Angiography-Derived FFR And IVUS for Clinical Outcomes in Patients With Coronary Artery Disease (FLAVOUR II)

January 21, 2024 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

Comparison of Angiography-derived Fractional FLow Reserve- And IntraVascular Ultrasound-guided Intervention Strategy for Clinical OUtcomes in Patients With CoRonary Artery Disease

Comparison of Angiography-derived Fractional FLow Reserve And IntraVascular Ultrasound-guided Intervention Strategy for Clinical OUtcomes in Patients with CoRonary Artery Disease

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

  1. The primary hypothesis is that angiography-derived FFR-guided strategy for PCI with a drug-eluting stent (DES) will show non-inferiority in rates of patients-oriented composite outcomes (POCO) at 12 months after randomization, compared with IVUS-guided strategy for PCI with a DES in patients with coronary artery disease.

  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 12 months after PCI will be 7% in the Angiography-derived FFR-guided arm, and 8% in the IVUS-guided arm

    • Primary endpoint: patient-oriented composite outcome (a composite of all-cause death, MI, any revascularization) at 12 months after PCI
    • Design: non-inferiority, delta = 2.5%
    • Sampling ratio: angiography-derived FFR-guided strategy: IVUS-guided strategy = 1:1
    • Type I error (α): One-sided 2.5%
    • Accrual time: 3 years
    • Total time: 4 years (accrual 3 years + follow-up 1 years)
    • Assumption: POCO 7.0% vs. 8.0% in angiography-derived FFR or IVUS-guided strategy, respectively
    • Statistical power (1- β): 80%
    • Primary statistical method: Kaplan-Meier survival analysis with log-rank test
    • Estimated attrition rate: total 5%
    • Stratification in Randomization: Presence of diabetes mellitus (35% of patients in each group) Based on the above assumption, we would need total 1,872 patients (936 patients in each group) with consideration of an attrition rate.
  3. Research Materials and Indication for Revascularization： For the angiography-derived FFR-guided strategy arm, criteria for revascularization: angiography-derived FFR ≤ 0.80. For the IVUS-guided strategy arm, the criterion for revascularization is MLA ≤ 3mm2 or [3mm2 < MLA ≤ 4mm2 and plaque burden > 70%].

Study Type

Interventional

Enrollment (Estimated)

1872

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China
        • Peking University Third Hospital
      • Guangdong, China
        • Second Affiliated Hospital of Shantou University Medical College
      • Hangzhou, China
        • The Affiliated Hospital of Hangzhou Normal University
      • Hangzhou, China
        • Zhejiang Greentown Cardiovascular Hospital
      • Hangzhou, China
        • Affiliated HangZhou First People's Hospital
      • Huzhou, China
        • Changxing People's Hospital
      • Huzhou, China
        • Huzhou Central Hospital
      • Jinan, China
        • The Fourth People's Hospital of Jinan
      • Jinhua, China
        • Jinhua Central Hospital
      • Jinhua, China
        • Dongyang People's Hospital
      • Kunming, China
        • First Affiliated Hospital of Kunming Medical University
      • Nanchang, China
        • The First Affiliated Hospital of Nanchang University
      • Ningbo, China
        • The Affiliated Hospital of Medical College, Ningbo University
      • Shandong, China
        • Shandong Jining No.1 People's Hospital
      • Shandong, China
        • Shandong University of Traditional Chinese Medicine
      • Shanghai, China
        • Renji Hospital Shanghai Jiaotong University School of Medicine
      • Taiyuan, China
        • Second Hospital of Shanxi Medical University
      • Wenzhou, China
        • The First Affiliated Hospital of Wenzhou Medical University
      • Wenzhou, China
        • The Second Affiliated Hospital of Wenzhou Medical University
      • Wuhan, China
        • Zhongnan Hospital of Wuhan University
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Second Affiliated Hospital, School of Medicine, Zhejiang University, China
  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Seoul National University Hospital,
      • Ulsan, Korea, Republic of
        • Ulsan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • ① Subject must be ≥ 18 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 ≥ 50% stenosis by angiography-based visual estimation eligible for stent implantation. ⑤ Target vessel size ≥ 2.5mm in visual estimation. ⑥ Target vessels are limited to major epicardial coronary arteries (left anterior descending artery[LAD], left circumflex artery [LCX], right coronary artery [RCA])

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). ⑤Non-cardiac co-morbid conditions with life expectancy < 1 year. ⑥ Target vessel total occlusion. ⑦ Target lesion located in coronary arterial bypass graft. ⑧ Left main coronary artery stenosis ≥ 50%. ⑨ Not eligible for angiography-derived FFR (ostial RCA ≥ 50% stenosis, myocardial bridging, severe tortuosity, severe overlap, poor image quality)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Angiography-derived FFR-guided PCI group
Percutaneous coronary intervention using drug-eluting stent(s) will be performed by Angiography-derived FFR-guided strategy
Procedure: Angiography-derived FFR

The percutaneous coronary intervention using drug-eluting stent will be indicated according to following criteria in the Angiography-derived FFR-guided strategy arm

*Criteria for revascularization: Angiography-derived FFR ≤ 0.80
Active Comparator: IVUS-guided PCI group
Percutaneous coronary intervention using drug-eluting stent(s) will be performed by IVUS-guided strategy
Procedure: IVUS

The percutaneous coronary intervention 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 3< MLA ≤ 4mm2 & Plaque burden > 70%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient-oriented composite outcome
Time Frame: 12 months
Patient-oriented composite outcome (POCO), defined as a composite of all death, myocardial infarction (MI) or any revascularization at 12 months after randomization according to the ARC definitions.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cost-effectiveness analysis
Time Frame: 12, 24 and 60 months
Cost-effectiveness analysis
12, 24 and 60 months
All-cause and cardiac death
Time Frame: 12, 24 and 60 months
All-cause and cardiac death
12, 24 and 60 months
Any revascularization (ischemia-driven or all)
Time Frame: 12, 24 and 60 months
Any revascularization (ischemia-driven or all)
12, 24 and 60 months
Stent thrombosis (definite/probable/possible)
Time Frame: 12, 24 and 60 months
Stent thrombosis (definite/probable/possible)
12, 24 and 60 months
Stroke (ischemic and hemorrhagic)
Time Frame: 12, 24 and 60 months
Stroke (ischemic and hemorrhagic)
12, 24 and 60 months
Patient-oriented composite outcome (POCO)
Time Frame: 24, 60 months
POCO at 24 and 60 months after randomization according to the ARC consensus
24, 60 months
Target vessel failure
Time Frame: 12, 24 and 60 months
Target vessel failure (a composite of cardiac death, target-vessel MI, or target vessel revascularization)
12, 24 and 60 months
Any nonfatal MI without peri-procedural MI
Time Frame: 12, 24 and 60 months
Any nonfatal MI without peri-procedural MI
12, 24 and 60 months
Any nonfatal MI with peri-procedural MI
Time Frame: 12, 24 and 60 months
Any nonfatal MI with peri-procedural MI
12, 24 and 60 months
Any target vessel/lesion revascularization
Time Frame: 12, 24 and 60 months
Any target vessel/lesion revascularization
12, 24 and 60 months
Any non-target vessel/lesion revascularization
Time Frame: 12, 24 and 60 months
Any non-target vessel/lesion revascularization
12, 24 and 60 months
Acute success of procedure and rate of PCI optimization
Time Frame: At discharge (1 week after index procedure)
Acute success of procedure and rate of PCI optimization
At discharge (1 week after index procedure)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Collaborators

The First Affiliated Hospital of Nanchang University
Wuhan University
Seoul National University Hospital
Ulsan University Hospital
Peking University Third Hospital
RenJi Hospital
Second Affiliated Hospital of Wenzhou Medical University
First Affiliated Hospital of Wenzhou Medical University
Jinhua Central Hospital
Huizhou Municipal Central Hospital
The Affiliated Hospital of Medical College, Ningbo University
Second Hospital of Shanxi Medical University
Shandong University of Traditional Chinese Medicine
The Affiliated Hospital of Hangzhou Normal University
Changxing People's Hospital
First Affiliated Hospital of Kunming Medical University
Dongyang People's Hospital
Second Affiliated Hospital of Shantou University Medical College
Zhejiang Greentown Cardiovascular Hospital
The Fourth People's Hospital of Jinan
Affiliated Hangzhou First People's Hospital
Jining First People's Hospital

Investigators

  • Principal Investigator: Jian'an Wang, MD, PhD, Second Affiliated Hospital, School of Medicine, Zhejiang University
  • Principal Investigator: Bon-Kwon Koo, MD, PhD, Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 29, 2020

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

September 1, 2028

Study Registration Dates

First Submitted

May 17, 2020

First Submitted That Met QC Criteria

May 17, 2020

First Posted (Actual)

May 21, 2020

Study Record Updates

Last Update Posted (Actual)

January 23, 2024

Last Update Submitted That Met QC Criteria

January 21, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-303

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The deidentified data will be shared after publication of first manuscript

IPD Sharing Time Frame

Data will be available within 12 months of study completion.

IPD Sharing Access Criteria

Data access requests will be reviewed by an external Independent Review Panel. Requestors will be required to sign a Data Access Agreement

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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