Evaluation of the Safety and Effectiveness of the CorPath 200 System in Percutaneous Coronary Interventions (PCI)

General Inclusion Criteria:

• Subject is between 18 and 99 years of age.
• Subject is an acceptable candidate for PCI.
• Subject must have clinical evidence of ischemic heart disease or a positive functional study.
• Female subjects must be of non-child bearing potential, or if able to bear children, have a negative pregnancy test within 7 days prior to the CorPath procedure.
• The subject or the legal representative has been informed of the nature of the study and agrees to its provisions and has provided written informed consent.

Angiographic Inclusion Criteria:

• Study lesion is a single de novo native coronary artery lesion. This lesion may consist of multiple lesions (with 10mm or less between diseased segments) and must be completely covered by a single stent with at least 2.0mm of normal segments on proximal and distal edges of the lesion.
• Study reference vessel diameter is between 2.5mm and 4.0mm by visual estimate.
• Study lesion length is less than or equal to 24.0mm by visual estimate.
• Study lesion diameter showing stenosis of at least 50% by visual estimate.

General Exclusion Criteria:

• Subject requires planned PCI or CABG (Coronary Artery Bypass Graft) within 30 days following the CorPath procedure.
• Evidence of an acute myocardial infarction within 72 hours prior to the intended CorPath procedure.
• Subject has documented left ventricular ejection fraction 700,000 cells/mm3, or a WBC (white blood cell) count of 2.0 mg/dL or eGFR (estimated Glomerular Filtration Rate) 90°) proximal to the target lesion.
• The study lesion has any of the following characteristics:
• Total occlusion.
• Ostial location.
• Is within 2.0 mm of a side branch measuring >2.0 mm in diameter.
• Located at < 45° bend in the vessel.
• Moderately to severely calcified.
• Moderate to severe calcification in the vessel proximal to the target lesion.
• Located in a native vessel distal to an anastomosis, with a saphenous vein graft or a left/right internal mammary artery (LIMA/RIMA) bypass, and is approached through the bypass graft.
• Unprotected left main coronary artery disease defined as an obstruction greater than 50% diameter stenosis in the left main coronary artery.