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 sutdy is composed of two parts: A Randomized Controlled Trial, outlined in a separate posting and the registry portion of this study, which is as follows: -A prospective controlled registry to analyze the clinical efficacy and safety at mid and long-term follow-up in patients with MVD treated with the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS).
Study Type
OBSERVATIONAL
Enrollment
400
Coronary artery placement of a drug-eluting stent (XIENCE V® EECSS)
A.O. San Giovanni di Dio
Agrigento, Italy
Ospedale Maggiore Bologna
Bologna, Italy
Composite endpoint of all Death, MI (Q-wave and non Q-wave), and ischemia-driven Target Vessel Revascularization (TVR) .
Composite endpoints are endpoints made up of a range of statistical parameters.
Time frame: 12 months
Adjudicated stent thrombosis
Time frame: 30 days
Revascularizations (TLR/TVR/any revascularization)
Time frame: 30 days
Composite endpoint of cardiac death, MI (Q-wave and non Q-wave), and ischemia-driven TLR.
Time frame: 30 days
Composite endpoint of all death, MI (Q-wave and non Q-wave), and TVR.
Time frame: 30 days
Device success
Achievement of a final residual in-stent diameter stenosis of \< 30% (visual assessment) using the assigned device only.
Time frame: At time of index procedure
Lesion success
Attainment of \< 30% residual in-stent stenosis (by visual assessment) using any percutaneous method.
Time frame: At time of index procedure
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 time of index procedure
Adjudicated stent thrombosis
Time frame: 1 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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 13 more locations
Adjudicated stent thrombosis
Time frame: 2 years
Adjudicated stent thrombosis
Time frame: at 3 years
Revascularizations (TLR/TVR/any revascularization)
Time frame: 1 year
Revascularizations (TLR/TVR/any revascularization)
Time frame: 2 years
Revascularizations (TLR/TVR/any revascularization)
Time frame: 3 years
Composite endpoint of cardiac death, MI (Q-wave and non Q-wave), and ischemia-driven TLR.
Time frame: 1 years
Composite endpoint of cardiac death, MI (Q-wave and non Q-wave), and ischemia-driven TLR.
Time frame: 2 years
Composite endpoint of cardiac death, MI (Q-wave and non Q-wave), and ischemia-driven TLR.
Time frame: 3 years
Composite endpoint of all death, MI (Q-wave and non Q-wave), and TVR.
Time frame: 2 years
Composite endpoint of all death, MI (Q-wave and non Q-wave), and TVR.
Time frame: 3 years