Opsens Optowire for Fractional Flow Reserve - The O2 Pilot Study

Chest Pain Clinical Trial

— O2  

Official title:

Opsens Optowire for Fractional Flow Reserve - The O2 Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02144090
• Other study ID #: O2 Pilot Study
• Status: Completed
• Phase: N/A
• First received: May 15, 2014
• Last updated: July 9, 2015
• Start date: May 2014
• Est. completion date: May 2015

Study information

• Verified date: July 2015
• Source: Laval University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Angina Pectoris
• Angina, Stable
• Angina, Unstable
• Chest Pain
• Ischemia
• Stable Angina
• Unstable Angina Pectoris

Intervention

Device:
• Fractional flow reserve measurement
Fractional flow reserve measurement

Locations

Country	Name	City	State
Canada	IUCPQ - Laval Hospital	Quebec

Sponsors (3)

Lead Sponsor	Collaborator
Laval University	International Chair on Interventional Cardiology and Transradial Approach, Opsens Medical

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and handling assessment of the Optowire	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	Patients will be followed through removal of the OptoWire from percutaneous insertion site and completion of the cardiac catheterization procedure (expected average <1hr)	Yes
Secondary	Comparison of FFR values measured with Optowire vs. with FFR guide wire used in standard practice	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.	Patients will be followed through removal of the OptoWire from percutaneous insertion site and completion of the cardiac catheterization procedure (expected average <1hr)	No