Clinical trial NCT02144090: Opsens Optowire for Fractional Flow Reserve - The O2 Pilot Study
Official title: Opsens Optowire for Fractional Flow Reserve - The O2 Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stable Angina
Unstable Angina Pectoris
Chest Pain
Ischemia
Keywords: Angiography
Angioplasty
Coronary artery disease
Diagnostic
Fractional flow reserve
Lead sponsor: Laval University
Sponsor class: OTHER
Collaborators: name: Opsens, Inc.
name: International Chair on Interventional Cardiology and Transradial Approach
First posted: 2014-05-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Safety and handling assessment of the Optowire
timeFrame: Patients will be followed through removal of the OptoWire from percutaneous insertion site and completion of the cardiac catheterization procedure (expected average <1hr)
Secondary outcomes:
measure: Comparison of FFR values measured with Optowire vs. with FFR guide wire used in standard practice
timeFrame: Patients will be followed through removal of the OptoWire from percutaneous insertion site and completion of the cardiac catheterization procedure (expected average <1hr)
Other outcomes:
Locations:
city: Quebec
country: Canada
facility: IUCPQ - Laval Hospital
Study officials:
affiliation: International Chair on Interventional Cardiology and Transradial Approach
name: Olivier F Bertrand, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: