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

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 defined as achievement of a final diameter stenosis of <50% (by visual estimate), using the assigned device only

Lesion success defined as the attainment of <50% final diameter stenosis (by visual estimate) using any percutaneous method.

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

Target Lesion Revascularization (TLR) is defined as any clinically-driven repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel

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 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:

• MI occurs in territory not clearly attributed to a vessel other than the target vessel.
• Cardiac death not clearly due to a non-target vessel endpoint.
• Target vessel revascularization is performed.

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

• 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
• Pathological findings of an acute myocardial infarction

Thrombosis is defined as the formation of blood clot derived from aggregation of red cells or platelets obstructing the lumen of the vessel.

Target Lesion Revascularization (TLR) is defined as any clinically-driven repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel

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 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:

• MI occurs in territory not clearly attributed to a vessel other than the target vessel.
• Cardiac death not clearly due to a non-target vessel endpoint.
• Target vessel revascularization is performed.

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

• 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
• Pathological findings of an acute myocardial infarction

Thrombosis is defined as the formation of blood clot derived from aggregation of red cells or platelets obstructing the lumen of the vessel.