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Functional Testing Underlying Coronary Revascularisation (FUTURE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01881555
Recruitment Status : Completed
First Posted : June 19, 2013
Last Update Posted : June 28, 2018
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Tracking Information
First Submitted Date  ICMJE May 29, 2013
First Posted Date  ICMJE June 19, 2013
Last Update Posted Date June 28, 2018
Study Start Date  ICMJE May 27, 2013
Actual Primary Completion Date June 10, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 18, 2013)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 18, 2013)
  • 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 ]
    We will use the European Quality of Life-5 Dimensions instrument.
  • Cost-effectiveness of each therapeutic strategy [ Time Frame: 1 year ]
    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.
  • Bypass graft patency assessed in all CABG patients at one year by coronary multidetector computed tomography . [ Time Frame: 1 year ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Functional Testing Underlying Coronary Revascularisation
Official Title  ICMJE FUnctional Testing Underlying Coronary REvascularisation.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • 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
Intervention  ICMJE
  • Procedure: invasive coronary angiography
  • Procedure: Functional testing by fractional flow reserve measurement
    Functional testing by fractional flow reserve measurement
Study Arms  ICMJE
  • 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.

    Intervention: Procedure: invasive coronary angiography
  • ANGIOGRAPHY
    Patients undergo an angiography. Based on angiographic evaluation, the physicians define the revascularization strategy.
    Intervention: Procedure: Functional testing by fractional flow reserve measurement
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 4, 2016)		 941
Original Estimated Enrollment  ICMJE
 (submitted: June 18, 2013)		 1728
Actual Study Completion Date  ICMJE June 10, 2017
Actual Primary Completion Date June 10, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01881555
Other Study ID Numbers  ICMJE 2012.725
Numéro ID RCB : 2012-A01195-38 ( Other Identifier: ANSM )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Hospices Civils de Lyon
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Hospices Civils de Lyon
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Hospices Civils de Lyon
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP