Stereotaxis Computed Tomography (CT) Co-Registration Study

Stereotaxis4 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Coronary Artery Disease

Interventions

Percutaneous coronary interventionPROCEDURE

non surgical procedure to open blocked coronary arteries

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

New York Presbyterian Hospital-Columbia Medical Center

New York, New York, United States

Outcomes

Primary Outcomes

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

Time frame: 6 months

Secondary Outcomes

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

Data from ClinicalTrials.gov

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