Covidien has announced the launch of a new study, so-called SWIFT PRIME, which enrolled its first patient at the University at Buffalo. The new multi-centre, 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 ischemic stroke onset.
Acute ischemic stroke occurs when a clot in a blood vessel blocks blood supply to the brain. According to the American Heart Association, acute ischemic stroke is the leading cause of disability and the fourth most common cause of death in the United States.
The SWIFT PRIME study will examine acute ischemic stroke patients treated with either intravenous tissue plasminogen activator (IV tPA) alone or IV tPA in combination with Covidien’s Solitaire™ FR Revascularisation Device, an overlapping stent-based technology that the company says provides substantially improved clinical outcomes to the previous generation of devices.
The study may enroll up to 800 patients across 60 centres globally and will 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, MD, FAHA, FAAN, Professor of Neurology, Geffen School of Medicine at UCLA and Director, UCLA Comprehensive Stroke Center. “The goal of this international randomised trial is to demonstrate definitively the benefit of stent retriever therapy with the Solitaire FR Revascularization Device in patients with acute ischemic stroke.”
Dr. Saver is co-leading the study with Elad I. Levy, MD, FACS, FAHA, Professor of Neurosurgery and Radiology, University at Buffalo and Director of Interventional Stroke Services, Director of Endovascular Neurosurgery Fellowship Education and Co-Director for Stroke, Kaleida Health.
Dr. Levy added, “SWIFT PRIME is the first multi-centre 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.”
“Technological innovation in mechanical thrombectomy represents one of the most promising new developments in stroke treatment,” said Dr. 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 that will be used in the trial received U.S. FDA 510(k) marketing clearance in 2012 and CE Mark approval in 2009.