Stable AnginaO2NCT02144090
Opsens Optowire for Fractional Flow Reserve - The O2 Pilot Study
A study testing Fractional flow reserve measurement in people with Stable Angina and Unstable Angina Pectoris, run by Laval University at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stable Angina, Unstable Angina Pectoris, Chest Pain
- What is being tested?
- Fractional flow reserve measurement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- May 2014to May 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Lesions with angiographic 'haziness' or suspected to contain thrombus
- Post-coronary artery bypass grafting
- Total occlusion
- If use of atherectomy device is indicated
Trial locations and contacts
1 site in 1 country.
About this 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.
Read the 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
- Being tested
- Fractional flow reserve measurement
- Keywords
- Angiography, Angioplasty, Coronary artery disease, Diagnostic, Fractional flow reserve
- Medical subject headings
- Angina, Stable, Angina, Unstable, Chest Pain, Ischemia, Coronary Artery Disease, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fractional flow reserve measurementDevice
Also called Opsens Optowire and Optomonitor
Fractional flow reserve measurement
| Study group | Role | What they receive |
|---|---|---|
| Fractional flow reserve | Experimental | Fractional flow reserve measurement Receives: Device: Fractional flow reserve measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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 (1)
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.
Measured: Patients will be followed through removal of the OptoWire from percutaneous insertion site and completion of the cardiac catheterization procedure (expected average <1hr)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2014 (estimated)
- Study startMay 2014
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stable AnginaStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- Opsens, Inc., International Chair on Interventional Cardiology and Transradial Approach
- Responsible party
- Principal investigator, Olivier F. Bertrand, Laval University
- Investigators
- Olivier F Bertrand, MD PhD, Principal investigator, International Chair on Interventional Cardiology and Transradial Approach
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02144090
- Sponsor's protocol ID
- O2 Pilot Study
- Acronym
- O2
- Status last verified
- Jul 2015
- First submitted
- 15 May 2014
- Last updated
- 10 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opsens Optowire for Fractional Flow Reserve - The O2 Pilot Study
- ClinicalTrials.gov ID
- NCT02144090
- Acronym / sponsor ID
- O2 / O2 Pilot Study
- Conditions
- Stable Angina, Unstable Angina Pectoris, Chest Pain, Ischemia
- Keywords
- Angiography, Angioplasty, Coronary artery disease, Diagnostic, Fractional flow reserve
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- Opsens, Inc., International Chair on Interventional Cardiology and Transradial Approach
- Study start
- May 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 21 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fractional flow reserve | Experimental | Device: Fractional flow reserve measurementFractional flow reserve measurement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with
- 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
Key exclusion criteria (4 listed)
- Lesions with angiographic 'haziness' or suspected to contain thrombus
- Post-coronary artery bypass grafting
- Total occlusion
- If use of atherectomy device is indicated
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fractional flow reserve measurementAlso: Opsens Optowire and OptomonitorFractional flow reserve measurement | Device | Fractional flow reserve |
Primary outcome
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)
1. Safely reach and cross a target lesion; 2. perform an FFR measurement using the Optowire and Optomonitor according to the product user guide; 3. disconnect the proximal connector on the OptoWire during the procedure, placing an interventional device (if necessary), and reconnecting the Optowire proximal connector; 4. safely remove the Optowire from the coronary artery. Dedicated questionnaires will be used for such assessment
1 secondary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2015.
Related trials for Stable Angina
Recruiting
Intracoronary Cryotherapy Effect on Stabilization of Vulnerable Plaque in Patients With Stable Angina or ACS - A Traditional Feasibility Study
Coronary Arterial Disease (CAD), Plaque
Recruiting
Multivessel Balloon Occlusion to Investigate Obstructive Coronary Artery Disease and aNgina
Stable Angina, Multivessel Coronary Artery Disease
Recruiting
Study of Lesion-Specific Invasive Haemodynamic Angina Thresholds
Angina (Stable), Coronary Artery Disease(CAD)
Active, not recruitingObservational study
REDUCER-I: An Observational Study of the Neovasc Reducer™ System
Angina Pectoris, Angina Pectoris, Stable
RecruitingObservational study
Identification of Lesion Characteristics in Coronary Plaques Using Multimodality Intravascular Imaging and Novel Photon-counting CT in Stable Angina
Coronary Artery Disease (CAD), Stable Angina Pectoris
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olivier F Bertrand, MD PhD principal investigator
International Chair on Interventional Cardiology and Transradial Approach
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fractional flow reserve measurement in people with Stable Angina and Unstable Angina Pectoris, run by Laval University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2015.