Sprinter Legend Balloon Catheter

Inclusion Criteria:

• Patient is greater than18 years of age and able to give informed consent.

• Patient with stenotic lesions in coronary arteries or bypass graft stenosis that aresuitable for percutaneous coronary intervention (PCI).

• The patient has single or multiple vessel coronary artery disease and clinicalevidence of ischemic heart disease, stable or unstable angina, silent ischemia, and/ora positive functional study.

• Female patients of childbearing potential must have a negative pregnancy test withinseven (7) days before the procedure.

• Patient or patient's legal representative has been informed of the nature of the trialand agrees to its provisions and has provided written informed consent as approved bythe Institutional Review Board (IRB) of the respective investigational site.

• Patients with symptomatic ischemic heart disease due to stenotic lesions in coronaryarteries or bypass graft stenosis that are amenable to percutaneous treatment.

Exclusion Criteria:

• A known hypersensitivity or contraindication to aspirin, heparin, or bivalirudin,anti-platelet medications, or sensitivity to contrast media, which cannot beadequately pre-medicated.

• A serum creatinine level > 2.0 mg/dl within seven days prior to index procedure.

• Evidence of an acute myocardial infarction within 72 hours of the intended indexprocedure (defined as: Q wave myocardial infarction or non-Q wave myocardialinfarction having creatine kinase myocardial-band isoenzyme (CK-MB) or troponinelevated above the Institution's upper limit of normal).

• During the index procedure, the target lesion requires additional treatment with acutting balloon, any artherectomy, any laser, thrombectomy, etc.

• History of stroke or transient ischemic attack (TIA) within the prior 6 months.

• Active peptic ulcer or upper gastrointestinal (GI) bleeding within the prior 6 months.

• History of bleeding diathesis or coagulopathy or will refuse blood transfusions.