Abbott Expands XIENCE V USA Trial To Enroll 3,000 Patients
To evaluate the safety and effectiveness of the Coronary Stent System
Abbott has expanded XIENCE V USA post-approval study, designed to evaluate the safety and effectiveness of the company's XIENCE V Everolimus Eluting Coronary Stent System in a real-world clinical setting out to five years.
Charles Simonton, divisional vice president of medical affairs and chief medical officer at Abbott Vascular, said: The expansion of the XIENCE V USA trial will enable Abbott to enroll more than 2,000 patients who may be eligible to also participate in the DAPT Trial to help advance the body of scientific knowledge regarding the best duration for patients to take blood-thinning medications after a stent procedure. We anticipate the DAPT Trial results will be instrumental in establishing definitive guidelines. As an industry leader, Abbott is proud to play a significant role in contributing patients to this important study.
The XIENCE V USA trial expansion allows for an additional 3,000 patients to be enrolled into Abbott's study, which was originally designed to study 5,000 patients in the US. The primary endpoint of XIENCE V USA is a measure of stent thrombosis every year out to five years, as defined by the Dublin/Academic Research Consortium (ARC).
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