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

• < 30% final diameter stenosis of the target lesion without in-hospital major adverse cardiovascular events (MACE) (defined as the composite of death, recurrent MI, and target vessel revascularization) [ Time Frame: 48-hrs or hospital discharge, whichever occurs first ] [ Designated as safety issue: Yes ]
• Successful CorPath-assisted navigation, deployment and retrieval of the PCI devices without in-hospital MACE [ Time Frame: 48-hrs or hospital discharge whichever occurs first ] [ Designated as safety issue: Yes ]

• MACE [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
• < 30% final diameter stenosis of the target lesion without MACE [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

An open-label, prospective, single-arm study is designed to evaluate safety, clinical and technical efficacy of the CorPath 200 System in delivery and manipulation of the coronary guide wires and balloon/stent systems for use in robotically-assisted, percutaneous coronary intervention (PCI) procedures.

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 < 30%.
• Subject has known hypersensitivity or contraindication to aspirin, heparin, ticlopidine, clopidogrel, stainless steel, or a sensitivity to contrast media, which cannot be adequately pre-medicated.
• Subject has a platelet count < 100,000 cell/mm3 or > 700,000 cell/ mm3, a WBC of < 3000 cell/ mm3 (e.g. thrombocytopenia, thrombocythemia, neutropenia or leucopenia).
• Subject has a history of a stroke (CVA) or TIA within 30-days prior to planned index procedure.
• Subject has an active peptic ulcer or upper GI bleeding within the 6 months prior to planned index procedure.
• Subject has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions.
• Subject is currently participating in another investigational drug l drug or device trial that has not completed the entire follow up period.

Angiographic Exclusion Criteria:

• Study lesion that cannot be fully covered by a single stent of maximal length
• Subject requires treatment of multiple lesions in the study vessel at the time of index procedure.
• The study lesion requires planned treatment with DCA, laser, rotational atherectomy, or any device except for balloon dilatation prior to stent placement.
• The study vessel has evidence of intraluminal thrombus or moderate to severe tortuosity (> 90o) proximal to the target lesion.

• The study lesion has any of the following characteristics:

  1. Total occlusion
  2. Ostial location
  3. Involves a side branch > 2.0 mm vessel diameter
  4. Is located at >45° bend in the vessel
  5. Is moderately to severely calcified
  6. 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).