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

J. L. Saver, R. Jahan, E. I. Levy, T. G. Jovin, B. Baxter, R. Nogueira, W. Clark, R. Budzik, O. O. Zaidat

Research output: Contribution to journalArticle

45 Scopus citations

Abstract

Rationale: 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. Aims: (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. Study Procedures: 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 8h 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. Outcomes: 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.

Original languageEnglish (US)
Pages (from-to)658-668
Number of pages11
JournalInternational Journal of Stroke
Volume9
Issue number5
DOIs
StatePublished - Jul 2014

Keywords

  • Acute ischaemic stroke
  • Clinical trial
  • Endovascular
  • Recanalization
  • Stent retriever
  • Thrombolysis

ASJC Scopus subject areas

  • Neurology

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