Healthcare product and device developer Abbott’s vascular business unit has inaugurated its Xience V Spirit Women clinical trial, designed to study the safety and effectiveness of drug eluting stent treatment in women. The goal of the trial is to increase understanding of how heart disease affects women and to assess the performance of Abbott’s Xience V everolimus eluting coronary stent system in women with previously untreated coronary artery lesions from Europe, Asia-Pacific, Canada and Latin America, according to the Abbott Park, Ill.-based firm.
The company said that the trial will focus on specific aspects of women's health in relation to coronary artery disease such as general awareness about the disease, symptoms at time of presentation, referral patterns and hormonal menopausal status.
Xience V Spirit Women will include approximately 2,000 women from about 100 sites throughout Europe, Asia-Pacific, Canada and Latin America. The trial will evaluate patient and disease characteristics specific to women such as menopausal status and hormonal profiles, as well as treatment outcomes including death, heart attack, the need for re-treatment (target vessel revascularization) and potential risk of stent thrombosis.
Dr. Liliana Grinfeld, of the Hospital Italiano in Buenos Aires, Argentina, performed the first procedure, Abbott said.