Stereotaxis Computed Tomography (CT) Co-Registration Study

Stereotaxis

Status: Terminated

Conditions: Coronary Artery Disease

Treatments: Procedure: Percutaneous coronary intervention

Study type: Interventional

Funder types: Industry

Identifiers

NCT00994331

PM-CLIN-011

Details and patient eligibility

About

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.

Enrollment: 4 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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4 participants in 3 patient groups

Group A-CT Coregistration

Active Comparator group

Description:

5 subjects with CT co-registration in a magnetically navigated PCI (Group A)

Treatment:

Procedure: Percutaneous coronary intervention

Group B-Angiographic

Active Comparator group

Description:

5 subjects with angiographic co-registration in a magnetically navigated PCI (Group B)

Treatment:

Procedure: Percutaneous coronary intervention

Group C-Standard Angiography

Active Comparator group

Description:

5 subjects with standard angiography in a conventional PCI (Group C)

Treatment:

Procedure: Percutaneous coronary intervention