Stereotaxis Computed Tomography (CT) Co-Registration Study

Not Applicable

Terminated

• Conditions: Coronary Artery Disease
• Interventions: Procedure: Percutaneous coronary intervention

• Registration Number: NCT00994331
• Lead Sponsor: Stereotaxis

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-10-09
• Study First Submitted QC: 2009-10-13
• Study First Posted: 2009-10-14
• Status Verified: 2011-03
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Last Update Submitted: 2011-03-08
• Last Update Posted: 2011-03-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Group A-CT Coregistration	Percutaneous coronary intervention	5 subjects with CT co-registration in a magnetically navigated PCI (Group A)
Group B-Angiographic	Percutaneous coronary intervention	5 subjects with angiographic co-registration in a magnetically navigated PCI (Group B)
Group C-Standard Angiography	Percutaneous coronary intervention	5 subjects with standard angiography in a conventional PCI (Group C)

Primary Outcome Measures

Name	Time	Method
The primary endpoint is to compare and evaluate the total contrast use between Groups A, B and C .	6 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

New York Presbyterian Hospital-Columbia Medical Center; 🇺🇸 New York, New York, United States