Stereotaxis Computed Tomography (CT) Co-Registration Study

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00994331
• Other study ID #: PM-CLIN-011
• Status: Terminated
• Phase: N/A
• First received: October 9, 2009
• Last updated: March 8, 2011
• Start date: October 2009
• Est. completion date: March 2011

Study information

• Verified date: March 2011
• Source: Stereotaxis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Procedure:
• Percutaneous coronary intervention
non surgical procedure to open blocked coronary arteries

Locations

Country	Name	City	State
United States	New York Presbyterian Hospital-Columbia Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Stereotaxis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoint is to compare and evaluate the total contrast use between Groups A, B and C .		6 months	No
Secondary	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	No