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Abbott starts Xience V USA post-approval study at six hospital centres

Abbott Vascular : 10 July, 2008  (Company News)
Abbott has started the Xience V USA post-approval study, with six hospital centres already recruiting and enrolling patients just one week after the US Food and Drug Administration approved the Xience V Everolimus Eluting Coronary Stent System.
The Xience V USA study will evaluate the safety and effectiveness of the Xience V drug eluting Stent in a real-world clinical setting out to five years. Jack Jones, MD, interventional cardiologist and medical director of the Stormont-Vail Catheterization Lab in Topeka, Kansas, USA, was one of the first physicians to enroll a patient into the study.

'Xience V is an important innovation that gives patients in the United States access to a next-generation drug eluting Stent that has been shown in clinical trials to improve patient outcomes,' said Dr Jones. 'During the Stent procedure, we found it easy to deliver Xience V to the diseased portion of the vessel. With its combination of clinical efficacy and deliverability, I believe that Xience V will become a key advancement in the treatment of coronary artery disease.'

The Xience V USA study is designed to evaluate at least 5,000 coronary artery disease patients treated with the Xience V drug eluting Stent at approximately 250 centres across the USA. The primary endpoint of Xience V USA is a measure of Stent thrombosis (formation of blood clots) every year out to five years, as defined by the Dublin/Academic Research Consortium (ARC). The ARC definition of late Stent thrombosis was developed to eliminate variability in the definitions across various drug eluting Stent trials.

The co-primary endpoint of the study is the composite rate of cardiac death and any heart attack (Q-wave or non-Q-wave myocardial infarction) in patients at one year. Secondary endpoints of the study include patient compliance with prescribed anti-platelet medication, measures of re-treatment by stenting or surgery, and device and procedural success.

'Post-approval studies allow physicians to follow the safety and efficacy of new treatments in a more complex patient population than is typically studied in pre-approval clinical trials. Xience V USA will provide significant insight about the performance of Abbott's new drug eluting Stent in a variety of patients,' said Charles Simonton, MD, FACC, FSCAI, divisional vice president, Medical Affairs and chief medical officer, Abbott Vascular. 'Our ability to work with our physician partners to begin this post-approval study within days of FDA approval is further evidence of Abbott's commitment to help the interventional cardiology community gain additional insights about the clinical benefits of Xience V.'
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