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Stereotaxis Computed Tomography (CT) Co-Registration Study

Sponsor
Stereotaxis (Industry)
Overall Status
Terminated
CT.gov ID
NCT00994331
Collaborator
(none)
4
Enrollment
1
Location
3
Arms
17
Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Percutaneous coronary intervention
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
4 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
None (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
Study Start Date :
Oct 1, 2009
Actual Primary Completion Date :
Mar 1, 2011
Actual Study Completion Date :
Mar 1, 2011

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. The primary endpoint is to compare and evaluate the total contrast use between Groups A, B and C . [6 months]

Secondary Outcome Measures

  1. 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00994331
Other Study ID Numbers:
  • PM-CLIN-011
First Posted:
Oct 14, 2009
Last Update Posted:
Mar 10, 2011
Last Verified:
Mar 1, 2011
Keywords provided by , ,
Percutaneous Coronary Intervention
Magnetic Navigation
Computed Tomography
Additional relevant MeSH terms:
Coronary Artery Disease

Study Results

No Results Posted as of Mar 10, 2011