Stereotaxis Computed Tomography (CT) Co-Registration Study
Stopped early · Not applicable
Conditions studied: Coronary Artery Disease
In brief
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.
Key facts
- Study ID
- NCT00994331
- Run by
- Stereotaxis
- People needed
- 4
- Starts
- 2009-10-01
- Expected to finish
- 2011-03-01
- Last updated by the study team
- 2011-03-10
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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.
Where it is running
- New York Presbyterian Hospital-Columbia Medical Center — New York, New York, United States
Full record on ClinicalTrials.gov
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