Coronary Artery DiseaseNCT00994331
Stereotaxis Computed Tomography (CT) Co-Registration Study
A study testing Percutaneous coronary intervention in people with Coronary Artery Disease, run by Stereotaxis at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Percutaneous coronary intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Mar 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York Presbyterian Hospital-Columbia Medical Center
New York, New York, 10032
About this study
Official title: 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.
- Conditions
- Coronary Artery Disease
- Being tested
- Percutaneous coronary intervention
- Keywords
- Percutaneous Coronary Intervention, Magnetic Navigation, Computed Tomography
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous coronary interventionProcedure or surgery
non surgical procedure to open blocked coronary arteries
| Study group | Role | What they receive |
|---|---|---|
| Group A-CT Coregistration | Active comparator | 5 subjects with CT co-registration in a magnetically navigated PCI (Group A) Receives: Procedure: Percutaneous coronary intervention |
| Group B-Angiographic | Active comparator | 5 subjects with angiographic co-registration in a magnetically navigated PCI (Group B) Receives: Procedure: Percutaneous coronary intervention |
| Group C-Standard Angiography | Active comparator | 5 subjects with standard angiography in a conventional PCI (Group C) Receives: Procedure: Percutaneous coronary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is to compare and evaluate the total contrast use between Groups A, B and C .
Measured: 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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionMar 2011
- Study completionMar 2011
Why it stopped: Study terminated due to lack of enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stereotaxis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jeffrey Moses, MD, Principal investigator, New York Presbyterian Hospital-Columbia Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00994331
- Sponsor's protocol ID
- PM-CLIN-011
- Status last verified
- Mar 2011
- First submitted
- 9 Oct 2009
- Last updated
- 10 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00994331
- Acronym / sponsor ID
- PM-CLIN-011
- Conditions
- Coronary Artery Disease
- Keywords
- Percutaneous Coronary Intervention, Magnetic Navigation, Computed Tomography
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated due to lack of enrollment.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- StereotaxisIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 14 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A-CT Coregistration | Active comparator | Procedure: Percutaneous coronary intervention5 subjects with CT co-registration in a magnetically navigated PCI (Group A) |
| Group B-Angiographic | Active comparator | Procedure: Percutaneous coronary intervention5 subjects with angiographic co-registration in a magnetically navigated PCI (Group B) |
| Group C-Standard Angiography | Active comparator | Procedure: Percutaneous coronary intervention5 subjects with standard angiography in a conventional PCI (Group C) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous coronary interventionnon surgical procedure to open blocked coronary arteries | Procedure or surgery | Group A-CT Coregistration, Group B-Angiographic, Group C-Standard Angiography |
Primary outcome
The primary endpoint is to compare and evaluate the total contrast use between Groups A, B and C .
Time frame: 6 months
1 secondary outcome
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
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Study terminated due to lack of enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey Moses, MD principal investigator
New York Presbyterian Hospital-Columbia Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous coronary intervention in people with Coronary Artery Disease, run by Stereotaxis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study terminated due to lack of enrollment.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint is to compare and evaluate the total contrast use between Groups A, B and C . (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2011; AzTrials last refreshed its copy on 27 Oct 2026.