Resolute Zotarolimus-Eluting Stent Versus the Taxus Liberte Paclitaxel-Eluting Stent for Percutaneous Coronary Intervention in China (R-China RCT)

• in-stent late lumen loss (LLL) [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  in-stent late lumen loss (LLL), defined as the difference between the post-procedure minimal lumen diameter (MLD) and the follow-up angiography MLD.
  
  

• Device success [ Time Frame: at the end of the index procedure or during hospital stay ] [ Designated as safety issue: No ]

  Definition 1: The attainment of <50% residual stenosis of the target lesion using only the assigned device.

  Definition 2: The attainment of < 30% residual stenosis by QCA (or < 20% by visual assessment) AND a TIMI flow 3 after the procedure, using the assigned device only. These measurements will be made by the independent angiographic core laboratory. If the core laboratory is unable to assess the % residual stenosis, the Investigator's assessment as recorded in the CRF will be used for the statistical analysis.

  
  
• Death [ Time Frame: 30d, 6m, 12m, 2yr, 3yr, 4yr, 5yr ] [ Designated as safety issue: Yes ]
  All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.
  
  
• Myocardial infarction [ Time Frame: 30d, 6m, 12m, 2yr, 3yr, 4yr, 5yr ] [ Designated as safety issue: Yes ]
  All myocardial infarction data will be reported per Medtronic historical protocol definitions and according the Academic Research Consortium (ARC) definitions.
  
  
• MACE composite endpoint [ Time Frame: 30d, 6m, 12m, 2yr, 3yr, 4yr, 5yr ] [ Designated as safety issue: Yes ]
  Death, myocardial infarction (MI) (Q wave and non-Q wave), emergent coronary bypass surgery (CABG), or clinically-driven repeat target lesion revascularization by percutaneous or surgical methods.
  
  
• Composite endpoint of (all cause) mortality, Myocardial Infarction (Q-wave and non Q-wave) or (any) revascularization [ Time Frame: 30d, 6m, 12m, 2yr, 3yr, 4yr, 5yr ] [ Designated as safety issue: Yes ]
  Mortality, Myocardial Infarction (Q-wave and non Q wave) or (any) revascularization.
  
  
• All revascularizations [ Time Frame: 30d, 6m, 12m, 2yr, 3yr, 4yr, 5yr ] [ Designated as safety issue: Yes ]
  Target Legion Revascularization (TLR), Target Vessel Revascularization (TVR) and Non-TVR.
  
  
• Target lesion failure (TLF) [ Time Frame: 30d, 6m, 12m, 2yr, 3yr, 4yr, 5yr ] [ Designated as safety issue: No ]
  A composite endpoint of cardiac death, target vessel myocardial infarction (Q wave and non Q wave) or clinically-driven target lesion revascularization (TLR) by percutaneous or surgical methods.
  
  
• Target vessel failure (TVF) [ Time Frame: 30d, 6m, 12m, 2yr, 3yr, 4yr, 5yr ] [ Designated as safety issue: No ]
  A composite endpoint of cardiac death, target vessel myocardial infarction, or clinically-driven target vessel revascularization(TVR.
  
  
• Stent thrombosis [ Time Frame: 30d, 6m, 12m, 2yr, 3yr, 4yr, 5yr ] [ Designated as safety issue: Yes ]
  As determined by Medtronic historic and ARC definitions.
  
  
• Lesion success [ Time Frame: At the end of the index procedure or during hospital stay ] [ Designated as safety issue: No ]

  Definition 1: The attainment of <50% residual stenosis of the target lesion using any percutaneous method.

  Definition 2: The attainment of < 30% residual stenosis by QCA (or < 20% by visual assessment) AND a TIMI flow 3 after the procedure, using any percutaneous method. These measurements will be made by the independent angiographic core laboratory. If the core laboratory is unable to assess the % residual stenosis, the Investigator's assessment as recorded in the CRF will be used for the statistical analysis.

  
  
• Procedure success [ Time Frame: At the end of the index procedure or during hospital stay ] [ Designated as safety issue: No ]

  Definition 1: The attainment of <50% residual stenosis of the target lesion and no in-hospital MACE.

  Definition 2: The attainment of < 30% residual stenosis by QCA (or < 20% by visual assessment) AND a TIMI flow 3 after the procedure, using any percutaneous method without the occurrence of MACE during the hospital stay. These measurements will be made by the independent angiographic core laboratory. If the core laboratory is unable to assess the % residual stenosis, the Investigator's assessment as recorded in the CRF will be used for the statistical analysis.

  
  

This study is a prospective, multicenter, randomized, two-arm, open-label study, designed to assess the non-inferiority of Resolute stent compared to Taxus Liberte stent in in-stent late lumen loss.

The primary objective of this study is to evaluate the in-stent late lumen loss (LLL) at 9 months, defined as the difference between the post-procedure minimal lumen diameter (MLD) and the follow-up angiography MLD, of the Resolute Zotarolimus-Eluting Coronary Stent System compared to Taxus Liberte Paclitaxel-Eluting Coronary Stent System in a real-world all-comer patient population requiring stent implantation.

This trial will be conducted at approximately 20 sites and will enroll up to 400 subjects, randomized to the Resolute stent and Taxus Liberte stent in a 1:1 ratio. Subjects will be randomized using an interactive voice response system (IVRS).

Due to the design characteristics of the devices, the study investigators and operators can not be blinded. However, the clinical event adjudication committee, consisting of cardiologists who are not participating in the study, will be blinded for the treatment arm of the subjects to avoid a potential bias in the adjudication process of events.