The Spirit small vessel trial is designed to study 250 patients at approximately 50 centers in the US. The primary endpoint is a composite measure of cardiac death, heart attack (target vessel myocardial infarction) and target lesion revascularization (repeat procedures on the treated vessel) at one year.
The addition of a 2.25mm size is expected to complement the broad range of Xience V lengths and diameters. Upon the FDA approval of the 2.25mm stent system, the device will be called Xience Nano in the US. The Xience V 2.25mm stent system received CE Mark approval and was launched in various countries in Europe, Asia and Latin America in March 2008.
Marco Costa, principal investigator of the Spirit small vessel trial, said: “Given the strong clinical performance and ease of use of Xience V, a smaller stent system would significantly enhance the treatment options for patients with coronary artery disease in small vessels.”