Stereotaxis Computed Tomography (CT) Co-Registration Study
NCT ID: NCT00994331
Last Updated: 2011-03-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
4 participants
INTERVENTIONAL
2009-10-31
2011-03-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Group A-CT Coregistration
5 subjects with CT co-registration in a magnetically navigated PCI (Group A)
Percutaneous coronary intervention
non surgical procedure to open blocked coronary arteries
Group B-Angiographic
5 subjects with angiographic co-registration in a magnetically navigated PCI (Group B)
Percutaneous coronary intervention
non surgical procedure to open blocked coronary arteries
Group C-Standard Angiography
5 subjects with standard angiography in a conventional PCI (Group C)
Percutaneous coronary intervention
non surgical procedure to open blocked coronary arteries
Interventions
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Percutaneous coronary intervention
non surgical procedure to open blocked coronary arteries
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
80 Years
ALL
No
Sponsors
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Stereotaxis
INDUSTRY
Responsible Party
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Stereotaxis, Inc
Principal Investigators
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Jeffrey Moses, MD
Role: PRINCIPAL_INVESTIGATOR
New York Presbyterian Hospital-Columbia Medical Center
Locations
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New York Presbyterian Hospital-Columbia Medical Center
New York, New York, United States
Countries
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Other Identifiers
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PM-CLIN-011
Identifier Type: -
Identifier Source: org_study_id
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