Coronary DiseaseDEFINE REALNCT02281110
The REAL Registry for Utilization of iFR in Assessing Coronary Stenoses
An observational study of Coronary Disease, run by Volcano Corporation at 1 site in Belgium.
Trial summary
The purpose of this registry is to collect real life information and to document the performance and user friendliness of iFR in daily diagnostic practice and treatment strategies for MVD patients undergoing cardiac catheterization. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Disease
- What is being tested?
- iFR/FFR
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 1 siteBelgium
- Study dates
- Jul 2014to Dec 2015
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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
Study population: Eligibility includes adults undergoing coronary angiography and/or PCI
Who may be able to join
- Over 18 year of age
- Willing to participate and able to understand, read and sign the informed consent document before the planned procedure
- Eligible for coronary angiography and PCI
- Coronary artery disease with at least two or more visually assessed coronary stenoses (greater than 40% diameter stenosis) in native, major epicardial vessel or its branches by coronary angiogram with an indication of physiological assessment.
Who cannot join
- Inability to obtain a signed informed consent from potential patient.
- Any contraindication for functional assessment as per the instructions per use and determined by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Observational, Non-randomized European, Multi-center Registry Collecting Real Life Information for the Utilization of Instantaneous Wave Free Ratio in Assessing Coronary Stenosis Relevance in the Multi-vessel Disease Patients Population.
The purpose of this registry is to collect real life information and to document the performance and user friendliness of iFR in daily diagnostic practice and treatment strategies for MVD patients undergoing cardiac catheterization.
Read the detailed description
The REAL Registry will enroll a maximum of 3,000 patients in approximately 300 sites across multiple European and Middle East countries, where product has received CE approval and is marketed. An average of 10 cases with a maximum of 50 patients will be enrolled per participating site.
No follow-up will be performed. The REAL Registry will only collect data during diagnostic angiogram or PCI procedure, when performed.
- Conditions
- Coronary Disease
- Being tested
- iFR/FFR
- Keywords
- Diagnostic coronary catheterization, Multi-vessel coronary disease, Percutaneous Coronary Intervention, Instantaneous wave free ratio, Fractional flow reserve
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iFR/FFRDevice
Also called instant flow reserve/fractional flow reserve
- The Volcano iFR®-FFR option, which is a measurement modality for the Volcano system that provides the capability to make FFR and instantaneous wave-Free Ratio™ (iFR®) measurements (CE-Marked). iFR® is a pressure-derived, hyperemia-free index for the assessment of coronary stenosis relevance. This option consists of an FFR-iFR® specific patient interface module (PIM-FFR) which can be connected to the Volcano system - VOLCANO s5 or s5i™ platform equipped with iFR® option. This PIM-FFR is compatible with all Volcano pressure measurement guide wires.
| Study group | Role | What they receive |
|---|---|---|
| iFR/FFR assessment | Patients enrolled into this prospective registry will be derived from Stable Coronary Artery disease or Acute Coronary Syndrome (ACS) population undergoing cardiac catheterization. Patients with ACS may be evaluated by functional assessment in the non-culprit stenosis during the index PCI revascularization or in a staged procedure. The registry will enroll patients in whom physiological assessment (iFR/FFR) is particularly helpful in identifying haemodynamically significant stenosis: MVD patients defined by patients with lesions > 40% and <100% in 2 or more vessels. Receives: Device: iFR/FFR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemodynamic severity (Percentage of stenosis properly classified by iFR®)
Percentage of stenosis properly classified by iFR® in terms of hemodynamic severity compare to FFR in MVD patients. Hemodynamic severity will be established with an FFR value <=0,80.
Measured: Day 1 (Post-Procedure)
Secondary outcomes (2)
changes in iFR® and FFR
Changes in iFR® and FFR pre angioplasty and post angioplasty in MVD patients.
Measured: Day 1 (Post-Procedure)
Changes to decision strategy of revascularization
Percentage of MVD patients in whom the decision strategy of revascularization changed after iFR® compare to the decision based on diagnostic angiogram only.
Measured: Day 1 (Post-Procedure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2014 (estimated)
- Study startJul 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary DiseaseStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Volcano Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02281110
- Sponsor's protocol ID
- 2014-CV-001
- Acronym
- DEFINE REAL
- Status last verified
- May 2016
- First submitted
- 1 Oct 2014
- Last updated
- 10 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Observational, Non-randomized European, Multi-center Registry Collecting Real Life Information for the Utilization of Instantaneous Wave Free Ratio in Assessing Coronary Stenosis Relevance in the Multi-vessel Disease Patients Population.
- ClinicalTrials.gov ID
- NCT02281110
- Acronym / sponsor ID
- DEFINE REAL / 2014-CV-001
- Conditions
- Coronary Disease
- Keywords
- Diagnostic coronary catheterization, Multi-vessel coronary disease, Percutaneous Coronary Intervention, Instantaneous wave free ratio, Fractional flow reserve
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Volcano CorporationIndustry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 3 Nov 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 registry is to collect real life information and to document the performance and user friendliness of iFR in daily diagnostic practice and treatment strategies for MVD patients undergoing cardiac catheterization.
Detailed description
The REAL Registry will enroll a maximum of 3,000 patients in approximately 300 sites across multiple European and Middle East countries, where product has received CE approval and is marketed. An average of 10 cases with a maximum of 50 patients will be enrolled per participating site.
No follow-up will be performed. The REAL Registry will only collect data during diagnostic angiogram or PCI procedure, when performed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| iFR/FFR assessment | – | Device: iFR/FFRPatients enrolled into this prospective registry will be derived from Stable Coronary Artery disease or Acute Coronary Syndrome (ACS) population undergoing cardiac catheterization. Patients with ACS may be evaluated by functional assessment in the non-culprit stenosis during the index PCI revascularization or in a staged procedure. The registry will enroll patients in whom physiological assessment (iFR/FFR) is particularly helpful in identifying haemodynamically significant stenosis: MVD patients defined by patients with lesions > 40% and <100% in 2 or more vessels. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligibility includes adults undergoing coronary angiography and/or PCI
Key inclusion criteria (4 listed)
- Over 18 year of age
- Willing to participate and able to understand, read and sign the informed consent document before the planned procedure
- Eligible for coronary angiography and PCI
- Coronary artery disease with at least two or more visually assessed coronary stenoses (greater than 40% diameter stenosis) in native, major epicardial vessel or its branches by coronary angiogram with an indication of physiological assessment.
Key exclusion criteria (2 listed)
- Inability to obtain a signed informed consent from potential patient.
- Any contraindication for functional assessment as per the instructions per use and determined by the investigator.
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 |
|---|---|---|
| iFR/FFRAlso: instant flow reserve/fractional flow reserve• The Volcano iFR®-FFR option, which is a measurement modality for the Volcano system that provides the capability to make FFR and instantaneous wave-Free Ratio™ (iFR®) measurements (CE-Marked). iFR® is a pressure-derived, hyperemia-free index for the assessment of coronary stenosis relevance. This option consists of an FFR-iFR® specific patient interface module (PIM-FFR) which can be connected to the Volcano system - VOLCANO s5 or s5i™ platform equipped with iFR® option. This PIM-FFR is compatible with all Volcano pressure measurement guide wires. | Device | iFR/FFR assessment |
Primary outcome
Hemodynamic severity (Percentage of stenosis properly classified by iFR®)
Time frame: Day 1 (Post-Procedure)
Percentage of stenosis properly classified by iFR® in terms of hemodynamic severity compare to FFR in MVD patients. Hemodynamic severity will be established with an FFR value <=0,80.
2 secondary outcomes
changes in iFR® and FFR
Time frame: Day 1 (Post-Procedure)
Changes to decision strategy of revascularization
Time frame: Day 1 (Post-Procedure)
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 May 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Disease, run by Volcano Corporation at 1 site in Belgium.
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 4 inclusion and 2 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 May 2016. 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 Belgium. 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?
Hemodynamic severity (Percentage of stenosis properly classified by iFR®) (time frame: Day 1 (Post-Procedure)). 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 May 2016.