Covidien has announced the launch of a new study SWIFT PRIME (Solitaire FR as primary treatment for acute ischaemic stroke), which has enrolled its first patient at the University at Buffalo, USA. The new multicentre, randomised controlled trial will be one of the largest global studies to examine the adjunctive use of mechanical thrombectomy during the early stages of acute ischaemic stroke onset.
Covidien’s Solitaire FR Revascularisation Device will be used in the SWIFT PRIME study.
The SWIFT PRIME study, according to the company, intends to examine acute ischaemic stroke patients treated with either intravenous tissue plasminogen activator (IV tPA) alone or IV tPA in combination with the Solitaire FR device. The study will also include an extensive health economics analysis.
“The launch of the SWIFT PRIME trial is an important milestone in the evolution of stroke therapeutics,” said Jeffrey L Saver, professor of Neurology, Geffen School of Medicine and director of University of California Los Angeles, Comprehensive Stroke Center, USA. “The goal of this international randomised trial is to demonstrate definitively the benefit of stent retriever therapy with the Solitaire FR device in patients with acute ischaemic stroke.”
Saver is co-leader of the study alongside Elad I Levy, professor of Neurosurgery and Radiology, University at Buffalo, USA. Levy added, “SWIFT PRIME is the first multicentre 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.”
The study may enrol up to 800 patients across 60 centres globally. Hans-Christoph Diener, professor of Neurology, University of Essen, Germany, and Vitor Mendes Pereira, director of Interventional Neuroradiology Division (Médecin Adjoint Responsible d’Unité), Service de Neuroradiologie, University Hospital of Geneva, Switzerland, will serve as the European principal investigator and European Interventional principal investigator, respectively.
“Technological innovation in mechanical thrombectomy represents one of the most promising new developments in stroke treatment,” said Mark Turco, chief medical officer, Covidien Vascular Therapies. “The Solitaire FR, an advanced stroke device, shows substantial improvements in outcomes over previous mechanical thrombectomy treatments. The SWIFT PRIME study is an important step in assessing both the clinical and economic value of our newest innovation in this area, underscoring Covidien’s commitment to the advancement of stroke care. We also look forward to the insights that the study will provide into critical components of stroke treatment, such as time and imaging.”
The Solitaire FR device received CE mark approval in 2009 and US Food and Drug Administration 510(k) marketing clearance in 2012.