Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02673424
Recruitment Status : Recruiting
First Posted : February 3, 2016
Last Update Posted : July 2, 2018
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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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 repeat revascularization


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

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

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

  6. 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

  7. 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

  8. Target vessel/lesion revascularization [ Time Frame: 24 months ]
    ischemia-driven or all

  9. Non-target vessel/lesion revascularization [ Time Frame: 24 months ]
    ischemia-driven or all

  10. Any revascularization [ Time Frame: 24 months ]
    ischemia-driven or all

  11. Academic Research Consortium defined - Stent thrombosis [ Time Frame: 24 months ]
    definite/probable/possible

  12. Stroke [ Time Frame: 24 months ]
    ischemic or hemorrhagic stroke

  13. Acute success of procedure [ Time Frame: At discharge (1 week after index procedure) ]
    Device-related, lesion-related and procedure-related success of the procedure

  14. Angina severity measured with Seattle Angina Questionnaires [ Time Frame: 12 months ]
    Seattle Angina Questionnaires

  15. Angina severity measured with Seattle Angina Questionnaires [ Time Frame: 24 months ]
    Seattle Angina Questionnaires



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.


Layout table for eligibility information
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


Contacts
Layout table for location contacts
Contact: Bon-Kwon Koo, MD, PhD 82-2-2072-2062 bkkoo@snu.ac.kr
Contact: Joo Myung Lee, MD, MPH, PhD 82-2-3410-3391 drone80@hanmail.net

Locations
Layout table for location information
China
The Second Affiliated Hospital, School of Medicine, Zhejiang University Recruiting
Zhejiang, China
Contact: JianAn Wang, MD, PhD       wang_jian_an@tom.com   
Korea, Republic of
Keimyung University Dongsan Medical Center Recruiting
Daegu, Korea, Republic of
Contact: Chang-Wook Nam, MD,PhD       namcwcv@gmail.com   
Inje University Ilsan Paik Hospital Recruiting
Goyang, Korea, Republic of
Contact: Joon-Hyung Doh, MD, PhD       joon.doh@gmail.com   
Samsung Medical Center, Sungkyunkwan University School of Medicine Recruiting
Seoul, Korea, Republic of, 135-710
Contact: Joo Myung Lee, MD, MPH, PhD    82-10-8884-8439    drone80@hanmail.net   
Contact: Joo-Yong Hahn, MD,PhD       ichjy1@gmail.com   
Sub-Investigator: Young Bin Song, MD, PhD         
Seoul National University Hospital, Seoul, Korea Recruiting
Seoul, Korea, Republic of
Contact: Bon-Kwon Koo, MD    82-2-2072-2062    bkkoo@snu.ac.kr   
Contact: Jeehoon Kang, MD    82-2-2072-2062    medikang@gmail.com   
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
Layout table for investigator information
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

Layout table for additonal information
Responsible Party: Bon-Kwon Koo, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02673424     History of Changes
First Posted: February 3, 2016    Key Record Dates
Last Update Posted: July 2, 2018
Last Verified: June 2018
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:
Layout table for MeSH terms
Angina, Stable
Angina Pectoris
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Neurologic Manifestations
Signs and Symptoms