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Stereotaxis Computed Tomography (CT) Co-Registration Study

Primary Purpose

Coronary Artery Disease

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Percutaneous coronary intervention
Sponsored by
Stereotaxis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Percutaneous Coronary Intervention, Magnetic Navigation, Computed Tomography

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • New York Presbyterian Hospital-Columbia Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Group A-CT Coregistration

Group B-Angiographic

Group C-Standard Angiography

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

The primary endpoint is to compare and evaluate the total contrast use between Groups A, B and C .

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

Full Information

First Posted
October 9, 2009
Last Updated
March 8, 2011
Sponsor
Stereotaxis
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1. Study Identification

Unique Protocol Identification Number
NCT00994331
Brief Title
Stereotaxis Computed Tomography (CT) Co-Registration Study
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 Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Terminated
Why Stopped
Study terminated due to lack of enrollment.
Study Start Date
October 2009 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Stereotaxis

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Percutaneous Coronary Intervention, Magnetic Navigation, Computed Tomography

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A-CT Coregistration
Arm Type
Active Comparator
Arm Description
5 subjects with CT co-registration in a magnetically navigated PCI (Group A)
Arm Title
Group B-Angiographic
Arm Type
Active Comparator
Arm Description
5 subjects with angiographic co-registration in a magnetically navigated PCI (Group B)
Arm Title
Group C-Standard Angiography
Arm Type
Active Comparator
Arm Description
5 subjects with standard angiography in a conventional PCI (Group C)
Intervention Type
Procedure
Intervention Name(s)
Percutaneous coronary intervention
Intervention Description
non surgical procedure to open blocked coronary arteries
Primary Outcome Measure Information:
Title
The primary endpoint is to compare and evaluate the total contrast use between Groups A, B and C .
Time Frame
6 months
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey Moses, MD
Organizational Affiliation
New York Presbyterian Hospital-Columbia Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York Presbyterian Hospital-Columbia Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

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Stereotaxis Computed Tomography (CT) Co-Registration Study

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