Abbott has begun the Xience V USA post-approval study, with six U.S. hospital centers already recruiting and enrolling patients, one week after the FDA approved Xience V everolimus-eluting coronary stent system.
The Xience V USA study will evaluate the safety and effectiveness of the drug eluting stent (DES) in a real-world clinical setting for five-year follow up, according to the Abbott Park, Ill.-based company.
Jack Jones, MD, interventional cardiologist and medical director of the Stormont-Vail Catheterization Lab in Topeka, Kan., was one of the first physicians to enroll a patient in the study.
The Xience V USA study is designed to evaluate at least 5,000 coronary artery disease patients treated with the Xience V DES at approximately 250 centers across the U.S.
The company said its primary endpoints are a measure of stent thrombosis every year out to five years, as defined by the Dublin/Academic Research Consortium (ARC), and the composite rate of cardiac death and any heart attack (Q-wave or non-Q-wave MI) in patients at one year. The secondary endpoints include patient compliance with prescribed anti-platelet medication, measures of re-treatment by stenting or surgery and device and procedural success.