Study: NCT01268319

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Embolic Protection Device (EPD)
Description: The embolic protection device consists of a protection wire, a delivery sheath, a retrieval sheath and various accessories (wire torque device, introducer, dilator tool). The wire of the EPD is used as a standard 0.014 steerable guide wire. The filter is designed for embolic debris capture while maintaining continuous blood flow. At the completion of the procedure, the filter and its contents are removed using the retrieval sheath and then removed from the patient.

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Intracoronary Spectroscopy and Ultrasonic Evaluation
Description: This intervention requires a near infrared imaging catheter equipped with an intravascular ultrasonic transducer be used to evaluate the coronary artery wall prior to treatment and after treatment. This system detects the lipid containing plaques that may be the source of embolic debris released during standard angioplasty and stent placement.

Intervention type: DEVICE
Group type: PLACEBO_COMPARATOR
Intervention: Intracoronary Spectroscopy and Ultrasonic Evaluation
Description: This intervention requires a near infrared imaging catheter equipped with an intravascular ultrasonic transducer be used to evaluate the coronary artery wall prior to treatment and after treatment. This system detects the lipid containing plaques that may be the source of embolic debris released during standard angioplasty and stent placement.

Intervention type: DEVICE
Group type: PLACEBO_COMPARATOR
Intervention: Intracoronary Spectroscopy and Ultrasonic Evaluation
Description: This intervention requires a near infrared imaging catheter equipped with an intravascular ultrasonic transducer be used to evaluate the coronary artery wall prior to treatment and after treatment. This system detects the lipid containing plaques that may be the source of embolic debris released during standard angioplasty and stent placement.

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Angioplasty and Stent Implant
Description: The target plaque will be treated with a pre-dilation with a standard angioplasty balloon sized to within 0.5mm of the diameter of the reference vessel diameter. The physician will then implant a coronary artery stent that is appropriately sized for the reference vessel diameter.

Intervention type: DEVICE
Group type: PLACEBO_COMPARATOR
Intervention: Angioplasty and Stent Implant
Description: The target plaque will be treated with a pre-dilation with a standard angioplasty balloon sized to within 0.5mm of the diameter of the reference vessel diameter. The physician will then implant a coronary artery stent that is appropriately sized for the reference vessel diameter.

Intervention type: DEVICE
Group type: PLACEBO_COMPARATOR
Intervention: Angioplasty and Stent Implant
Description: The target plaque will be treated with a pre-dilation with a standard angioplasty balloon sized to within 0.5mm of the diameter of the reference vessel diameter. The physician will then implant a coronary artery stent that is appropriately sized for the reference vessel diameter.