Fractional FLow Reserve And IVUS for Clinical OUtcomes in Patients With InteRmediate Stenosis
NCT ID: NCT02673424
Last Updated: 2025-02-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
NA
1700 participants
INTERVENTIONAL
2016-06-30
2025-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Fractional Flow Reserve (FFR) Versus Intravascular Ultrasound (IVUS) in Intermediate Coronary Artery Disease
NCT01175863
FFR Versus IVUS with Angiography-Derived FFR for Clinical Outcomes in Patients with Coronary Artery Disease
NCT06218485
Comparison of Fractional Flow Reserve and Intravascular Ultrasound
NCT01133015
Fractional Flow Reserve and Intravascular Ultrasound in Evaluating Intermediate Coronary Lesions
NCT01414361
The Implementation of Intravascular Ultrasound and Fractional Flow Reserve in the Percutaneous Treatment of Very Long Coronary Artery Lesions
NCT05621421
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
5. 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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
FFR-guided stenting
Percutaneous coronaryintervention using drug-eluting stent(s) will be performed by FFR-guided strategy.
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
IVUS-guided stenting
Percutaneous coronaryintervention using drug-eluting stent(s) will be performed by IVUS-guided strategy.
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%)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
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%)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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
19 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Second Affiliated Hospital, School of Medicine, Zhejiang University
OTHER
Samsung Medical Center, Sungkyunkwan University School of Medicine
UNKNOWN
Ulsan University Hospital
OTHER
Keimyung University Dongsan Medical Center
OTHER
Inje University
OTHER
KangWon National University Hospital
OTHER
Ajou University School of Medicine
OTHER
Seoul National University Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Bon-Kwon Koo
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bon-Kwon Koo, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Seung-Jea Tahk, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Ajou University School of Medicine
JianAn Wang, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Second Affiliated Hospital, School of Medicine, Zhejiang University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The Second Affiliated Hospital, School of Medicine, Zhejiang University
Zhejiang, , China
Keimyung University Dongsan Medical Center
Daegu, , South Korea
Inje University Ilsan Paik Hospital
Goyang, , South Korea
Samsung Medical Center, Sungkyunkwan University School of Medicine
Seoul, , South Korea
Seoul National University Hospital, Seoul, Korea
Seoul, , South Korea
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NCT02673424
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.