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 <30%.
• Subject has undergone PCI within 72 hours prior to the CorPath procedure.
• Subject has undergone PCI within 30 days prior to the CorPath procedure and experienced a major adverse coronary event (MACE) or a serious adverse event (SAE) as defined in the protocol.
• Subject has known hypersensitivity or contraindication to aspirin, heparin, ticlopidine, clopidogrel, prasugrel, stainless steel, cobalt chromium, or sensitivity to contrast media, including Visipaque™, which cannot be adequately pre-medicated or managed with clinically appropriate substitutes.
• Subject has a platelet count <100,000 cells/mm3 or >700,000 cells/mm3, or a WBC (white blood cell) count of <3,000 cells/mm3 (e.g. thrombocytopenia, thrombocythemia, neutropenia or leukopenia).
• Subject has a serum creatinine level of >2.0 mg/dL or eGFR (estimated Glomerular Filtration Rate) <30 ml/min as measured within 7 days prior to the procedure.
• Subject has suffered a stroke within 30 days prior to planned CorPath procedure.
• Subject has an active peptic ulcer or upper gastrointestinal bleeding within the 6 months prior to planned CorPath procedure.
• Subject has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions.
• Subject is currently participating in another investigational drug or drug/device or device trial and has not completed the entire follow up period.
• Femoral access is not possible.

Angiographic Exclusion Criteria:

• Target lesion that cannot be fully covered by a single stent.
• Subject requires treatment of more than one vessel.
• Any previous stent placement within 5.0 mm (proximal or distal) of the target lesion.
• The study lesion requires planned treatment with directional coronary atherectomy (DCA), laser, rotational atherectomy or any device except for balloon dilatation prior to stent placement.
• The study vessel has evidence of intraluminal thrombus.
• The study vessel has evidence of moderate to severe tortuosity (>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.