Study Stopped
Study terminated due to lack of enrollment.
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
1 other identifier
interventional
4
1 country
1
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable coronary-artery-disease
Started Oct 2009
Shorter than P25 for not_applicable coronary-artery-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 9, 2009
CompletedFirst Posted
Study publicly available on registry
October 14, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedMarch 10, 2011
March 1, 2011
1.4 years
October 9, 2009
March 8, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary endpoint is to compare and evaluate the total contrast use between Groups A, B and C .
6 months
Secondary Outcomes (1)
The secondary endpoint is to compare and evaluate the following data points between Groups A, B and C: fluoroscopy time, procedure time, crossing time, procedural contrast use, adverse events (AEs): e.g. clinically significant perforations
6 months
Study Arms (3)
Group A-CT Coregistration
ACTIVE COMPARATOR5 subjects with CT co-registration in a magnetically navigated PCI (Group A)
Group B-Angiographic
ACTIVE COMPARATOR5 subjects with angiographic co-registration in a magnetically navigated PCI (Group B)
Group C-Standard Angiography
ACTIVE COMPARATOR5 subjects with standard angiography in a conventional PCI (Group C)
Interventions
non surgical procedure to open blocked coronary arteries
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Stereotaxislead
Study Sites (1)
New York Presbyterian Hospital-Columbia Medical Center
New York, New York, 10032, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jeffrey Moses, MD
New York Presbyterian Hospital-Columbia Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 9, 2009
First Posted
October 14, 2009
Study Start
October 1, 2009
Primary Completion
March 1, 2011
Study Completion
March 1, 2011
Last Updated
March 10, 2011
Record last verified: 2011-03