Coronary Artery Disease Clinical Trial
Official title:
SPIRIT V: A Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Coronary Artery Lesions
The purpose of this Clinical Evaluation is a continuation in the assessment of the performance of the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS) in the treatment of patients with de novo coronary artery lesions in patients (Diabetic sub-study).
The SPIRIT V Clinical Evaluation consists of two concurrent studies,the Diabetic sub-study
and the Registry.
The SPIRIT V Diabetic sub-study is a prospective, randomized, active-controlled, single
blind, parallel two-arm multi-center study comparing the XIENCE V® EECSS to the TAXUS®
Liberté™ in the treatment of diabetic patients with coronary artery lesions who will fulfill
the eligibility criteria. Approximately 300 patients will be randomized (2:1) against the
TAXUS® Liberté™ coronary stent system. These patients will be recruited in up to 40 selected
sites.
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 V Diabetic study after 1 year.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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