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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Coronary artery placement of a drug-eluting stent
Coronary artery placement of a drug-eluting stent
A.O. San Giovanni di Dio
Agrigento, Italy
Ospedale Maggiore Bologna
In-stent Late Loss (LL)
Full Analysis Set (FAS). LL is defined as the difference between the post-procedure (immediately post placement of the stent) minimal lumen diameter (MLD) and the follow-up MLD (at 270 days). In stent is measured within the confines of the stent edges.
Time frame: at 270 days
In-stent Binary Restenosis Rate
This measures the percentage of patients who have \> 50% diameter stenosis of the assessed vessel, within the stent edges.
Time frame: at 9 months
In-segment Binary Restenosis Rate
This measures the percentage of patients who have \> 50% diameter stenosis of the assessed vessel, within the stent edges In-segment is measured within the confines of the stent edges plus within 5 mm on either side of the stent.
Time frame: at 9 months
In-segment Late Loss (LL)
LL is defined as the difference between the post-procedure (immediately post placement of the stent) minimal lumen diameter (MLD) and the follow-up MLD (at 270 days). In segment LL is measured within the confines of the stent edges and within 5 mm of those edges.
Time frame: at 9 months
Composite Rate of Cardiac Death, Myocardial Infarction (MI, Both Q-wave and Non Q-wave), and Ischemia-driven Target Lesion Revascularization (TLR) .
This measure is a calculation of the percentage of participants who experience any of the components of this composite measure.
Time frame: at 30 days
Composite Rate of All Death, MI (Q-wave and Non Q-wave), and Target Vessel Revascularization (TVR).
Time frame: at 30 days
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Bologna, Italy
Policlinico S. Orsola - Malpighi
Bologna, Italy
A.O. Cannizzaro
Catania, Italy
A.O. Universitaria Vittorio Emanuele - Ferrarotto - S. Bambino
Catania, Italy
A.O. Università Mater Domini c/o Campus Università Magna Grecia
Catanzaro, Italy
A.O. Universitaria OO.RR Foggia
Foggia, Italy
E.O. Ospedali Galliera
Genova, Italy
A.O. Carlo Poma
Mantova, Italy
Centro Cardiologico Monzino
Milan, Italy
...and 14 more locations
Lesion Success
defined as attainment of \< 30% residual in-stent stenosis (by visual assessment) using any percutaneous method.
Time frame: at the time of PCI
Procedural Success
defined as: residual in-stent %DS of \< 30% using a percutaneous method, without cardiac death, Q-wave MI, non Q-wave MI, or repeat revasc of the target during hospitalization.
Time frame: at the time of PCI
Device Success
defined as achievement of a final residual in-stent diameter stenosis of \< 30% (visual assessment) using the assigned device only.
Time frame: at the time of PCI
Adjudicated Stent Thrombosis.
Time frame: at 30 days
Adjudicated Stent Thrombosis.
Time frame: 9 months
Revascularizations
(TLR/TVR/any revascularization)both ischemia-driven and not ischemia-driven.
Time frame: at 30 days
Revascularizations
(TLR/TVR/any revascularization)both ischemia-driven and not ischemia-driven.
Time frame: 9 months
Composite Endpoint of Cardiac Death, MI (Q-wave and Non Q-wave), and Ischemia-driven TLR .
ITT
Time frame: 9 months
Composite Endpoint of All Death, MI (Q-wave and Non Q-wave), and TVR.
Time frame: 9 months
In-stent Minimum Lumen Diameter (MLD).
Time frame: at 9 months.
In-segment Minimum Lumen Diameter (MLD).
Time frame: at 9 months.
Proximal Minimum Lumen Diameter (MLD).
Proximal refers to the immediate 5 mm outside of the proximal end of the stent.
Time frame: at 9 months.
Distal Minimum Lumen Diameter (MLD).
Distal refers to the immediate 5 mm outside of the distal end of the stent.
Time frame: at 9 months.