Near-Infrared Spectroscopy and Ultrasound Investigation of Coronary Artery Plaque

This is a prospective, observational, single-center registry that will enroll 100 patients.
All patients presenting to Beaumont Hospital for elective invasive coronary angiography and
possible ad hoc percutaneous coronary intervention balloon angioplasty will be considered for
inclusion. Patients must meet all inclusion and exclusion criteria prior to consent. All
information requested as part of this study will be obtained from clinical data as part of
each subject's standard medical care. Cardiac catheterization and percutaneous coronary
intervention will be performed according to standard guidelines and clinical practice. All
aspects of clinical care of the patient will follow routine standards as determined by
institutional policies, published clinical practice guidelines, and the treating physician.

After completion of routine invasive coronary angiography and upon determining that the
patient has either (1) an epicardial de novo coronary artery lesion of indeterminate severity
(>50% to <70% stenosis) that requires IVUS analysis for further delineation of stenosis
(blockage) severity; or (2) a severe epicardial de novo coronary artery lesion that requires
PCI for definitive treatment, combined NIR-IVUS imaging will be carried out in the
target-vessel. Upon completion of NIRS-IVUS imaging of the target-vessel, percutaneous
intervention will be performed in the standard fashion if deemed clinically appropriate. Upon
completion of target-vessel intervention, NIRS-IVUS imaging will then be repeated in the
target-vessel.

Upon completion of the treatment of the target-vessel, NIRS-IVUS will be performed in any
other major epicardial vessel containing a stenosis ≥30% if deemed appropriate by the
treating cardiologist.

Patients will be carefully monitored throughout their hospital stay and will be followed
either by office visit or by telephone at 6 months (± 7 days); 12 months (± 14 days); 24
months (± 30 days); 36 months (± 30 days); 48 months (± 30 days); and 60 months (± 30 days).

The patient's medical records will be accessed to collect data about medical history and
activities during the course of the study. All data will be collected by using standard case
report forms. Follow up data after discharge will be collected using a phone script
questionnaire . All data forms will include unique study identifiers to protect the
participants personal identity. All data will be recorded in an Excel spreadsheet and kept on
a secure computer requiring password entry.

There are no additional required medical procedures as part of this protocol beyond the use
of the NIRS-IVUS catheter during the index procedure.

Inclusion Criteria:

1. Subject is at least 18 years of age;

2. Subject is scheduled for elective, clinically-indicated, invasive coronary
angiography;

3. Subject is willing and able to provide informed written consent prior to invasive
angiography;

4. Combined NIRS-IVUS is not contra-indicated per the cardiologist performing invasive
coronary angiography; and

5. Patient has either: (a) An epicardial coronary artery stenosis of intermediate
severity (>50% to <70% stenosis)by invasive angiography in whom IVUS is planned to
further evaluate lesion severity; or (b) A severe epicardial coronary artery stenosis
by invasive angiography and percutaneous coronary intervention (PCI) is planned for
definitive treatment.

Exclusion Criteria:

1. Subject life expectancy at time of invasive angiography is less than 2 years;

2. Subject is pregnant or suspected to be pregnant;

3. Subject is unable to provide informed consent;

4. Any factor deemed by the treating cardiologist to put the patient at increased risk of
participating in the protocol (i.e. coronary artery anatomy is not suitable for
traditional IVUS secondary to severe tortuousity or excessive calcification).

5. Bacteremia or sepsis,

6. Major coagulation system abnormalities,

7. Severe hemodynamic instability or shock,

8. Patients diagnosed with coronary artery spasm,

9. Patients disqualified for CABG surgery,

10. Total occlusion,

11. Patients disqualified for PTCA,

12. Patients who are not suitable for IVUS procedures.