Stereotaxis Computed Tomography (CT) Co-Registration Study

Randomized Feasibility Study Comparing the Clinical Utility of the Stereotaxis Navigant™ Computed Tomography Angiography Importation and Co- Registration Feature, the NaviView™ Assisted Navigation Feature, and Standard Angiography

The Stereotaxis Niobe® II Magnetic Navigation System (MNS) is designed to direct and digitally control catheter and guidewire based therapeutic and diagnostic devices along complex trajectories within the heart and coronary vasculature.

Navigation using vectors acquired from the CT Co-registration feature of Navigant™ provides clinical benefits for percutaneous coronary intervention (PCI) by decreasing the amount of contrast used during complex PCI procedures.

Inclusion Criteria:

• Patients must be between 18-80 years of age
• Willing and able to provide prior written informed consent
• Patients present with a single bifurcated lesion or single non-CTO complex lesion requiring PCI.
• Able to be safely exposed to magnetic fields, such as magnetic resonance imaging (MRI)
• CT angiography performed prior to cardiac catheterization (must be performed >48 hours prior to procedure to limit peri-procedural contrast use, but <12 months prior to the procedure)

Exclusion Criteria:

• Patients with a creatinine greater than 2.0 mg/dL
• Exclude patients whom in the Investigator's opinion, are hemodynamically unstable on the day of the procedure.
• Untreatable allergy to contrast media
• Patients who have undergone CT angiography within 48 hours of index PCI procedure
• Patients with chronic total occlusions (CTOs) requiring intervention.
• Patients requiring treatment for lesions other than the single bifurcated or single non-CTO complex lesion.