Multicenter Postmarket Surveillance Registry Evaluating Performance and Long Term Safety of the Presillion Stent

• Major Cardiac Adverse Events (Including Cardiac Death, Myocardial Infarction (Q-wave and Non Q-wave) and Clinically Driven TLR (Target Lesion Revascularization)) [ Time Frame: at 12 months follow-up ] [ Designated as safety issue: Yes ]

  Major adverse cardiac and cerebral events are defined as an adjudicated composite of cardiac death, myocardial infarction (Q-wave and non Q-wave), emergent coronary artery bypass surgery and target vessel revascularization (TVR).

  The primary safety measure was the composite of MACE up to 12 months follow up. In order to show the safety of the device, the MACE rate was compared with the performance goal for bare metal stents(experience with bare metal stents in clinical trials suggested that the 12 month MACE rate should be about 25.0%).

  
  

• Device Success [ Time Frame: Peri-procedure up to discharge ] [ Designated as safety issue: Yes ]
  Device success defined as achievement of a final diameter stenosis of <50% (by visual estimate), using the assigned device only
  
  
• Lesion Success [ Time Frame: Peri-procedure up to discharge ] [ Designated as safety issue: Yes ]
  Lesion success defined as the attainment of <50% final diameter stenosis (by visual estimate) using any percutaneous method.
  
  
• Procedural Success [ Time Frame: Peri-procedure up to discharge ] [ Designated as safety issue: Yes ]
  Procedural success defined as achievement of a final diameter stenosis of <50% (by visual estimate) using any percutaneous method, without the occurrence of death, MI (Myocardial Infarction), or repeat revascularization of the target lesion during the hospital stay
  
  
• Clinically Driven TLR [ Time Frame: Up to 30 days ] [ Designated as safety issue: Yes ]
  Target Lesion Revascularization (TLR) is defined as any clinically-driven repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel
  
  
• Clinically Driven TVR [ Time Frame: Up to 30 days ] [ Designated as safety issue: Yes ]
  Target vessel revascularization (TVR) is defined as any clinically driven (as defined for TLR) repeat percutaneous intervention of the target vessel or bypass surgery of the target vessel.
  
  
• Target Vessel Failure [ Time Frame: Up to 30 days ] [ Designated as safety issue: Yes ]

  Target vessel failure includes any target vessel revascularization as well as any MI or any cardiac death that cannot be clearly attributed to a non-target vessel.

  Target vessel failure will be reported when:

  1. MI occurs in territory not clearly attributed to a vessel other than the target vessel.
  2. Cardiac death not clearly due to a non-target vessel endpoint.
  3. Target vessel revascularization is performed.
  
  
• Myocardial Infarction [ Time Frame: Up to 30 days ] [ Designated as safety issue: Yes ]

  A positive diagnosis of myocardial infarction is made when one of the following criteria is met:

  1. Typical rise and/or fall of biochemical markers of myocardial necrosis together with evidence of ischemia with at least one of the following:

     • ischemic symptoms
     • ECG changes indicative of ischemia (ST segment elevation or depression)
     • Development of pathological Q waves in the ECG
     • Imaging evidence of new an equivocal loss of viable myocardium or new regional wall motion abnormality
  2. Pathological findings of an acute myocardial infarction
  
  
• Major Bleeding [ Time Frame: Up to 30 days ] [ Designated as safety issue: Yes ]
  
• Stroke [ Time Frame: Up to 30 days ] [ Designated as safety issue: Yes ]
  
• Stent Thrombosis [ Time Frame: Up to 30 days ] [ Designated as safety issue: Yes ]
  Thrombosis is defined as the formation of blood clot derived from aggregation of red cells or platelets obstructing the lumen of the vessel.
  
  
• Clinically Driven TLR [ Time Frame: up to 12 months ] [ Designated as safety issue: Yes ]
  Target Lesion Revascularization (TLR) is defined as any clinically-driven repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel
  
  
• Clinically Driven TVR [ Time Frame: Up to 12 months ] [ Designated as safety issue: Yes ]
  Target vessel revascularization (TVR) is defined as any clinically driven (as defined for TLR) repeat percutaneous intervention of the target vessel or bypass surgery of the target vessel.
  
  
• Target Vessel Failure [ Time Frame: Up to 12 months ] [ Designated as safety issue: Yes ]

  Target vessel failure includes any target vessel revascularization as well as any MI or any cardiac death that cannot be clearly attributed to a non-target vessel.

  Target vessel failure will be reported when:

  1. MI occurs in territory not clearly attributed to a vessel other than the target vessel.
  2. Cardiac death not clearly due to a non-target vessel endpoint.
  3. Target vessel revascularization is performed.
  
  
• Myocardial Infarction [ Time Frame: Up to 12 months ] [ Designated as safety issue: Yes ]

  A positive diagnosis of myocardial infarction is made when one of the following criteria is met:

  1. Typical rise and/or fall of biochemical markers of myocardial necrosis together with evidence of ischemia with at least one of the following:

     • ischemic symptoms
     • ECG changes indicative of ischemia (ST segment elevation or depression)
     • Development of pathological Q waves in the ECG
     • Imaging evidence of new an equivocal loss of viable myocardium or new regional wall motion abnormality
  2. Pathological findings of an acute myocardial infarction
  
  
• Major Bleeding [ Time Frame: Up to 12 months ] [ Designated as safety issue: Yes ]
  
• Stent Thrombosis [ Time Frame: Up to 12 months ] [ Designated as safety issue: Yes ]
  Thrombosis is defined as the formation of blood clot derived from aggregation of red cells or platelets obstructing the lumen of the vessel.
  
  
• Stroke [ Time Frame: Up to 12 months ] [ Designated as safety issue: Yes ]
  

Primary endpoint: Composite of Major Adverse Cardiac Events (MACE), which includes cardiac death, myocardial infarction (Q-wave and non Q-wave) and clinically driven target lesion revascularization (TLR) at 12 months follow-up.

Data will be collected on 400 patients (from 14 hospitals in Spain and Portugal) treated with the Presillion stent in up to 2 de novo native coronary artery lesions

Study design: multicenter, prospective, observational