NCT02673424

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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,700

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2016

Longer than P75 for not_applicable

Geographic Reach
2 countries

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 1, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 3, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
8.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

February 10, 2025

Status Verified

May 1, 2020

Enrollment Period

8.7 years

First QC Date

February 1, 2016

Last Update Submit

February 5, 2025

Conditions

Stable Angina

Outcome Measures

Primary Outcomes (2)

  • Patient-oriented composite outcome

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

    24 months

  • 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.

    Up to 7 years

Secondary Outcomes (39)

  • Patient-oriented composite outcome

    12 months

  • Stent-oriented composite endpoint

    12 months

  • Stent-oriented composite endpoint

    24 months

  • Cost-effectiveness analysis

    24 months

  • All-cause death

    24 months

  • +34 more secondary outcomes

Study Arms (2)

FFR-guided stenting

ACTIVE COMPARATOR

Percutaneous coronaryintervention using drug-eluting stent(s) will be performed by FFR-guided strategy.

Procedure: FFR-guided stenting

IVUS-guided stenting

ACTIVE COMPARATOR

Percutaneous coronaryintervention using drug-eluting stent(s) will be performed by IVUS-guided strategy.

Procedure: IVUS-guided stenting

Interventions

FFR-guided stentingPROCEDURE

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

FFR-guided stenting
IVUS-guided stentingPROCEDURE

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%)

IVUS-guided stenting

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

The Second Affiliated Hospital, School of Medicine, Zhejiang University

Zhejiang, China

Location

Keimyung University Dongsan Medical Center

Daegu, South Korea

Location

Inje University Ilsan Paik Hospital

Goyang, South Korea

Location

Samsung Medical Center, Sungkyunkwan University School of Medicine

Seoul, 135-710, South Korea

Location

Seoul National University Hospital, Seoul, Korea

Seoul, South Korea

Location

Related Publications (5)

  • 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.

    PMID: 39886193DERIVED

  • 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.

    PMID: 39601394DERIVED

  • 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.

    PMID: 38956940DERIVED

  • 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.

    PMID: 38018840DERIVED

  • 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.

    PMID: 36053504DERIVED

MeSH Terms

Conditions

Angina, Stable

Condition Hierarchy (Ancestors)

Angina PectorisMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 1, 2016

First Posted

February 3, 2016

Study Start

June 1, 2016

Primary Completion

February 1, 2025

Study Completion

December 1, 2025

Last Updated

February 10, 2025

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will share

The deidentified data will be shared after publication of first manuscript

Shared Documents
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

Locations

CN(1)KR(4)