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Fractional FLow Reserve And IVUS for Clinical OUtcomes in Patients With InteRmediate Stenosis (FLAVOUR)

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: NCT02673424
Recruitment Status : Active, not recruiting
First Posted : February 3, 2016
Last Update Posted : June 4, 2020
Sponsor:
Collaborators:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Samsung Medical Center, Sungkyunkwan University School of Medicine
Ulsan University Hospital
Keimyung University Dongsan Medical Center
Inje University
KangWon National University Hospital
Ajou University School of Medicine
Information provided by (Responsible Party):
Bon-Kwon Koo, Seoul National University Hospital

Brief Summary:
To compare the safety and efficacy of FFR (fractional flow reserve)-guided percutaneous coronary intervention (PCI) strategy with IVUS (intravascular ultrasound [IVUS])-guided PCI in patients with intermediate coronary stenosis.

Condition or disease Intervention/treatment Phase
Stable Angina Procedure: FFR-guided stenting Procedure: IVUS-guided stenting Not Applicable

Detailed Description:
  1. Study overview This study is a prospective, open-label, randomized, multicenter trial to test the safety and efficacy of physiology- or imaging-guided PCI in patients with intermediate coronary stenosis.

    The primary hypothesis is that FFR-guided strategy will show non-inferior rate of patients-oriented composite outcomes (POCO) at 24 months after randomization, compared with IVUS-guided strategy in patients with intermediate coronary stenosis.

  2. Study population and sample size calculation

    Sample Size Calculation Based on the event rates of previous trials, investigators predicted the rates of POCO at 24 months after PCI will be 10% in the FFR-guided arm, and 12% in the IVUS-guided arm.

    • Primary endpoint: patient-oriented composite outcome (a composite of all-cause death, MI, any repeat revascularization) at 24 months after PCI
    • Design: non-inferiority , delta = 2.5%
    • Sampling ratio: FFR-guided strategy : IVUS-guided strategy = 1:1
    • Type I error (α): One-sided 5%
    • Accrual time : 2 years
    • Total time : 4 years (accrual 2 year + follow-up 2 years)
    • Assumption: POCO 10.0% vs. 12.0% in FFR or IVUS-guided strategy, respectively
    • Statistical power (1- β): 90%
    • Primary statistical method : Kaplan-Meier survival analysis with log-rank test
    • Potential withdrawal rates : total 2%
    • Stratification in Randomization: Presence of Diabetes Mellitus (600 patients (35%) will be Diabetic patients, with 300 patients in each group)

    Based on the above assumption, 1,700 patients (850 patients in each group) will be enrolled in this study with consideration of withdrawal rates.

  3. Research Materials and Indication for Revascularization For the FFR-guided strategy arm, a pressure-sensor wire system will be used and the criterion for revascularization is FFR ≤ 0.80. Hyperemia will be induced by intravenous infusion of adenosine (140ug/kg/min). For the IVUS-guided strategy arm, the criterion for revascularization is MLA ≤ 3mm2 or [3mm2 < MLA ≤ 4mm2 and plaque burden > 70%].
  4. Funding This is an investigator-initiated study with grant support from Boston Scientific. Other than financial sponsorship, the company has no role in protocol development or the implementation, management, data collection, and analysis of this study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Clinical Outcomes Between Imaging and Physiology-guided Intervention Strategy in Patients With Intermediate Stenosis: Fractional FLow Reserve And IVUS for Clinical OUtcomes in Patients With InteRmediate Stenosis (FLAVOUR)
Study Start Date : June 2016
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : January 2022

Arm Intervention/treatment
Active Comparator: FFR-guided stenting
Percutaneous coronaryintervention using drug-eluting stent(s) will be performed by FFR-guided strategy.
Procedure: FFR-guided stenting

The percutaneous coronaryintervention using drug-eluting stent will be indicated according to following criteria in the FFR-guided strategy arm

* Criteria for revascularization: The FFR ≤ 0.80 will be targeted for PCI


Active Comparator: IVUS-guided stenting
Percutaneous coronaryintervention using drug-eluting stent(s) will be performed by IVUS-guided strategy.
Procedure: IVUS-guided stenting

The percutaneous coronaryintervention using drug-eluting stent will be indicated according to following criteria in the IVUS-guided strategy arm

* Criteria for revascularization: Minimum lumen area (MLA) ≤ 3mm2 or (MLA ≤ 4mm2 AND Plaque burden >70%)





Primary Outcome Measures :
  1. Patient-oriented composite outcome [ Time Frame: 24 months ]
    a composite of all death, myocardial infarction (MI) or any revascularization


Secondary Outcome Measures :
  1. Patient-oriented composite outcome [ Time Frame: 12 months ]
    a composite of all death, myocardial infarction (MI) or any

  2. Stent-oriented composite endpoint [ Time Frame: 12 months ]
    a composite of cardiac death, target-vessel MI, or target lesion revascularization

  3. Stent-oriented composite endpoint [ Time Frame: 24 months ]
    a composite of cardiac death, target-vessel MI, or target lesion revascularization

  4. Cost-effectiveness analysis [ Time Frame: 24 months ]
    medical expenses of treatment and follow-up. Cost estimates utilize micro-costing, the total cost by identifying the utilization of medical resources used, and macro-costing, medical expenses resulting from clinical events from health insurance data.

  5. All-cause death [ Time Frame: 24 months ]
    death from any cause

  6. Cardiac death [ Time Frame: 24 months ]
    death from cardiaccause

  7. Target-vessel and all-cause nonfatal myocardial infarction without per-procedural myocardial infarction [ Time Frame: 24 months ]
    Myocardial infarction during 24 months follow-up without periprocedural myocardial infarction

  8. Target-vessel and all-cause nonfatal myocardial infarction with per-procedural myocardial infarction [ Time Frame: 24 months ]
    Myocardial infarction during 24 months follow-up with periprocedural myocardial infarction

  9. Peri-procedural MI using referred definitions [ Time Frame: At discharge (1 week after index procedure) ]
    Number of participants with peri-procedural myocardial infarction after PCI

  10. Target vessel/lesion revascularization [ Time Frame: 24 months ]
    Number of participants and vessels/lesions with ischemia-driven or any reavascularizations at target vessel/lesion

  11. Non-target vessel/lesion revascularization [ Time Frame: 24 months ]
    Number of participants and vessels/lesions with ischemia-driven or any reavascularizations at non-target vessel/lesion.

  12. Any revascularization [ Time Frame: 24 months ]
    Number of participants and vessels/lesions with ischemia-driven or any revascularizations at any vessel/lesion

  13. Academic Research Consortium defined - Stent thrombosis [ Time Frame: 24 months ]
    Number of participants with definite/probable/possible stent thrombosis

  14. Stroke [ Time Frame: 24 months ]
    Number of participants with ischemic or hemorrhagic stroke

  15. Acute success of procedure [ Time Frame: immediately after the intervention ]
    Device-related, lesion-related and procedure-related success of index procedure (residual diameter stenosis<50% and thrombolysis in myocardial infarction flow 3)

  16. Angina severity measured with Seattle Angina Questionnaires [ Time Frame: 12 months ]
    Seattle Angina Questionnaires (physical limitation and angina frequency were classified as minimal: 75-100, mild: 50-74, moderate: 25-49, severe: 0-24)

  17. Angina severity measured with Seattle Angina Questionnaires [ Time Frame: 24 months ]
    Seattle Angina Questionnaires (physical limitation and angina frequency were classified as minimal: 75-100, mild: 50-74, moderate: 25-49, severe: 0-24)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  1. Inclusion Criteria

    • 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 and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure.

      • 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 for further evaluation ⑤ Target vessel size > 2.5mm

        • Target lesions located at the proximal to mid part of coronary artery
  2. Exclusion Criteria

    • Known hypersensitivity or contraindication to any of the following medications: Heparin, Aspirin, Clopidogrel, Prasugrel, Ticagrelor, Adenosine.

      • Active pathologic bleeding

        • Gastrointestinal or genitourinary major bleeding within the prior 3 months.

          • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02673424


Locations
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China
The Second Affiliated Hospital, School of Medicine, Zhejiang University
Zhejiang, China
Korea, Republic of
Keimyung University Dongsan Medical Center
Daegu, Korea, Republic of
Inje University Ilsan Paik Hospital
Goyang, Korea, Republic of
Samsung Medical Center, Sungkyunkwan University School of Medicine
Seoul, Korea, Republic of, 135-710
Seoul National University Hospital, Seoul, Korea
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
Second Affiliated Hospital, School of Medicine, Zhejiang University
Samsung Medical Center, Sungkyunkwan University School of Medicine
Ulsan University Hospital
Keimyung University Dongsan Medical Center
Inje University
KangWon National University Hospital
Ajou University School of Medicine
Investigators
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Principal Investigator: Bon-Kwon Koo, MD, PhD Seoul National University Hospital
Principal Investigator: Seung-Jea Tahk, MD, PhD Ajou University School of Medicine
Principal Investigator: JianAn Wang, MD, PhD Second Affiliated Hospital, School of Medicine, Zhejiang University
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Responsible Party: Bon-Kwon Koo, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02673424    
First Posted: February 3, 2016    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The deidentified data will be shared after publication of first manuscript
Supporting Materials: Study Protocol
Time Frame: Data will be available within 12 months of study completion.
Access Criteria: Data access requests will be reviewed by an external Independent Review Panel. Requestors will be required to sign a Data Access Agreement
Additional relevant MeSH terms:
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Angina, Stable
Angina Pectoris
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Neurologic Manifestations