England National Institute for Health Research Stroke Research Network Adopts Gore REDUCE Clinical Study
Study Investigates Device Closure of Patent Foramen Ovale (PFO) in Stroke Reduction
W. L. Gore & Associates (Gore) today announced that the National Institute for Health Research Stroke Research Network has adopted the Gore REDUCE Clinical Study to help drive patient recruitment across England. The Gore REDUCE Clinical Study is designed to demonstrate that Patent Foramen Ovale (PFO) closure with the GORE® Septal Occluder plus antiplatelet medical management reduces the risk of recurrent stroke or imaging-confirmed transient ischemic attack (TIA) when compared to antiplatelet medical management alone in patients with a PFO and history of cryptogenic stroke or imaging-confirmed TIA. The prospective, randomized, multi-center, multi-national trial will include up to eighty investigational sites in the US, Europe and Canada.
The National Institute for Health Research Stroke Research Network supports vital stroke studies such as the Gore REDUCE Clinical Study by providing coordination, leadership and practical help. It supports both academic research and industry-sponsored studies, offering 100 percent coverage of the National Health Service hospitals nationwide. Established in 2006, the network has increased patient recruitment six-fold. It also provides a patient and career involvement program that aims to make a real impact on both the quality and delivery of stroke research.
“PFO closure is known as a low-risk treatment, therefore; patient enrollment remains a challenge for all closure studies because many patients are not willing to be randomized,” said David Hildick-Smith, MD, Director of Cardiac Research Unit, Brighton and Sussex University Hospitals and investigator in the trial. “Stroke Research Network adoption of REDUCE will help drive recruitment in this pivotal trial thus resolving this all too common issue. REDUCE is being run with Gore’s customary attention to detail and I expect it to be a high quality and well respected trial.
”Patients in the Gore REDUCE Clinical Study are randomized to one of two treatment arms, either anti-platelet medical management alone or device closure of the PFO in conjunction with anti-platelet medical management. The primary endpoint is freedom from recurrent ischemic stroke, imaging confirmed TIA, or death due to stroke through 24 months post-randomization.
Philip Bath, Industry Director for the National Institute for Health Research’s Stroke Research Network stated, “The Stroke Research Network is very pleased to be supporting Gore in delivering their study which has the potential to benefit NHS patients if the device reduces stroke recurrence, and therefore support the health and wealth of the UK.”
“Gore is committed to completing this study and reducing incidences of stroke,” said Stuart Broyles, PhD, Associate with the Gore Medical Division Stroke Business. “The support of the Stroke Research Network brings us one step closer to this goal.”