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NCT Number: NCT02144090

Opsens Optowire for Fractional Flow Reserve - The O2 Pilot Study

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.

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Key information

Conditions

Stable Angina Angina Pectoris Angina, Stable Angina, Unstable Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Chest Pain Coronary Artery Disease Coronary Disease Disease Heart Diseases Ischemia Myocardial Ischemia Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Unstable Angina Pectoris Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IUCPQ - Laval Hospital

Québec, Quebec, G1V 4G5, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with
  • Stable angina or,
  • Unstable angina pectoris or,
  • Atypical chest pain or no chest pain but with suspected ischemia
  • At least one moderate lesion in native coronary artery thought to produce ischemia
  • Operator and patient agree for procedures
  • Patient (> 18 years) has signed a written informed consent prior to procedure

Exclusion criteria

  • Lesions with angiographic 'haziness' or suspected to contain thrombus
  • Post-coronary artery bypass grafting
  • Total occlusion
  • If use of atherectomy device is indicated

Treatment and study plan

Fractional flow reserve measurement

Device

Fractional flow reserve measurement

Other names: Opsens Optowire and Optomonitor

Primary outcomes

  1. Safety and handling assessment of the Optowire

    Time frame: Patients will be followed through removal of the OptoWire from percutaneous insertion site and completion of the cardiac catheterization procedure (expected average <1hr)

    • Safely reach and cross a target lesion;
    • perform an FFR measurement using the Optowire and Optomonitor according to the product user guide;
    • disconnect the proximal connector on the OptoWire during the procedure, placing an interventional device (if necessary), and reconnecting the Optowire proximal connector;
    • safely remove the Optowire from the coronary artery.

    Dedicated questionnaires will be used for such assessment

Secondary outcomes

  1. Comparison of FFR values measured with Optowire vs. with FFR guide wire used in standard practice

    Time frame: Patients will be followed through removal of the OptoWire from percutaneous insertion site and completion of the cardiac catheterization procedure (expected average <1hr)

    In selected cases, the operator may choose to perform FFR measurements using currently approved FFR wires. Values obtained with standard FFR wires and Optowire may therefore be compared.

Sponsors and collaborators

Lead sponsor

Laval University

Other

Collaborators

  • International Chair on Interventional Cardiology and Transradial Approach
  • Opsens, Inc.

Registry information

Acronym: O2

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
May 21, 2014
Registry last updated
Jul 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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