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
CRIS Registration Number |
KCT0003100 |
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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
Board Approval Status | Submitted approval |
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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 Person for Principal Investigator / Scientific Queries | |
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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
Study Site | Multi-center Number of center : 8 - Multi-national} | |
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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
1. Source of Monetary/Material Support | |
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Organization Name | Boston Scientific Korea |
Organization Type | Others |
Project ID |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Seoul National University Hospital |
Organization Type | Medical Institute |
7. Study Summary
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. |
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8. Study Design
Study Type | Interventional Study |
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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 |
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Arm Type Active comparator |
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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. |
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Arm 2 |
Arm Label IVUS-guided strategy arm |
Target Number of Participant 850 |
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Arm Type Active comparator |
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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
Condition(s)/Problem(s) |
* (I00-I99)Diseases of the circulatory system (I25.1)Atherosclerotic heart disease |
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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 |
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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)
Type of Primary Outcome | /Safety/Efficacy | |
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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 |
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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) |
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Timepoint | 24 months after randomization |
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Secondary Outcome(s) 3 | ||
Outcome | All-cause and cardiac death |
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Timepoint | 24 months after randomization |
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Secondary Outcome(s) 4 | ||
Outcome | Target-vessel and all-cause nonfatal MI without peri-procedural MI |
|
Timepoint | 24 months after randomization |
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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) |
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Timepoint | 24 months after randomization |
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Secondary Outcome(s) 7 | ||
Outcome | Non-target vessel/lesion revascularization (ischemia-driven or all) |
|
Timepoint | 24 months after randomization |
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Secondary Outcome(s) 8 | ||
Outcome | Any revascularization (ischemia-driven or all) |
|
Timepoint | 24 months after randomization |
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Secondary Outcome(s) 9 | ||
Outcome | Stent thrombosis (definite/probable/possible) |
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Timepoint | 24 months after randomization |
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Secondary Outcome(s) 10 | ||
Outcome | Stroke (ischemic and hemorrhagic) |
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Timepoint | 24 months after randomization |
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Secondary Outcome(s) 11 | ||
Outcome | Acute success of procedure (device, lesion and procedure) |
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Timepoint | 24 months after randomization |
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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
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | Not provided at time of Registration |
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