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Fractional FLow Reserve And IVUS for Clinical OUtcomes in Patients with InteRmediate Stenosis

Status Approved

  • First Submitted Date

    2018/06/12

  • Registered Date

    2018/08/17

  • Last Updated Date

    2018/07/06

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0003100
    Unique Protocol ID 1602-134-744
    Public/Brief Title Fractional FLow Reserve And IVUS for Clinical OUtcomes in Patients with InteRmediate Stenosis
    Scientific Title Fractional FLow Reserve And IVUS for Clinical OUtcomes in Patients with InteRmediate Stenosis
    Acronym FLAVOUR
    MFDS Regulated Study No
    IND/IDE Protocol No
    Registered at Other Registry No
    Healthcare Benefit Approval Status Submitted pending
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number H-1602-134-744
    Approval Date 2016-05-03
    Institutional Review Board Name Seoul National University Hospital Institutional Review Board
    Institutional Review Board Address HRPP Office, Advanced Treatment and Development Center, 101 Daehangno, Jongno-Gu, Seoul, 110-744, Korea
    Institutional Review Board Telephone 02-2072-0694
    Data Monitoring Committee
  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name Bonkwon Koo
    Title Professor
    Telephone +82-2-2072-2677
    Affiliation Seoul National University Hospital
    Address 101 Daehangno, Jongno-Gu, Seoul
    Contact Person for Public Queries
    Name Jinlong Zhang
    Title Researcher
    Telephone +82-2-2072-3757
    Affiliation Seoul National University Hospital
    Address 101 Daehangno, Jongno-Gu, Seoul
    Contact Person for Updating Information
    Name Sunhwa LEE
    Title Clinical Research Co
    Telephone +82-2-2072-3757
    Affiliation Seoul National University Hospital
    Address 101 Daehangno, Jongno-Gu, Seoul
  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Multi-center Number of center : 8 - Multi-national}
    Overall Recruitment Status Recruiting
    Date of First Enrollment 2016-05-03 Actual
    Target Number of Participant 1700
    Primary Completion Date 2019-05-31 , Anticipated
    Study Completion Date 2021-06-30 , Anticipated
    Recruitment Status by Participating Study Site 1
    Name of Study Samsung Medical Center
    Recruitment Status Recruiting
    Date of First Enrollment 2016-10-26 ,
    Recruitment Status by Participating Study Site 2
    Name of Study Ajou University Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2017-01-20 ,
    Recruitment Status by Participating Study Site 3
    Name of Study Keimyung University Dongsan Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2016-07-14 ,
    Recruitment Status by Participating Study Site 4
    Name of Study Inje University Ilsan Paik Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2017-07-11 ,
    Recruitment Status by Participating Study Site 5
    Name of Study Kangwon National University Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2017-12-14 ,
    Recruitment Status by Participating Study Site 6
    Name of Study Yonsei University, Wonju Severance Christian Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2017-12-18 ,
    Recruitment Status by Participating Study Site 7
    Name of Study Kyung Hee University Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2018-04-16 ,
    Recruitment Status by Participating Study Site 8
    Name of Study Seoul National University Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2016-05-03 ,
  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Boston Scientific Korea
    Organization Type Others
    Project ID
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Seoul National University Hospital
    Organization Type Medical Institute
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    1.Objectives :To compare the safety and efficacy of physiology (fractional flow reserve [FFR])-guided percutaneous coronary intervention (PCI) strategy with imaging (intravascular ultrasound [IVUS])-guided PCI strategy in patients with intermediate coronary stenosis
    2.Background
    Percutaneous coronary intervention (PCI) is the current standard treatment for coronary artery diseases. Especially, after the adoption of drug-eluting stents (DES), restenosis and revascularization has significantly decreased. However, due to the increased CAD population and the complexity of lesions treated with PCI, adverse effects after treatment is still a major issue. Therefore, there has been many effort to improve the outcome of PCI, where fractional flow reserve (FFR) and intravascular ultrasound (IVUS) are two strategies that are widely used.
    First, FFR-guided PCI is a method to measure the coronary blood flow, and physiologically interpret the stenotic lesion. FFR-guided PCI strategy for coronary artery disease has proved its benefit over angiography-guided PCI or medical treatment by previous randomized clinical trials.
    Second, IVUS-guided PCI strategy is a method that can provide information about the lesion and PCI appropriateness.Recent clinical studies and meta-analysis also showed that IVUS-guided PCI strategy could also reduce the incidence of major clinical events after drug-eluting stents implantation. Also, a recent trial has shown that IVUS-guided PCI strategy can reduce adverse effects up to 50%.
    However, there has been no randomized study to compare the outcomes of FFR-guided vs. IVUS-guided PCI in patients of intermediate stenosis. The FFR-guided PCI have been known to reduce the number of treated lesions, used stents, and peri-procedural myocardial infarction (MI) with better stratification of lesions which could be significantly benefit by the revascularization. Although previous study showed that FFR-guided PCI strategy reduced the number of intervention compared with IVUS-guided strategy with comparable rates of major adverse cardiovascular events, small number of patients and non-randomized design of the study was the major limitations. In this regards, the randomized comparison between physiology (FFR)-guided strategy and imaging (IVUS)-guided PCI will provide valuable insights to enhance the patient’s clinical outcomes with fewer number of intervention. The Fractional FLow Reserve And IVUS for Clinical OUtcomes in Patients with InteRmediate Stenosis (FLAVOUR) is a randomized controlled prospective multi-center trial. This study aims to compare safety and efficacy of physiology (FFR)-guided PCI strategy and imaging (IVUS)-guided PCI strategy in patients with intermediate coronary stenosis.
    3.Hypothesis
    The FFR-guided strategy for PCI with a drug-eluting stent (DES) will show significantly lower rates of patients-oriented composite outcomes at 24 months after randomization, compared with IVUS-guided strategy for PCI with a DES in patients with intermediate coronary stenosis. 
    4.Study design
    Prospective, open-label, randomized, multicenter trial to test the safety and efficacy of physiology- or imaging-guided PCI in patients with intermediate coronary stenosis.
  • 8. Study Design

    Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
    Study Type Interventional Study
    Study Purpose
    Diagnosis
    Phase Phase4
    Intervention Model Parallel  
    Blinding/Masking Open
    Allocation RCT
    Intervention Type Medical Device  
    Intervention Description
    FFR-guided strategy arm:Criteria for revascularization: The FFR ≤ 0.80 will be targeted for PCI.
    IVUS-guided strategy arm:Criteria for revascularization: Minimum lumen area (MLA) ≤ 3mm2 or (MLA ≤ 4mm2 
    AND Plaque burden >70%)
    Number of Arms 2
    Arm 1

    Arm Label

    FFR-guided strategy arm

    Target Number of Participant

    850

    Arm Type

    Active comparator

    Arm Description

    FFR-guided strategy arm
    :The FFR guided strategy groups are defined as the patients who will be evaluated by FFR  to decide the revascularization with a DES for the intermediate coronary stenosis in major coronary artery.
    Pressure-Sensor Wire System
    Criteria for revascularization: The FFR ≤ 0.80 will be targeted for PCI.
    Arm 2

    Arm Label

    IVUS-guided strategy arm

    Target Number of Participant

    850

    Arm Type

    Active comparator

    Arm Description

    IVUS-guided strategy arm
    :IVUS guided strategy groups are defined as the patients who will be evaluated by  IVUS to decide the revascularization with a DES for the intermediate coronary stenosis in major coronary artery.
    iLabTM ultrasound imaging system (Boston Scientific)
    Criteria for revascularization: Minimum lumen area (MLA) ≤ 3mm2 or (MLA ≤ 4mm2 
    AND Plaque burden >70%)
  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s) * (I00-I99)Diseases of the circulatory system 
       (I25.1)Atherosclerotic heart disease 
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    19Year~No Limit

    Description

    ①	Subject must be ≥ 19 years
    ②	Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of receiving invasive physiologic or imaging evaluation and PCI with a drug-eluting stent (DES) and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure.
    ③	Patients suspected with ischemic heart disease
    ④	Patients with intermediate degree of stenosis (40-70% stenosis by visual estimation) eligible for stent implantation who need FFR or IVUS clinically for further evaluation  
    ⑤	Target vessel size > 2.5mm in visual estimation
    ⑥	Target vessels are limited to proximal to mid LAD, proximal to distal LCX, and RCA proximal to the PL-PDA bifurcation
    Exclusion Criteria
    ①	The patient has a known hypersensitivity or contraindication to any of the following medications: Heparin, Aspirin, Clopidogrel, Prasugrel, Ticagrelor, Contrast media (Patients with documented sensitivity to contrast media which can be effectively premedicated with steroids and diphenhydramine [e.g. rash] may be enrolled.)
    ②	Patients with active pathologic bleeding
    ③	Gastrointestinal or genitourinary major bleeding within the prior 3 months.
    ④	History of bleeding diathesis, known coagulopathy (including heparin-induced thrombocytopenia)
    ⑤	Non-cardiac co-morbid conditions with life expectancy < 2 years
    ⑥	Target lesion located in coronary arterial bypass graft
    ⑦	Target lesion located in the left main coronary artery
    Healthy Volunteers No
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome /Safety/Efficacy
    Primary Outcome(s) 1
    Outcome
    Patient-oriented composite outcome (POCO), defined as a composite of all death, myocardial infarction (MI) or any repeat revascularization at 24 months after randomization according to the ARC consensus
    Timepoint
    24 months after randomization
    Secondary Outcome(s) 1
    Outcome
    POCO at 12months after randomization according to the ARC consensus
    Timepoint
    12months after randomization
    Secondary Outcome(s) 2
    Outcome
    Stent-oriented composite endpoint (a composite of cardiac death, target-vessel MI, or target lesion revascularization)
    Timepoint
    24 months after randomization
    Secondary Outcome(s) 3
    Outcome
    All-cause and cardiac death
    Timepoint
    24 months after randomization
    Secondary Outcome(s) 4
    Outcome
    Target-vessel and all-cause nonfatal MI without peri-procedural MI
    Timepoint
    24 months after randomization
    Secondary Outcome(s) 5
    Outcome
    Target-vessel and all-cause nonfatal MI with peri-procedural MI
    Timepoint
    24 months after randomization
    Secondary Outcome(s) 6
    Outcome
    arget vessel/lesion revascularization (ischemia-driven or all)
    Timepoint
    24 months after randomization
    Secondary Outcome(s) 7
    Outcome
    Non-target vessel/lesion revascularization (ischemia-driven or all)
    Timepoint
    24 months after randomization
    Secondary Outcome(s) 8
    Outcome
    Any revascularization (ischemia-driven or all)
    Timepoint
    24 months after randomization
    Secondary Outcome(s) 9
    Outcome
    Stent thrombosis (definite/probable/possible)
    Timepoint
    24 months after randomization
    Secondary Outcome(s) 10
    Outcome
    Stroke (ischemic and hemorrhagic)
    Timepoint
    24 months after randomization
    Secondary Outcome(s) 11
    Outcome
    Acute success of procedure (device, lesion and procedure)
    Timepoint
    24 months after randomization
    Secondary Outcome(s) 12
    Outcome
    Angina severity measured with Seattle Angina Questionnaires
    Timepoint
    12-month and 24-month after randomization
  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered No
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement Not provided at time of Registration
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