Stereotaxis Computed Tomography (CT) Co-Registration Study

Study Overview
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Brief Summary
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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 Navigant™ provides clinical benefits for percutaneous coronary intervention (PCI) by decreasing the amount of contrast used during complex PCI procedures.

Official Title
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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

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Procedure: Percutaneous coronary intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A-CT Coregistration<br>5 subjects with CT co-registration in a magnetically navigated PCI (Group A) | Procedure: Percutaneous coronary intervention<br>* non surgical procedure to open blocked coronary arteries<br>|
| Active Comparator: Group B-Angiographic<br>5 subjects with angiographic co-registration in a magnetically navigated PCI (Group B) | Procedure: Percutaneous coronary intervention<br>* non surgical procedure to open blocked coronary arteries<br>|
| Active Comparator: Group C-Standard Angiography<br>5 subjects with standard angiography in a conventional PCI (Group C) | Procedure: Percutaneous coronary intervention<br>* non surgical procedure to open blocked coronary arteries<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoint is to compare and evaluate the total contrast use between Groups A, B and C . |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Percutaneous Coronary Intervention, Magnetic Navigation, Computed Tomography