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Study terminated due to lack of enrollment.
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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 Navigantâ„¢ provides clinical benefits for percutaneous coronary intervention (PCI) by decreasing the amount of contrast used during complex PCI procedures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A-CT Coregistration | Active Comparator | 5 subjects with CT co-registration in a magnetically navigated PCI (Group A) |
|
| Group B-Angiographic | Active Comparator | 5 subjects with angiographic co-registration in a magnetically navigated PCI (Group B) |
|
| Group C-Standard Angiography | Active Comparator | 5 subjects with standard angiography in a conventional PCI (Group C) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous coronary intervention | Procedure | non surgical procedure to open blocked coronary arteries |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary endpoint is to compare and evaluate the total contrast use between Groups A, B and C . | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Moses, MD | New York Presbyterian Hospital-Columbia Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York Presbyterian Hospital-Columbia Medical Center | New York | New York | 10032 | United States |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D062645 | Percutaneous Coronary Intervention |
| ID | Term |
|---|---|
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D019060 | Minimally Invasive Surgical Procedures |