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Stereotaxis Computed Tomography (CT) Co-Registration Study

This study has been terminated.
(Study terminated due to lack of enrollment.)
Sponsor:
Information provided by:
Stereotaxis
ClinicalTrials.gov Identifier:
NCT00994331
First received: October 9, 2009
Last updated: March 8, 2011
Last verified: March 2011
History of Changes
  Purpose

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.


Condition Intervention
Coronary Artery Disease
 Procedure: Percutaneous coronary intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Stereotaxis:

Primary Outcome Measures:
  • The primary endpoint is to compare and evaluate the total contrast use between Groups A, B and C . [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 4
Study Start Date: October 2009
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group A-CT Coregistration
5 subjects with CT co-registration in a magnetically navigated PCI (Group A)
 Procedure: Percutaneous coronary intervention
non surgical procedure to open blocked coronary arteries
Active Comparator: Group B-Angiographic
5 subjects with angiographic co-registration in a magnetically navigated PCI (Group B)
 Procedure: Percutaneous coronary intervention
non surgical procedure to open blocked coronary arteries
Active Comparator: Group C-Standard Angiography
5 subjects with standard angiography in a conventional PCI (Group C)
 Procedure: Percutaneous coronary intervention
non surgical procedure to open blocked coronary arteries

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00994331

Locations
United States, New York
New York Presbyterian Hospital-Columbia Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Stereotaxis
Investigators
Principal Investigator: Jeffrey Moses, MD New York Presbyterian Hospital-Columbia Medical Center
  More Information

No publications provided

Responsible Party: Patricia Gipson, Stereotaxis, Inc
ClinicalTrials.gov Identifier: NCT00994331     History of Changes
Other Study ID Numbers: PM-CLIN-011
Study First Received: October 9, 2009
Last Updated: March 8, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Stereotaxis:
Percutaneous Coronary Intervention
Magnetic Navigation
Computed Tomography

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 19, 2013