CorPath™ 200: Robotically-Assisted Percutaneous Coronary Intervention (PCI)

General Inclusion Criteria:

• The subject is an acceptable candidate for PCI.
• The 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 seven (7) days prior to index 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 de novo native coronary artery lesion (i.e., a coronary lesion not previously treated)
• The study lesion is intended to be treated with one stent. Maximum stent length allowed is 20 mm.
• The study reference vessel diameter is between 2.50 mm and 4.5 mm by visual estimate.
• Study lesion diameter showing significant stenosis of at least 50% by visual estimate.

General Exclusion Criteria:

• Subject requires planned PCI or CABG within 30 days following the index procedure.
• Subject has evolving ST elevation myocardial infarction (STEMI) (i.e., beginning of MI symptoms within 72 hours prior to the planned index procedure).
• Subject has documented left ventricular ejection fraction 700,000 cell/ mm3, a WBC of 90o) proximal to the target lesion.
• The study lesion has any of the following characteristics:
• Total occlusion
• Ostial location
• Involves a side branch > 2.0 mm vessel diameter
• Is located at >45° bend in the vessel
• Is moderately to severely calcified
• Moderate-to-severe calcification at the part of the vessel prior to target lesion
• Unprotected left main coronary artery disease (an obstruction greater than 50% diameter stenosis in the left main coronary artery).