CorPath™ 200: Robotically-Assisted Percutaneous Coronary Intervention (PCI)
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Intervention: CorPath 200; CorPath 200
Intervention description: CorPath™ 200 robotically-assisted percutaneous coronary intervention; CorPath PCI - robotic-assisted percutaneous coronary intervention
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ischemia; stent

Summary:

      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.
    

Eligibility criteria:

        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).