Opsens Optowire for Fractional Flow Reserve

Status Completed

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

Clinical Trial Details

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

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Opsens Optowire for Fractional Flow Reserve - The O2 Pilot Study — O2

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms