Stereotaxis Computed Tomography (CT) Co-Registration Study

S

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

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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