Evaluation of the Endeavor Resolute Zotarolimus-Eluting Coronary Stent System in a Real-World Patient Population in China (R-C Registry)

• Target lesion failure (TLF) [ Time Frame: 12m ] [ Designated as safety issue: Yes ]
  Target lesion failure (TLF): 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 at 1 year.
  
  

• Overall stent thrombosis [ Time Frame: 12m ] [ Designated as safety issue: Yes ]
  Overall stent thrombosis, defined as definite and probable stent thrombosis, according to the Academic Research Consortium (ARC) definition, at 1 year.
  
  
• Device success, Lesion success, Procedural success [ Time Frame: At the end of the index procedure or during hospital stay ] [ Designated as safety issue: Yes ]
  
• TLF [ Time Frame: 30 days, 6 months, 2 year, 3 year, 4 year and 5 year ] [ Designated as safety issue: Yes ]
  Target lesion failure (TLF): 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 will be assessed at 30 days, 6 months, 2 year, 3 year, 4 year and 5 year
  
  
• All deaths (cardiac, vascular and non-cardiovascular) [ Time Frame: 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year ] [ Designated as safety issue: Yes ]
  
• Stent thrombosis rate [ Time Frame: at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year ] [ Designated as safety issue: Yes ]
  defined as definite, probable, possible, and overall stent thrombosis (according to ARC definition)
  
  
• Myocardial infarction [ Time Frame: at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year ] [ Designated as safety issue: Yes ]
  Q wave and non-Q wave MI
  
  
• Revascularization [ Time Frame: at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year ] [ Designated as safety issue: No ]
  target lesion and target vessel revascularization (TLR and TVR)
  
  
• Significant bleeding complications and stroke [ Time Frame: at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year ] [ Designated as safety issue: Yes ]
  hemorrhagic in nature
  
  
• Target vessel failure (TVF) [ Time Frame: at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year ] [ Designated as safety issue: Yes ]
  a composite endpoint of cardiac death, target vessel myocardial infarction, or clinically-driven target vessel revascularization
  
  
• Major adverse cardiac events (MACE) [ Time Frame: at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year ] [ Designated as safety issue: Yes ]
  a composite endpoint of death, myocardial infarction (Q wave and non-Q wave), emergent coronary bypass surgery, or repeat target lesion revascularization (clinically driven/clinically indicated) by percutaneous or surgical methods
  
  

The Resolute stent is designed to support the approach of delivering drug to the coronary arterial tissue over a longer period of time than that offered by current approved DES products. This method of prolonged drug elution may address the need to control local vascular neointimal proliferation in patients with complex lesions for extended therapeutic effect. The purpose of this multi-center trial is to investigate the clinical safety and efficacy of the Endeavor Resolute drug-eluting stent in every-day patients, like stable and unstable patients with single or multi-vessel disease and/or complex lesions.

Patients should be treated according to normal hospital routine practice and in line with the applicable guidelines on percutaneous coronary interventions and the Instructions For Use of the device.

1800 patients will be enrolled from China at approximately 40 centers where Endeavor Resolute stent is commercially available.