Clinical Trials Logo

Clinical Trial Summary

The purpose of this study is to assess the usability and safety of the Opsens OptoWire and Optomonitor in measuring fractional flow reserve (FFR) in patients with coronary artery disease who are undergoing a coronary angiogram.


Clinical Trial Description

Fractional flow reserve (FFR) measurement involves determining the ratio between the maximum achievable blood flow in a diseased coronary artery and the theoretical maximum flow in a normal coronary artery. An FFR of 1.0 is widely accepted as normal. An FFR value lower than 0.75 - 0.80 is generally considered to be associated with myocardial ischemia (MI).

FFR is easily measured during routine coronary angiography by using a pressure wire to calculate the ratio between coronary pressure distal to a coronary artery stenosis and aortic pressure under conditions of maximum myocardial hyperemia. This ratio represents the potential decrease in coronary flow distal to the coronary stenosis.

Over the past decade, FFR measurement has been increasingly used in cardiac catheterization laboratories. It provides a quantitative assessment of the functional severity of a coronary artery stenosis identified during coronary angiography and cardiac catheterization.

Opsens, Inc. has developed a new pressure wire for use in determining FFR in coronary arteries; the OptoWire. The OptoWire is an instrumented guide wire with a fiber optic pressure sensor mounted 3.5 cm proximal to the tip. The Optowire measures blood pressure during diagnostic and/or interventional procedures when used in combination with the OptoMonitor.

The O2 study is a pilot study which aims to provide preliminary experience in human patients with coronary artery disease. The study data will also be used as part of design validation.

The O2 study is a prospective single arm study designed to assess the usability, functionality, and safety of the Optowire and Optomonitor in patients. ;


Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


NCT number NCT02144090
Study type Interventional
Source Laval University
Contact
Status Completed
Phase N/A
Start date May 2014
Completion date May 2015

See also
  Status Clinical Trial Phase
Completed NCT04153006 - Comparison of Fingerstick Versus Venous Sample for Troponin I.
Recruiting NCT03664973 - Serratus Plane Block for Rib Fractures N/A
Completed NCT02905383 - The Effect of Exercise on Physical Function and Health in Older People After Discharge From Hospital N/A
Not yet recruiting NCT05649891 - Checklists Resuscitation Emergency Department N/A
Withdrawn NCT03906812 - A Randomized Trial of Telemetry Compared With Unmonitored Floor Admissions in ED Patients With Low-Risk Chest Pain N/A
Active, not recruiting NCT02892903 - In the Management of Coronary Artery Disease, Does Routine Pressure Wire Assessment at the Time of Coronary Angiography Affect Management Strategy, Hospital Costs and Outcomes? N/A
Completed NCT02538861 - Acute Chest Pain Imaging in the ED With the Combine CCTA and CT Perfusion
Completed NCT02538770 - Rapid Viral Diagnostics in Adults to Reduce Antimicrobial Consumption and Duration of Hospitalization N/A
Completed NCT02440893 - Understanding the Effect of Metformin on Corus CAD (or ASGES)
Completed NCT01931852 - Cardiac Magnetic Resonance Imaging Strategy for the Management of Patients With Acute Chest Pain and Detectable to Elevated Troponin N/A
Completed NCT01665521 - Efficacy Evaluation of the HEART Pathway in Emergency Department Patients With Acute Chest Pain N/A
Recruiting NCT01542086 - Comparison of the Cost-Effectiveness of Coronary CT Angiography Versus Myocardial SPECT in Patients With Intermediate Risk of Coronary Heart Disease N/A
Completed NCT01604655 - ProspEctive First Evaluation in Chest Pain Trial N/A
Completed NCT01486030 - Effect of Exercise Stress Testing on Peripheral Gene Expression Using Corus CAD (or ASGES) Diagnostic Test
Terminated NCT01836211 - High-Sensitivity Troponin T and Coronary Computed Tomography Angiography for Rapid Diagnosis of Emergency Chest Pain N/A
Completed NCT01163019 - 2D Strain Echocardiography for Diagnosing Chest Pain in the Emergency Room N/A
Completed NCT00709670 - ComParative Diagnostic Study Between Multislice Computed Tomography (MSCT) and Stress Echography in Coronarin Patients. N/A
Completed NCT00536224 - Chest Pain Observation Unit Risk Reduction Trial N/A
Terminated NCT00221182 - Stem Cell Study for Patients With Heart Disease Phase 1/Phase 2
Completed NCT00075088 - Tele-Electrocardiography in Emergency Cardiac Care Phase 3