Opsens Optowire for Fractional Flow Reserve - The O2 Pilot Study

Laval University

Status: Completed

Conditions: Unstable Angina Pectoris; Stable Angina; Ischemia; Chest Pain

Treatments: Device: Fractional flow reserve measurement

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02144090

O2 Pilot Study

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Fractional flow reserve

Experimental group

Description:

Fractional flow reserve measurement

Treatment:

Device: Fractional flow reserve measurement