Covidien Commences Enrollment for SWIFT PRIME Acute Ischemic Stroke Study

January 14, 2013—Covidien (Mansfield, MA) announced the launch of the SWIFT PRIME study, a multicenter, randomized controlled trial that will examine the adjunctive use of mechanical thrombectomy during the early stages of acute ischemic stroke onset.

The SWIFT PRIME study will evaluate acute ischemic stroke patients treated with intravenous tissue plasminogen activator, either alone or in combination with Covidien's Solitaire FR revascularization device. The study will also include an extensive health economics analysis. The Solitaire FR device, which is an overlapping stent-based technology, received US Food and Drug Administration 510(k) marketing clearance in 2012 and European CE Mark approval in 2009, advised Covidien.

The coleaders of the SWIFT PRIME trial are Jeffrey L. Saver, MD, and Elad I. Levy, MD. Dr. Saver is Professor of Neurology at the Geffen School of Medicine at the University of California, Los Angeles (UCLA) and Director, UCLA Comprehensive Stroke Center. Dr. Levy is Professor of Neurosurgery and Radiology at the University at Buffalo, State University of New York, and Director of Interventional Stroke Services, Director of Endovascular Neurosurgery Fellowship Education, and Codirector for Stroke at Kaleida Health. The first patient in the SWIFT PRIME trial was enrolled at the University at Buffalo.

“The launch of the SWIFT PRIME trial is an important milestone in the evolution of stroke therapeutics,” commented Dr. Saver in Covidien's press release. “The goal of this international randomized trial is to demonstrate definitively the benefit of stent retriever therapy with the Solitaire FR Revascularization Device in patients with acute ischemic stroke.”

Dr. Levy added, “SWIFT PRIME is the first multicenter prospective study that studies brain physiology when selecting patients for stent retriever treatment. We hope this study will help better understand the patient population that most benefits from thrombolysis combined with mechanical thrombectomy.”

In its announcement, Covidien also stated that the SWIFT PRIME study may enroll up to 800 patients across 60 centers globally. Prof. Hans-Christoph Diener, MD, and Prof. Vitor Mendes Pereira, MD, will serve as the European Principal Investigator and European Interventional Principal Investigator, respectively.

Prof. Diener is Professor of Neurology and Chairman of the Department of Neurology at the University of Essen, Chairman of the Essen Stroke Center, and Co-Chair of the Neurological Rehabilitation Unit, Department of Neurology, University Hospital Essen in Germany. Prof. Mendes Pereira is Director of Interventional Neuroradiology Division (Médecin Adjoint Responsible d'Unité), Service de Neuroradiologie, University Hospital of Geneva in Switzerland.