Study of Near Infrared Spectroscopy (NIRS) and Intravascular Ultrasound (IVUS) Combination Coronary Catheter

Inclusion criteria

• >=18yrs of age.
• diagnosed with stable angina pectoris or documented silent ischemia
• scheduled for elective, non-emergent cardiac catheterization
• able to read, understand, and provide written informed consent
• >=1 obstructive stenosis (>50%DS by visual estimate)in a major native coronary artery
• clinically indicated treatment plan includes placement of a guidewire into the target artery.
• target artery has a >=30mm segment with a reference vessel diameter >=2.5mm
• target artery has a >50%DS luminal narrowing

Exclusion criteria

• Subject unwilling or unable to provide written informed consent.
• Subject unwilling to comply with protocol
• Subject is pregnant
• Subject is of childbearing potential without negative pregnancy test.
• Subject received prolonged CPR within 2 weeks of enrollment procedure
• Subject is intubated.
• Subject is diagnosed with an acute coronary syndrome.
• Subject has severe persistent hypertension.
• Subject has renal dysfunction or insufficiency.
• Subject has an abnormal platelet count.
• Subject has low hemoglobin levels.
• Subject has active liver disease or dysfunction.
• subject diagnosed with acute pulmonary edema or congestive heart failure.
• Subject diagnosed or suspected to have acute myo-, peri-, or endo- carditis, cardiac tamponade, or dissected aortic aneurysm.
• Subject has significant valvular heart disease, cardiomyopathy, or congenital heart disease.
• Subject has history of intracranial bleeding or aneurysm.
• Subject has a history of stroke that precludes the use of routine antithrombotic agents during PCI?
• Subject has known hypercoagulable state, coagulopathy, or abnormal bleeding.
• subject has family history of coagulopathy or bleeding diathesis.
• subject has undergone PCI in the last 30days.
• subject enrolled or participating in pharmaceutical study in last 30 days.
• subject enrolled or participating in medical device treatment study in last 30 days.
• subject has obstructive LMCA disease.
• subject has multivessel CAD that requires additional treatment in a separate procedure with 30days of enrollment.
• subject has unprotected left main disease.
• three vessel intervention is required during enrollment procedure.
• target artery is the left circumflex artery.
• target artery is accessed through a vein or arterial graft.
• target artery is tortuous
• target artery contains segments of severe calcification
• target artery has >2 serial obstructions exceeding 50%DS.
• target artery has an aneurysm or suspected aneurysm.
• target artery has <=1 TIMI flow.
• target lesion is >99% DS.
• target lesion is severely calcified
• target lesion has angiographic characteristics of thrombus.
• target lesion has angiographic characteristics of ulceration.
• target lesion has inclusion of a side branch greater than 1mm.
• target lesion is located in a vessel segment with >4.0mm reference vessel diameter.