NCT00531011

EXecutive RCT: Evaluating XIENCE V® in a Multi Vessel Disease

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.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Coronary Disease
• Coronary Artery Disease
• Coronary Artery Stenosis
• Coronary Artery Restenosis

Interventions

Type	Name	Description
DEVICE	XIENCE V® Everolimus Eluting Coronary Stent System	Coronary artery placement of a drug-eluting stent
DEVICE	TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System	Coronary artery placement of a drug-eluting stent

Timeline

• Start date: 2007-09-01
• Primary completion: 2010-03-01
• Completion: 2011-06-01
• First posted: 2007-09-18
• Last updated: 2015-06-08
• Results posted: 2011-08-15

Locations

24 sites across 1 country: Italy