Functional Testing Underlying Coronary Revascularisation

NCT ID: NCT01881555

Last Updated: 2025-09-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 941 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-27
• Study Completion Date: 2017-06-10

Brief 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.

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

FRACTIONAL FLOW RESERVE

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.

Group Type: OTHER

invasive coronary angiography

Intervention Type: PROCEDURE

ANGIOGRAPHY

Patients undergo an angiography. Based on angiographic evaluation, the physicians define the revascularization strategy.

Group Type: OTHER

Functional testing by fractional flow reserve measurement

Intervention Type: PROCEDURE

Functional testing by fractional flow reserve measurement

Interventions

invasive coronary angiography

Intervention Type: PROCEDURE

Functional testing by fractional flow reserve measurement

Functional testing by fractional flow reserve measurement

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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.
• 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

Exclusion Criteria

• Pregnancy, childbearing, absence of effective contraception
• Previous coronary bypass surgery
• Planned associated valvular surgery
• Life expectancy < 2 years

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

HOSPICES

Lyon, , France

Countries

France

References

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.

Reference Type: RESULT

PMID: 34736563 (View on PubMed)

Other Identifiers

Numéro ID RCB : 2012-A01195-38

Identifier Type: OTHER

Identifier Source: secondary_id

2012.725

Identifier Type: -

Identifier Source: org_study_id