravenous thrombolysis with recombinant tissue plasminogen activator improves clinical outcomes is unclear. 'Thrombectomy in patients ineligible for iv tPA' may change clinical practice by providing evidence of an effective and safe treatment for such patients.
authors.affiliation: Neuroradiology, University of Heidelberg, Heidelberg, Germany.
authors.forename: Martin
authors.initials: M
authors.lastname: Bendszus
authors.affiliation: Department of Neurology, University Medical Center Hamburg-Eppendorf (UKE), Hamburg, Germany.
authors.forename: Götz
authors.initials: G
authors.lastname: Thomalla
authors.affiliation: Neuroradiology, University Medicine Goettingen, Goettingen, Germany.
authors.forename: Michael
authors.initials: M
authors.lastname: Knauth
authors.affiliation: Neurology, Ruprecht-Karls-University of Heidelberg, Heidelberg, Germany.
authors.forename: Werner
authors.initials: W
authors.lastname: Hacke
authors.affiliation: Neuroradiology, University of Heidelberg, Heidelberg, Germany.
authors.forename: Susanne
authors.initials: S
authors.lastname: Bonekamp
authors.affiliation: Neurology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
authors.forename: Jens
authors.initials: J
authors.lastname: Fiehler
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001317:Austria; D002545:Brain Ischemia / Q000601:surgery*; D005858:Germany; D006801:Humans; D008875:Middle Aged; D011446:Prospective Studies; D012720:Severity of Illness Index; D016037:Single-Blind Method; D015607:Stents / Q000009:adverse effects; D020521:Stroke / Q000601:surgery*; D017131:Thrombectomy / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
keywords: acute stroke therapy; clinical trial; intervention; ischemic stroke; tPA; treatment