NG PROMUS Stent System for the Treatment of Atherosclerotic Coronary Lesions

Technical success is defined as successful delivery and deployment of the study stent to the target lesion, without balloon rupture or stent embolization, and post-procedure diameter stenosis of <30% assessed in 2 near-orthogonal projections with TIMI 3 flow in the target lesion, as visually assessed by the physician

Target lesion revascularization is any ischemia-driven repeat percutaneous intervention, to improve blood flow, of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion. A TLR will be considered as ischemia-driven if the target lesion diameter stenosis is >/= 50% by QCA and there is presence of clinical or functional ischemia which cannot be explained by other coronary or graft lesions. Clinical or functional ischemia is any of the following:

• The subject has a positive functional study corresponding to the area served by the target lesion.
• The subject has ischemic ECG changes at rest in a distribution consistent with the target vessel.
• The subject has ischemic symptoms referable to the target lesion. A TLR will be considered as ischemia-driven if the lesion diameter stenosis is >/= 70% by QCA even in the absence of clinical or functional ischemia.

Target lesion failure is any ischemia-driven revascularization of the target lesion, MI (Q-wave and non-Q-wave) related to the target vessel, or (cardiac) death. For the purposes of this protocol, if it cannot be determined with certainty whether the MI was related to the target vessel, it will be considered a TLF.

The MI definition used for Target Lesion Failure was the PLATINUM MI definition.

Target vessel revascularization is defined as a TLR or a TVR remote. Target vessel revascularization remote is any ischemia-driven repeat percutaneous intervention, to improve blood flow, or bypass surgery of not previously existing lesions diameter stenosis >/= 50% by QCA in the target vessel, excluding the target lesion. A TVR will be considered ischemia-driven if the target vessel diameter stenosis is >/= 50% by QCA and any of the following are present:

• The subject has a positive functional study corresponding to the area served by the target vessel.
• The subject has ischemic ECG changes at rest in a distribution consistent with the target vessel.
• The subject has ischemic symptoms referable to the target vessel. A TVR will also be considered as ischemia-driven if the lesion diameter stenosis is >/=70% even in the absence of clinical or functional ischemia.

Target vessel failure is any ischemia-driven revascularization of the target vessel, MI (Q-wave and non-Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF.

The MI definition used was the PLATINUM MI definition.

MI will be defined according to the PLATINUM Definition of MI with evidence pre-specified for i) Spontaneous, ii) PCI-related, iii) CABG related, and iv) autopsy evidence criteria.

Cardiac death is defined as death due to any of the following.

• Acute MI
• Cardiac perforation/pericardial tamponade
• Arrhythmia or conduction abnormality
• CVA through hospital discharge or CVA suspected of being related to the procedure
• Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery
• Any death in which a cardiac cause cannot be excluded

Non-cardiac death is defined as a death not due to any of the following:

• Acute MI
• Cardiac perforation/pericardial tamponade
• Arrhythmia or conduction abnormality
• CVA through hospital discharge or CVA suspected of being related to the procedure
• Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery
• Any death in which a cardiac cause cannot be excluded

Death is categorized as cardiac or non-cardiac deaths.

Any cardiac death or MI event meeting the criteria defined for a cardiac death or MI.

MI definition used was the PLATINUM definition for MI.

Any all-cause mortality event or MI meeting the criteria defined for any death or MI.

MI definition used was the PLATINUM definition for MI.

Any event meeting the pre-specified criteria for any death, MI, or TVR.

MI definition used was the PLATINUM definition for MI.

Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guide catheter has been removed and the patient left the catheterization lab.

Timing:

• Acute stent thrombosis*: 0 24 hours after stent implantation
• Subacute stent thrombosis*: >24 hours to 30 days after stent implantation
• Late stent thrombosis: >30 days to 1 year after stent implantation
• Very late stent thrombosis: >1 year after stent implantation * Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis is 0 30 days.

Stent thrombosis may be defined as:

• Confirmed/definite
• Probable
• Possible

Confirmed/Definite (is considered either angiographic confirmed or pathologic confirmed)

Clinical procedural success is post-procedure diameter stenosis <30% in 2 near-orthogonal projections with TIMI 3 flow in all target lesions, as visually assessed by the physician, without the occurrence of in-hospital MI, TVR, or cardiac death.

MI definition used was the PLATINUM definition for MI.

As measured by an independent angiographic core laboratory using quantitative coronary angiography (QCA), the % diameter stenosis of the in-stent region.

Percent diameter stenosis: Relative changes that occur in the percent diameter stenosis are provided by the following relationship: % diameter stenosis= (1-[Minimum Lumen Diameter/Reference diameter]) x 100.

As measured by an independent angiographic core laboratory using quantitative coronary angiography (QCA), the % diameter stenosis of the in-segment region (in-segment includes the stented region and 5 mm edge regions).

Percent diameter stenosis: Relative changes that occur in the percent diameter stenosis are provided by the following relationship: % diameter stenosis= (1-[Minimum Lumen Diameter/Reference diameter]) x 100.

As measured by an independent angiographic core laboratory using quantitative coronary angiography (QCA); the minimum lumen diameter (MLD) measured at the in-stent region.

The MLD is the mean minimum lumen diameter (mm) from 2 orthogonal views.

As measured by an independent angiographic core laboratory using quantitative coronary angiography (QCA); the minimum lumen diameter (MLD) measured at the in-segment region (in-segment includes the stented region and 5 mm edge regions).

The MLD is the mean minimum lumen diameter (mm) from 2 orthogonal views.

Acute gain, as measured by angiographic core lab

As measured by IVUS, the mean vessel area (mm2).

As measured by IVUS, the area of the stent.

As measured by IVUS, the area of the lumen.

As measured by IVUS, the volume of the vessel.

As measured by IVUS, the volume of the stent.

As measured by IVUS, the volume of the lumen.

Incomplete apposition rate, as measured by the IVUS core lab.

Binary assessment of presence of one or more stent struts separated from the vessel wall as detected through intravascular ultrasound (IVUS).

The percentage of volume obstruction, as measured by the IVUS core lab.

Longitudinal stent deformation, evidenced by longitudinal compression or elongation, as the result of crossing a newly deployed stent with a second device, (such as a balloon catheter, stent system or IVUS catheter), causing the second device to become caught on the stent when the second device is advanced or retracted.