title: SOLITAIRE™ with the intention for thrombectomy (SWIFT) trial: design of a randomized, controlled, multicenter study comparing the SOLITAIRE™ Flow Restoration device and the MERCI Retriever in acute ischaemic stroke.
abstract: BACKGROUND
  Self-expanding stent retrievers are a promising new device class designed for rapid flow restoration in acute cerebral ischaemia. The SOLITAIRE™ Flow Restoration device (SOLITAIRE) has shown high rates of recanalization in preclinical models and in uncontrolled clinical series.
  
  
  OBJECTIVE
  (1) To demonstrate non-inferiority of SOLITAIRE compared with a legally marketed device, the MERCI Retrieval System®; (2) To demonstrate safety, feasibility, and efficacy of SOLITAIRE in subjects requiring mechanical thrombectomy diagnosed with acute ischaemic stroke. DESIGN : Multicenter, randomized, prospective, controlled trial with blinded primary end-point ascertainment.
  Key entry criteria include: age 22-85; National Institute of Health Stroke Scale (NIHSS) ≥8 and <30; clinical and imaging findings consistent with acute ischaemic stroke; patient ineligible or failed intravenous tissue plasminogen activator; accessible occlusion in M1 or M2 middle cerebral artery, internal carotid artery, basilar artery, or vertebral artery; and patient able to be treated within 8 h of onset. Sites first participate in a roll-in phase, treating two patients with the SOLITAIRE device, before proceeding to the randomized phase. In patients unresponsive to the initially assigned therapy, after the angiographic component of the primary end-point is ascertained (reperfusion with the initial assigned device), rescue therapy with other reperfusion techniques is permitted.
  
  
  RESULTS
  The primary efficacy end-point is successful recanalization with the assigned study device (no use of rescue therapy) and with no symptomatic intracranial haemorrhage. Successful recanalization is defined as achieving Thrombolysis In Myocardial Ischemia 2 or 3 flow in all treatable vessels. The primary safety end-point is the incidence of device-related and procedure-related serious adverse events. A major secondary efficacy end-point is time to achieve initial recanalization. Additional secondary end-points include clinical outcomes at 90 days and radiologic haemorrhagic transformation.
authors.affiliation: Department of Neurology and Stroke Center, UCLA, Los Angeles, California, USA.
authors.forename: J L
authors.initials: JL
authors.lastname: Saver
authors.forename: R
authors.initials: R
authors.lastname: Jahan
authors.forename: E I
authors.initials: EI
authors.lastname: Levy
authors.forename: T G
authors.initials: TG
authors.lastname: Jovin
authors.forename: B
authors.initials: B
authors.lastname: Baxter
authors.forename: R
authors.initials: R
authors.lastname: Nogueira
authors.forename: W
authors.initials: W
authors.lastname: Clark
authors.forename: R
authors.initials: R
authors.lastname: Budzik
authors.forename: O O
authors.initials: OO
authors.lastname: Zaidat
mesh_terms: D001921:Brain / Q000000981:diagnostic imaging / Q000601:surgery; D002545:Brain Ischemia / Q000000981:diagnostic imaging / Q000601:surgery*; D002985:Clinical Protocols; D006801:Humans; D017063:Outcome Assessment, Health Care / Q000379:methods; D018579:Patient Selection; D011446:Prospective Studies; D011859:Radiography; D015607:Stents / Q000009:adverse effects; D020521:Stroke / Q000000981:diagnostic imaging / Q000601:surgery*; D017131:Thrombectomy / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods
keywords: acute ischaemic stroke; clinical trial; endovascular; recanalization; stent retriever; thrombolysis