Status:
TERMINATED
Stereotaxis Computed Tomography (CT) Co-Registration Study
Lead Sponsor:
Stereotaxis
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT00994331
Start Date
October 1 2009
End Date
March 1 2011
Last Update
March 10 2011
Active Locations (1)
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1
New York Presbyterian Hospital-Columbia Medical Center
New York, New York, United States, 10032