Coronary Artery Disease Clinical Trial
Official title:
EXecutive Randomized Controlled Trial (RCT): XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS) in the Treatment of the Specific Setting of Patients With Multi-vessel Coronary Artery Disease.
The purpose of this two part study is the assessment of the performance of the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS) in the treatment of the specific setting of patients with Multi-Vessel Coronary Artery Disease (MVD).
This is a clinical evaluation of the XIENCE V® everolimus eluting coronary stent system as a
revascularization treatment of patients with multi-vessel coronary artery disease (MVD-CAD).
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
consistently lower than the comparator arm of each study.
The post approval EXECUTIVE 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 EXECUTIVE trial.
The study is composed of two parts:
A Registry, outlined in a separate posting and the Randomized Control Trial (RCT) portion of
this study, which is as follows:
-A randomized group of patients aimed at assessing the angiographic efficacy of the XIENCE
V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS) compared to the TAXUS®
Liberté™ Paclitaxel Eluting Coronary Stent System.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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