Gore joined the US principal investigators for the Gore REDUCE Clinical Study in reaffirming their commitment to the study of Patent Foramen Ovale (PFO) in stroke patients using the Gore Helex Septal Occluder on 15 November 2010. The statement of commitment comes on the heels of results made public today in the CLOSURE I trial announced at the American Heart Association’s Scientific Sessions 2010.
In addition, Gore announced the launch of www.clinical.goremedical.com/REDUCE, a website intended as a resource for patients, families and physicians looking for more information about the Gore REDUCE clinical study. By launching this site Gore hopes to spur patient enrolment in the GORE REDUCE clinical study by providing support for both the patient and physician community working to address PFO.
Scott Kasner, professor of Neurology and director of the Comprehensive Stroke Center at the University of Pennsylvania Medical Center, and US neurology principal investigator for the Gore REDUCE Clinical Study, commented recently on the differences between the Gore REDUCE Clinical Study when compared to others, as well as on the expected successful outcome of the study.
Kasner stated, “The design of the Gore REDUCE Clinical Study is unique from the other PFO stroke trials in several respects. First, magnetic resonance imaging (MRI) of the brain will be performed on all patients at baseline and at two years. This feature offers an additional imaging endpoint for making comparisons between the treatment arms. Second, it focuses on secondary prevention of stroke rather than transient ischaemic attack, which improves the reliability and validity of the study outcomes and measurably impacts the public health. Finally, this is a multinational study, which enhances its global applicability. These efforts will likely help resolve the still unresolved debate about whether PFO closure is an effective option for treating cryptogenic stroke/ transient ischaemic attack patients as compared to medical treatment alone.”
According to John Rhodes, chief of The Congenital Heart Center, Duke University Medical Center, US cardiology principal investigator for the Gore REDUCE Clinical Study, “Gore’s study seeks to overcome the shortcomings of CLOSURE I and allow us to draw clear conclusions about whether PFO closure significantly reduces recurrent embolic events as compared to medical treatment, such as aspirin and other antiplatelet therapies. Notably, the Gore REDUCE Clinical Study is focused on a newer device with key differences that may make it more effective for successful PFO closure. Residual leaks, the device material, and inclusion of minor neurological events in CLOSURE I may draw into question that study’s accuracy in correctly measuring outcomes and causes of secondary events.”
The Gore REDUCE Clinical Study is a prospective, randomised, multicentre, multinational trial designed to demonstrate safety and effectiveness of the Gore Helex Septal Occluder for PFO closure in patients with history of cryptogenic stroke or imaging-confirmed transient ischaemic attack. The unique study, which includes up to 50 investigational sites in the USA and Europe, is on track to meet its estimated completion in 2014.
