The purpose of this study is to demonstrate non-inferiority in terms of safety and efficacy of DES Limus Carbostent compared to the Taxus Liberté in treating de-novo atherosclerotic lesions in native coronary arteries.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
323
DES Limus Carbostent Carbofilm Coated Coronary Stent
Taxus Liberté Coronary Stent
Academisch Ziekenhuis Middelheim
Antwerp, Belgium
Ziekenhuis Oost Limburg
Genk, Belgium
Clinique les Franciscaines
Nîmes, France
Institut Mutualiste Montsouris
Paris, France
angiographic efficacy measurement (mm)
in-stent Late Lumen Loss (LLL) measurement by angiography
Time frame: 180 days
QCA measurements in-stent and in-segment
Time frame: 180 days
IVUS measurements
Time frame: 180 days
Incidence of cardiac death (%)
Time frame: 30 days, 180 days, 1, 2 , 3, 4 and 5 years
Stent Thrombosis
Time frame: acute, 30 days, 180 days, 1 year, > 1 year
Acute success (Device and Procedural success)
Time frame: acute
Incidence of Myocardial Infarction (%)
Time frame: 30 days, 180 days, 1, 2, 3, 4, 5 years
Incidence of clinically indicated TLR (%)
Time frame: 30 days, 180 days, 1, 2, 3, 4, 5 years
Incidence of all deaths (%)
Time frame: 30 days, 180 days, 1, 2, 3, 4, 5 years
Incidence of all repeat revascularization (%)
Time frame: 30 days, 180 days, 1, 2, 3, 4, 5 years
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Clinique Saint-Hilaire
Rouen, France
Hôpital de Rangueil
Toulouse, France
Medizinisches Versorgungszentrum
Hamburg, Germany
Krankenhaus der Barmherzigen Brüder
Trier, Germany
Azienda Ospedaliera Careggi
Florence, Italy
Istituto di Fisiologia Clinica del CNR
Massa, Italy
...and 1 more locations