Opsens Optowire for Fractional Flow Reserve - The O2 Pilot Study

NCT ID: NCT02144090

Last Updated: 2015-07-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2015-05-31

Brief 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.

Detailed 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.

Conditions

Stable Angina; Unstable Angina Pectoris; Chest Pain; Ischemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Fractional flow reserve

Fractional flow reserve measurement

Group Type: EXPERIMENTAL

Fractional flow reserve measurement

Intervention Type: DEVICE

Fractional flow reserve measurement

Interventions

Fractional flow reserve measurement

Fractional flow reserve measurement

Intervention Type: DEVICE

Other Intervention Names

Opsens Optowire and Optomonitor

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Opsens, Inc.

INDUSTRY

Sponsor Role: collaborator

International Chair on Interventional Cardiology and Transradial Approach

OTHER

Sponsor Role: collaborator

Laval University

OTHER

Sponsor Role: lead

Responsible Party

Olivier F. Bertrand

Study Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Olivier F Bertrand, MD PhD

Role: PRINCIPAL_INVESTIGATOR

International Chair on Interventional Cardiology and Transradial Approach

Locations

IUCPQ - Laval Hospital

Québec, Quebec, Canada

Countries

Canada

Other Identifiers

O2 Pilot Study

Identifier Type: -

Identifier Source: org_study_id