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Stable AnginaFLAVOURNCT02673424

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

A study testing FFR-guided stenting and IVUS-guided stenting in people with Stable Angina, run by Seoul National University Hospital at 5 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Stable Angina
What is being tested?
FFR-guided stenting and IVUS-guided stenting
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,700 participants
Where
5 sitesin 2 countries
Study dates
Jun 2016to Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult
  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
  1. 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

Trial locations and contacts

5 sites in 2 countries.

5 sites in 2 countries

South Korea4 sites

  • Keimyung University Dongsan Medical Center

    Daegu

  • Inje University Ilsan Paik Hospital

    Goyang

  • Samsung Medical Center, Sungkyunkwan University School of Medicine

    Seoul, 135-710

  • Seoul National University Hospital, Seoul, Korea

    Seoul

Other trials in South Korea

China1 site

  • The Second Affiliated Hospital, School of Medicine, Zhejiang University

    Zhejiang

Other trials in China

About this study

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)

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.

Read the 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.
  1. 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%].
  2. 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.
  3. Extended Outcome Follow-Up Following the 2-year follow-up period, clinical outcomes will also be collected until September 30, 2024, to assess the long-term outcomes of each treatment group.
Conditions
Stable Angina
Being tested
FFR-guided stenting, IVUS-guided stenting
Medical subject headings
Angina, Stable

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FFR-guided stentingProcedure or surgery

    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

  • IVUS-guided stentingProcedure or surgery

    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%)
Study groups in NCT02673424
Study groupRoleWhat they receive
FFR-guided stentingActive comparatorPercutaneous coronaryintervention using drug-eluting stent(s) will be performed by FFR-guided strategy.
Receives: Procedure: FFR-guided stenting
IVUS-guided stentingActive comparatorPercutaneous coronaryintervention using drug-eluting stent(s) will be performed by IVUS-guided strategy.
Receives: Procedure: IVUS-guided stenting

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Patient-oriented composite outcome

    a composite of all death, myocardial infarction (MI) or any revascularization

    Measured: 24 months

  2. Long-term patient-oriented composite outcome

    A composite of all death, myocardial infarction [MI, including peri-procedural MI] or any revascularization during the extended follow-up period after randomization according to the ARC consensus.

    Measured: Up to 7 years

Secondary outcomes (39)

  1. Patient-oriented composite outcome

    a composite of all death, myocardial infarction (MI) or any

    Measured: 12 months

  2. Stent-oriented composite endpoint

    a composite of cardiac death, target-vessel MI, or target lesion revascularization

    Measured: 12 months

  3. Stent-oriented composite endpoint

    a composite of cardiac death, target-vessel MI, or target lesion revascularization

    Measured: 24 months

  4. Cost-effectiveness analysis

    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.

    Measured: 24 months

  5. All-cause death

    death from any cause

    Measured: 24 months

  6. Cardiac death

    death from cardiaccause

    Measured: 24 months

  7. Target-vessel and all-cause nonfatal myocardial infarction without per-procedural myocardial infarction

    Myocardial infarction during 24 months follow-up without periprocedural myocardial infarction

    Measured: 24 months

  8. Target-vessel and all-cause nonfatal myocardial infarction with per-procedural myocardial infarction

    Myocardial infarction during 24 months follow-up with periprocedural myocardial infarction

    Measured: 24 months

  9. Peri-procedural MI using referred definitions

    Number of participants with peri-procedural myocardial infarction after PCI

    Measured: At discharge (1 week after index procedure)

  10. Target vessel/lesion revascularization

    Number of participants and vessels/lesions with ischemia-driven or any reavascularizations at target vessel/lesion

    Measured: 24 months

  11. Non-target vessel/lesion revascularization

    Number of participants and vessels/lesions with ischemia-driven or any reavascularizations at non-target vessel/lesion.

    Measured: 24 months

  12. Any revascularization

    Number of participants and vessels/lesions with ischemia-driven or any revascularizations at any vessel/lesion

    Measured: 24 months

  13. Academic Research Consortium defined - Stent thrombosis

    Number of participants with definite/probable/possible stent thrombosis

    Measured: 24 months

  14. Stroke

    Number of participants with ischemic or hemorrhagic stroke

    Measured: 24 months

  15. Acute success of procedure

    Device-related, lesion-related and procedure-related success of index procedure (residual diameter stenosis<50% and thrombolysis in myocardial infarction flow 3)

    Measured: immediately after the intervention

  16. Angina severity measured with Seattle Angina Questionnaires

    Seattle Angina Questionnaires (physical limitation and angina frequency were classified as minimal: 75-100, mild: 50-74, moderate: 25-49, severe: 0-24)

    Measured: 12 months

  17. Angina severity measured with Seattle Angina Questionnaires

    Seattle Angina Questionnaires (physical limitation and angina frequency were classified as minimal: 75-100, mild: 50-74, moderate: 25-49, severe: 0-24)

    Measured: 24 months

  18. Long-term patient-oriented composite outcome in subgroups by use of anti-platelet agent and lipid-lowering agents

    A composite of all death, myocardial infarction [MI, including peri-procedural MI] or any revascularization during the extended follow-up period in subgroups stratified by use of anti-platelet agent and lipid-lowering agents

    Measured: Up to 7 years

  19. Long-term patient-oriented composite outcome in subgroups by lipid profiles

    Long-term patient-oriented composite outcome in subgroups stratified by changes in LDL-cholesterol, HDL-cholesterol, and triglyceride during the extended follow-up period

    Measured: Up to 7 years

  20. Long-term mortality

    All-cause and cardiac death during the extended follow-up period

    Measured: Up to 7 years

  21. Long-term myocardial infarction

    Myocardial infarction during the extended follow-up period

    Measured: Up to 7 years

  22. Long-term any revascularization

    Any revascularization during the extended follow-up period

    Measured: Up to 7 years

  23. Long-term target vessel failure

    Target vessel failure (cardiac death, target vessel MI, target vessel revascularization) during the extended follow-up period

    Measured: Up to 7 years

  24. Long-term target vessel myocardial infarction

    Target vessel myocardial infarction during the extended follow-up period

    Measured: Up to 7 years

  25. Long-term target vessel revascularization

    Target vessel revascularization during the extended follow-up period

    Measured: Up to 7 years

  26. Long-term target lesion revascularization

    Target lesion revascularization during the extended follow-up period

    Measured: Up to 7 years

  27. Long-term non-target lesion revascularization-target vessel revascularization

    Non-target lesion revascularization-target vessel revascularization during the extended follow-up period

    Measured: Up to 7 years

  28. Long-term stent thrombosis

    Stent thrombosis (definite/probable/possible) during the extended follow-up period

    Measured: Up to 7 years

  29. Long-term stroke

    Stroke (ischemic and hemorrhagic) during the extended follow-up period

    Measured: Up to 7 years

  30. Landmark analysis for patient-oriented composite outcome

    A 2 year landmark analysis of patient-oriented composite outcome and its individual outcome components

    Measured: Up to 7 years

  31. Long-term patient-oriented composite outcome in the medical treatment group

    Patient-oriented composite outcome and individual components of outcomes in the medical treatment group

    Measured: Up to 7 years

  32. Long-term patient-oriented composite outcome in the PCI group

    Patient-oriented composite outcome and individual components of outcomes in the PCI group

    Measured: Up to 7 years

  33. Long-term patient-oriented composite outcome according to PCI optimization

    Patient-oriented composite outcome and individual outcome components among patients in the PCI group, comparing those who received PCI optimization to those who did not.

    Measured: Up to 7 years

  34. Landmark analysis for target vessel failure

    A 2 year landmark analysis of target vessel failure and its individual outcome components

    Measured: Up to 7 years

  35. Long-term target vessel failure in the medical treatment group

    Target vessel failure and individual components of outcomes in the medical treatment group

    Measured: Up to 7 years

  36. Long-term target vessel failure in the PCI group

    Target vessel failure and individual components of outcomes in the PCI group

    Measured: Up to 7 years

  37. Long-term target vessel failure according to PCI optimization

    Target vessel failure and individual outcome components among patients in the PCI group, comparing those who received PCI optimization to those who did not.

    Measured: Up to 7 years

  38. Long-term target vessel failure according to IVUS-derived plaque characteristics

    Target vessel failure (cardiac death, target vessel MI, target vessel revascularization) during the extended follow-up period according to IVUS-derived plaque characteristics

    Measured: Up to 7 years

  39. Long-term target vessel failure according to QFR values

    Target vessel failure (cardiac death, target vessel MI, target vessel revascularization) during the extended follow-up period according to QFR values

    Measured: Up to 7 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Feb 2016 (estimated)
  2. Study startJun 2016
  3. Primary completionFeb 2025 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,700 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02673424
Sponsor's protocol ID
NCT02673424
Acronym
FLAVOUR
Status last verified
May 2020
First submitted
1 Feb 2016
Last updated
10 Feb 2025
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes: The deidentified data will be shared after publication of first manuscript

Publications

  • He W, Tang W, Zhang J, Wu X, Lu H, Xie Y, Chen X, Sun Y, Li C, Zhu L, Gao F, Dong L, Liu Y, Shen J, Ni C, Wang K, Chen Z, Chen H, Li S, Yang S, Kang J, Hwang D, Hahn JY, Nam CW, Doh JH, Lee BK, Kim W, Huang J, Jiang F, Zhou H, Chen P, Tang L, Jiang W, Ahn SG, Yoon MH, Kim U, Lee JM, Ki YJ, Shin ES, Tahk SJ, Koo BK, Jiang J, Hu X, Wang J. Impact of Renal Dysfunction on FFR- or IVUS-Guided PCI for Intermediate Coronary Stenosis. JACC Asia. 2026 Sep 17:S2772-3747(26)00704-0. doi: 10.1016/j.jacasi.2026.07.044. Online ahead of print.

    PubMed 42762209

  • Ding D, Zhang J, Wu P, Wang Z, Shi H, Yu W, Hu X, Kang J, Hahn JY, Nam CW, Doh JH, Lee BK, Kim W, Huang J, Jiang F, Zhou H, Chen P, Tang L, Jiang W, Chen X, He W, Ahn SG, Yoon MH, Kim U, Ki YJ, Shin ES, Tahk SJ, Pu J, Wijns W, Wang J, Koo BK, Tu S. Prognostic Value of Postpercutaneous Coronary Intervention Murray-Law-Based Quantitative Flow Ratio: Post Hoc Analysis From FLAVOUR Trial. JACC Asia. 2025 Jan 7;5(1):59-70. doi: 10.1016/j.jacasi.2024.10.019. eCollection 2025 Jan.

    PubMed 39886193

  • Hwang D, Kim HL, Ko J, Choi H, Jeong H, Jang SA, Hu X, Kang J, Zhang J, Jiang J, Hahn JY, Nam CW, Doh JH, Lee BK, Kim W, Huang J, Jiang F, Zhou H, Chen P, Tang L, Jiang W, Chen X, He W, Ahn SG, Kim U, Ki YJ, Shin ES, Kim HS, Tahk SJ, Wang J, Lee TJ, Koo BK; FLAVOUR Investigators. Cost-effectiveness of Fractional Flow Reserve Versus Intravascular Ultrasound to Guide Percutaneous Coronary Intervention: Results From the FLAVOUR Study. Korean Circ J. 2025 Jan;55(1):34-46. doi: 10.4070/kcj.2024.0156. Epub 2024 Oct 11.

    PubMed 39601394

  • Lee JH, Ahn SG, Jeon HS, Lee JW, Youn YJ, Zhang J, Hu X, Wang J, Lee JM, Hahn JY, Nam CW, Doh JH, Lee BK, Kim W, Huang J, Jiang F, Zhou H, Chen P, Tang L, Jiang W, Chen X, He W, Yoon MH, Tahk SJ, Kim U, Ki YJ, Shin ES, Hwang D, Kang J, Kim HS, Koo BK. Discordance Between Angiographic Assessment and Fractional Flow Reserve or Intravascular Ultrasound in Intermediate Coronary Lesions: A Post-hoc Analysis of the FLAVOUR Trial. Korean Circ J. 2024 Aug;54(8):485-496. doi: 10.4070/kcj.2024.0046. Epub 2024 Jun 10.

    PubMed 38956940

  • Lee JM, Kim H, Hong D, Hwang D, Zhang J, Hu X, Jiang J, Nam CW, Doh JH, Lee BK, Kim W, Huang J, Jiang F, Zhou H, Chen P, Tang L, Jiang W, Chen X, He W, Kang J, Ahn SG, Yoon MH, Kim U, Ki YJ, Shin ES, Choi KH, Park TK, Yang JH, Song YB, Choi SH, Gwon HC, Koo BK, Kim HS, Tahk SJ, Wang J, Hahn JY; FLAVOUR Investigators. Clinical Outcomes of Deferred Lesions by IVUS Versus FFR-Guided Treatment Decision. Circ Cardiovasc Interv. 2023 Dec;16(12):e013308. doi: 10.1161/CIRCINTERVENTIONS.123.013308. Epub 2023 Nov 29.

    PubMed 38018840

  • Koo BK, Hu X, Kang J, Zhang J, Jiang J, Hahn JY, Nam CW, Doh JH, Lee BK, Kim W, Huang J, Jiang F, Zhou H, Chen P, Tang L, Jiang W, Chen X, He W, Ahn SG, Yoon MH, Kim U, Lee JM, Hwang D, Ki YJ, Shin ES, Kim HS, Tahk SJ, Wang J; FLAVOUR Investigators. Fractional Flow Reserve or Intravascular Ultrasonography to Guide PCI. N Engl J Med. 2022 Sep 1;387(9):779-789. doi: 10.1056/NEJMoa2201546.

    PubMed 36053504

Questions about this trial

What is this clinical trial studying?

A study testing FFR-guided stenting and IVUS-guided stenting in people with Stable Angina, run by Seoul National University Hospital at 5 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in South Korea, China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient-oriented composite outcome (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02673424, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2025.

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