Stereotaxis Computed Tomography (CT) Co-Registration Study

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00994331

Enrollment

Registered

2009-10-14

Start date

2009-10-31

Completion date

2011-03-31

Last updated

2011-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Keywords

Percutaneous Coronary Intervention, Magnetic Navigation, Computed Tomography

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.

Interventions

PROCEDUREPercutaneous coronary intervention

non surgical procedure to open blocked coronary arteries

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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.

Design outcomes

Primary

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

Secondary

Measure	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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026