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, Wayne Clark, R. Budzik, O. O. Zaidat

Research output: Contribution to journalArticle

42 Citations (Scopus)

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

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

Fingerprint

Thrombectomy
Multicenter Studies
Stroke
Equipment and Supplies
National Institutes of Health (U.S.)
Brain Ischemia
Stents
Randomized Controlled Trials
Safety

Keywords

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

ASJC Scopus subject areas

  • Neurology
  • Medicine(all)

Cite this

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

In: International Journal of Stroke, Vol. 9, No. 5, 2014, p. 658-668.

Research output: Contribution to journalArticle

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