Stereotaxis Computed Tomography (CT) Co-Registration Study

NCT ID: NCT00994331

Last Updated: 2011-03-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2011-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A-CT Coregistration

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

Group Type ACTIVE_COMPARATOR

Percutaneous coronary intervention

Intervention Type PROCEDURE

non surgical procedure to open blocked coronary arteries

Group B-Angiographic

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

Group Type ACTIVE_COMPARATOR

Percutaneous coronary intervention

Intervention Type PROCEDURE

non surgical procedure to open blocked coronary arteries

Group C-Standard Angiography

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

Group Type ACTIVE_COMPARATOR

Percutaneous coronary intervention

Intervention Type PROCEDURE

non surgical procedure to open blocked coronary arteries

Interventions

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Percutaneous coronary intervention

non surgical procedure to open blocked coronary arteries

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stereotaxis

INDUSTRY

Sponsor Role lead

Responsible Party

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Stereotaxis, Inc

Principal Investigators

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Jeffrey Moses, MD

Role: PRINCIPAL_INVESTIGATOR

New York Presbyterian Hospital-Columbia Medical Center

Locations

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New York Presbyterian Hospital-Columbia Medical Center

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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PM-CLIN-011

Identifier Type: -

Identifier Source: org_study_id

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