Multivessel Coronary Artery DiseaseFUTURENCT01881555
Functional Testing Underlying Coronary Revascularisation
A study testing invasive coronary angiography and Functional testing by fractional flow reserve measurement in people with Multivessel Coronary Artery Disease and Vessel Disease, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
The objective of this trial is to compare the clinical outcomes and cost-effectiveness of 2 therapeutic strategies, one based on coronary angiography guidance and the other based on coronary angiography with fractional flow reserve (FFR) in multivessel coronary artery disease patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multivessel Coronary Artery Disease, Vessel Disease, Stable Angina
- What is being tested?
- invasive coronary angiography and Functional testing by fractional flow reserve measurement
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 941 participants
- Where
- 1 siteFrance
- Study dates
- 27 May 2013to 10 Jun 2017
- 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
- age > 18
- referred to the cardiologist for one of the following medical condition :
- ST segment elevation myocardial infarction evolving for more than 7 days after revascularization of culprit coronary artery or
- no ST elevation acute coronary syndrome with or without troponin (T or I) elevation and medically stabilized for at least 12 hours or
- stable angina (CCS I, II or III) or
- chest pain diagnosis with suspicion of CAD or with ischemia certificated by non invasive tests.
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- patients with at least 2 vessel disease (≥50% stenosis on angiography) including the left anterior descending coronary artery or with single vessel disease on left main coronary artery
- Patient willing and able to provide informed, written consent
- Patient not under legal protection
- Patient benefiting from the French Health Insurance
Who cannot join
- Pregnancy, childbearing, absence of effective contraception
- Previous coronary bypass surgery
- Planned associated valvular surgery
- Life expectancy < 2 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: FUnctional Testing Underlying Coronary REvascularisation.
The objective of this trial is to compare the clinical outcomes and cost-effectiveness of 2 therapeutic strategies, one based on coronary angiography guidance and the other based on coronary angiography with fractional flow reserve (FFR) in multivessel coronary artery disease patients.
The trial is a prospective, multicenter, French, randomized clinical trial including men and women ≥ 18 years presenting with significant multivessel disease defined by coronary angiography as coronary narrowing > 50% diameter stenosis in at least 2 major epicardic vessels. The patients who give their informed consent will be randomly assigned to a therapeutic strategy based upon coronary angiography or angiography with FFR testing. In the FFR group, a significant coronary stenosis will be defined by a FFR ≤ 0.8. Based upon this multivessel evaluation (angiography or FFR), the investigator will choose the best therapeutic strategy to his discretion (medical optimal treatment, coronary stenting, coronary artery bypass graft surgery). The aim of revascularization procedures will be to obtain complete revascularization. In the FFR group, only stenosis with FFR≤0.8 will be treated.
Read more
The primary end point of the trial is a composite of major cardiovascular events including death from any cause, myocardial infarction, any hospitalization for coronary revascularization performed in addition to initial treatment and stroke at 1 year of follow-up.
Secondary end points will include adverse events, individual major cardiovascular events, stent thrombosis, bleeding events, occlusion of coronary artery bypass graft, patient's quality of life and cost-effectiveness and 30-day, 6 month, 2-year and 5-year outcomes.
- Conditions
- Multivessel Coronary Artery Disease, Vessel Disease, Stable Angina, Unstable Angina or Stabilized Non-ST Elevated Myocardial Infarction, Patients With ST-elevated Myocardial Infarction, Revascularization of Culprit Coronary Artery
- Being tested
- invasive coronary angiography, Functional testing by fractional flow reserve measurement
- Keywords
- fractional flow reserve, multivessel coronary artery disease, angiography
- Medical subject headings
- Angina, Stable, Angina, Unstable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
invasive coronary angiographyProcedure or surgery
Functional testing by fractional flow reserve measurementProcedure or surgery
Functional testing by fractional flow reserve measurement
| Study group | Role | What they receive |
|---|---|---|
| FRACTIONAL FLOW RESERVE | Other | Patients will have FFR measured in each diseased vessel identified by the coronary angiographic evaluation. Intra-coronary adenosine (at least 100 micrograms performed 2 times) OR intravenous adenosine (at a dose of 140µg/kg/min during at least 4 minutes) will be administered prior to FFR assessment.
Revascularization strategy will be based upon FFR findings and revascularization either by coronary stenting or CABG will only be performed on target lesions with FFR≤0.8. Receives: Procedure: invasive coronary angiography |
| ANGIOGRAPHY | Other | Patients undergo an angiography. Based on angiographic evaluation, the physicians define the revascularization strategy. Receives: Procedure: Functional testing by fractional flow reserve measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
composite endpoint that includes the rate of major cardiovascular events defined as a composite of death from any cause, myocardial infarction, any hospitalization leading to additional coronary revascularization, stroke.
The effect of therapeutic strategy will be assessed by the reduction of the incidence of major cardiovascular events in the group "angiography with FFR testing" in comparison to the group "angiography alone". Patients will be prospectively and clinically followed during the duration of the study and all major cardiovascular events will be documented and reported in the electronic case report form.
Measured: 1 year.
Bypass graft patency assessed in all CABG patients at one year by coronary multidetector computed tomography .
Measured: 1 year
Secondary outcomes (8)
Major cardiovascular events in all patients, in diabetic patients, by revascularization strategy (angioplasty, coronary artery bypass graft surgery, medical optimal treatment).
Measured: 1 year
The effect of our therapeutic strategy will be assessed upon each category of cardiovascular event individually.
Measured: 1 year
Major cardiovascular events in all patients.
Measured: 2 years, 3 years, 4 years and 5 years
Stent thrombosis.
Measured: 1 year
Bleeding events.
Measured: 1 year
Patient's quality of life
We will use the European Quality of Life-5 Dimensions instrument.
Measured: 1 year
Cost-effectiveness of each therapeutic strategy
NACost-effectiveness of each therapeutic strategy will be assessed by the evaluation of medical costs linked to the pathology (hospitalizations, consultations, and external medical costs (biology, radiology, medications) and compared in the 2 groups during the first 12 months of follow up.
Measured: 1 year
Bypass graft patency assessed in all CABG patients at one year by coronary multidetector computed tomography .
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2013 (estimated)
- Study start27 May 2013
- Primary completion10 Jun 2017
- Study completion10 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multivessel Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 941 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01881555
- Sponsor's protocol ID
- 2012.725
- Other IDs
- Numéro ID RCB : 2012-A01195-38
- Acronym
- FUTURE
- Status last verified
- Jun 2018
- First submitted
- 29 May 2013
- Last updated
- 26 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rioufol G, Derimay F, Roubille F, Perret T, Motreff P, Angoulvant D, Cottin Y, Meunier L, Cetran L, Cayla G, Harbaoui B, Wiedemann JY, Van Belle E, Pouillot C, Noirclerc N, Morelle JF, Soto FX, Caussin C, Bertrand B, Lefevre T, Dupouy P, Lesault PF, Albert F, Barthelemy O, Koning R, Leborgne L, Barnay P, Chapon P, Armero S, Lafont A, Piot C, Amaz C, Vaz B, Benyahya L, Varillon Y, Ovize M, Mewton N, Finet G; FUTURE Trial Investigators. Fractional Flow Reserve to Guide Treatment of Patients With Multivessel Coronary Artery Disease. J Am Coll Cardiol. 2021 Nov 9;78(19):1875-1885. doi: 10.1016/j.jacc.2021.08.061.
PubMed 34736563
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FUnctional Testing Underlying Coronary REvascularisation.
- ClinicalTrials.gov ID
- NCT01881555
- Acronym / sponsor ID
- FUTURE / 2012.725
- Conditions
- Multivessel Coronary Artery Disease, Vessel Disease, Stable Angina, Unstable Angina or Stabilized Non-ST Elevated Myocardial Infarction, Patients With ST-elevated Myocardial Infarction, Revascularization of Culprit Coronary Artery
- Keywords
- fractional flow reserve, multivessel coronary artery disease, angiography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 941 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 27 May 2013
- Primary completion
- 10 Jun 2017 (actual)
- Study completion
- 10 Jun 2017 (actual)
- First posted
- 19 Jun 2013 (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 objective of this trial is to compare the clinical outcomes and cost-effectiveness of 2 therapeutic strategies, one based on coronary angiography guidance and the other based on coronary angiography with fractional flow reserve (FFR) in multivessel coronary artery disease patients.
The trial is a prospective, multicenter, French, randomized clinical trial including men and women ≥ 18 years presenting with significant multivessel disease defined by coronary angiography as coronary narrowing > 50% diameter stenosis in at least 2 major epicardic vessels. The patients who give their informed consent will be randomly assigned to a therapeutic strategy based upon coronary angiography or angiography with FFR testing. In the FFR group, a significant coronary stenosis will be defined by a FFR ≤ 0.8. Based upon this multivessel evaluation (angiography or FFR), the investigator will choose the best therapeutic strategy to his discretion (medical optimal treatment, coronary stenting, coronary artery bypass graft surgery). The aim of revascularization procedures will be to obtain complete revascularization. In the FFR group, only stenosis with FFR≤0.8 will be treated.
The primary end point of the trial is a composite of major cardiovascular events including death from any cause, myocardial infarction, any hospitalization for coronary revascularization performed in addition to initial treatment and stroke at 1 year of follow-up.
Secondary end points will include adverse events, individual major cardiovascular events, stent thrombosis, bleeding events, occlusion of coronary artery bypass graft, patient's quality of life and cost-effectiveness and 30-day, 6 month, 2-year and 5-year outcomes.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FRACTIONAL FLOW RESERVE | Other | Procedure: invasive coronary angiographyPatients will have FFR measured in each diseased vessel identified by the coronary angiographic evaluation. Intra-coronary adenosine (at least 100 micrograms performed 2 times) OR intravenous adenosine (at a dose of 140µg/kg/min during at least 4 minutes) will be administered prior to FFR assessment. Revascularization strategy will be based upon FFR findings and revascularization either by coronary stenting or CABG will only be performed on target lesions with FFR≤0.8. |
| ANGIOGRAPHY | Other | Procedure: Functional testing by fractional flow reserve measurementPatients undergo an angiography. Based on angiographic evaluation, the physicians define the revascularization strategy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- age > 18
- referred to the cardiologist for one of the following medical condition :
- Patient willing and able to provide informed, written consent
- Patient not under legal protection
- Patient benefiting from the French Health Insurance
Key exclusion criteria (4 listed)
- Pregnancy, childbearing, absence of effective contraception
- Previous coronary bypass surgery
- Planned associated valvular surgery
- Life expectancy < 2 years
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 |
|---|---|---|
| invasive coronary angiography | Procedure or surgery | FRACTIONAL FLOW RESERVE |
| Functional testing by fractional flow reserve measurementFunctional testing by fractional flow reserve measurement | Procedure or surgery | ANGIOGRAPHY |
Primary outcome
composite endpoint that includes the rate of major cardiovascular events defined as a composite of death from any cause, myocardial infarction, any hospitalization leading to additional coronary revascularization, stroke.
Time frame: 1 year.
The effect of therapeutic strategy will be assessed by the reduction of the incidence of major cardiovascular events in the group "angiography with FFR testing" in comparison to the group "angiography alone". Patients will be prospectively and clinically followed during the duration of the study and all major cardiovascular events will be documented and reported in the electronic case report form.
Bypass graft patency assessed in all CABG patients at one year by coronary multidetector computed tomography .
Time frame: 1 year
8 secondary outcomes
Major cardiovascular events in all patients, in diabetic patients, by revascularization strategy (angioplasty, coronary artery bypass graft surgery, medical optimal treatment).
Time frame: 1 year
The effect of our therapeutic strategy will be assessed upon each category of cardiovascular event individually.
Time frame: 1 year
Major cardiovascular events in all patients.
Time frame: 2 years, 3 years, 4 years and 5 years
Stent thrombosis.
Time frame: 1 year
Bleeding events.
Time frame: 1 year
Patient's quality of life
Time frame: 1 year
Cost-effectiveness of each therapeutic strategy
Time frame: 1 year
Bypass graft patency assessed in all CABG patients at one year by coronary multidetector computed tomography .
Time frame: 1 year
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 26 Sep 2025.
- Results publication: PubMed 34736563Rioufol G, Derimay F, Roubille F, Perret T, Motreff P, Angoulvant D, Cottin Y, Meunier L, Cetran L, Cayla G, Harbaoui B, Wiedemann JY, Van Belle E, Pouillot C, Noirclerc N, Morelle JF, Soto FX, Caussin C, Bertrand B, Lefevre T, Dupouy P, Lesault PF, Albert F, Barthelemy O, Koning R, Leborgne L, Barnay P, Chapon P, Armero S, Lafont A, Piot C, Amaz C, Vaz B, Benyahya L, Varillon Y, Ovize M, Mewton N, Finet G; FUTURE Trial Investigators. Fractional Flow Reserve to Guide Treatment of Patients With Multivessel Coronary Artery Disease. J Am Coll Cardiol. 2021 Nov 9;78(19):1875-1885. doi: 10.1016/j.jacc.2021.08.061.
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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?
A study testing invasive coronary angiography and Functional testing by fractional flow reserve measurement in people with Multivessel Coronary Artery Disease and Vessel Disease, run by Hospices Civils de Lyon at 1 site in France.
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 10 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 26 Sep 2025. 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 France. 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?
composite endpoint that includes the rate of major cardiovascular events defined as a composite of death from any cause, myocardial infarction, any hospitalization leading to additional coronary revascularization, stroke. (time frame: 1 year.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01881555, which also lists 1 linked publication.
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 26 Sep 2025.