An interventional study of invasive coronary angiography and Functional testing by fractional flow reserve measurement in Multivessel Coronary Artery Disease, Vessel Disease and Stable Angina, sponsored by Hospices Civils de Lyon. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-26.
Sponsored by Hospices Civils de Lyon · Not applicable, Interventional, and Diagnostic
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.
345 studies on the registry are indexed under Angina, Stable; 57 are open to participants now.
This study's enrollment of 941 is above the median of 150 across 236 interventional studies indexed under Angina, Stable.
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referred to the cardiologist for one of the following medical condition :
Exclusion Criteria:
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.
Procedure: invasive coronary angiography
Patients undergo an angiography. Based on angiographic evaluation, the physicians define the revascularization strategy.
Procedure: Functional testing by fractional flow reserve measurement
Functional testing by fractional flow reserve measurement
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.
Time frame: 1 year.
Bypass graft patency assessed in all CABG patients at one year by coronary multidetector computed tomography .
Time frame: 1 year
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
We will use the European Quality of Life-5 Dimensions instrument.
Time frame: 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.
Time frame: 1 year
Bypass graft patency assessed in all CABG patients at one year by coronary multidetector computed tomography .
Time frame: 1 year
This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
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Hospices Civils de Lyon