XIENCE V SPIRIT WOMEN clinical trial: Characterization of the female population undergoing stent implantation

Abstract

The XIENCE V SPIRIT WOMEN study will focus on specific aspects of women's health in relation to coronary artery disease, such as menopausal status, use of hormonal contraceptives or their surrogates, and the referral path and symptoms at presentation. The study is a prospective, open-label, single-arm, multicenter study designed to evaluate the performance of the XIENCE V™ Everolimus-Eluting Coronary Stent System in the treatment of female patients with coronary artery lesions. It also includes a prospective, single-blind, double-arm, randomized, multicenter substudy, in which patients will be randomized in a 2:1 ratio between the XIENCE V stent and the CYPHER SELECT™ Plus. In total, approximately 2000 female patients, derived from the general interventional cardiology population, will be enrolled from up to 130 sites outside of the USA. © 2008 Future Medicine Ltd.