Coronary Artery Disease Clinical Trial
Official title:
A Clinical Evaluation of the XIENCE Everolimus Eluting Coronary Stent System in the Treatment of Women With de Novo Coronary Artery Lesions
The purpose of this Clinical Evaluation is the continued assessment of the XIENCE Everolimus Eluting Coronary Stent System (XIENCE V® and XIENCE PRIME™ EECSS) with the primary focus on clinical outcomes in the treatment of female patients with de novo coronary artery lesions, and the characterization of the female population undergoing stent implantation with a XIENCE stent.
SPIRIT Women Single-Arm Study: A prospective, open label, single arm, multi-center study
evaluating performance of the XIENCE V® and XIENCE PRIME™ EECSS in the treatment of female
patients with coronary artery lesions, per its Instructions for Use (IFU).
The long term safety and efficacy of the XIENCE V EECSS have been demonstrated in the SPIRIT
FIRST trial up to 5 years, the SPIRIT II trial up to 4 years, and in the SPIRIT III
Randomized Control Trial (RCT) up to 3 years. In addition, these pre-approval studies have
shown low rates of Target Vessel Failure and Major Adverse Cardiac Events (MACE) that were
observed to plateau or gradually decline after about 1 year and were consistently lower than
the comparator arm of each study. This benefit in MACE is sustained for up to 5 years and is
also independent of the first year results.
The post approval SPIRIT V study demonstrated that the use of the XIENCE EECSS in complex
lesions in a real-world population resulted in 1 year MACE, Stent Thrombosis and Target
Lesion Revascularization rates that are comparable to those of the previously mentioned
pre-approval studies which included patients with more restricted inclusion / exclusion
criteria.
Therefore, based on existing data from these trials, Abbott Vascular has decided to
discontinue further follow up in the SPIRIT Women study after 2 years.
;
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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