Key result
SPIRIT WOMEN evaluates the XIENCE V everolimus-eluting stent in women with CAD.
Why the study?
Does the XIENCE V Everolimus-Eluting Coronary Stent System demonstrate adequate performance in female patients with coronary artery lesions?
RCT (n=2,000)
Open-label and single-blind
2:1 ratio
Yes
Does the XIENCE V Everolimus-Eluting Coronary Stent System demonstrate adequate performance in female patients with coronary artery lesions?
The XIENCE V SPIRIT WOMEN study is a large-scale prospective trial designed to evaluate the performance of everolimus-eluting stents specifically in women with coronary artery disease.
Answers are grounded in this paper and cite their sources.
Supports sex-specific stent evaluation in women; leaves open randomized comparisons by menopausal or hormonal status.
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 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.
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Marie‐Claude Morice (2008) conducted an RCT in Coronary artery disease (n=2,000). XIENCE V Everolimus-Eluting Coronary Stent System vs. CYPHER Plus stent (in substudy) was evaluated. The XIENCE V SPIRIT WOMEN study is designed to evaluate the XIENCE V Everolimus-Eluting Coronary Stent System in approximately 2000 female patients with coronary artery disease.
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