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RECRUITINGINTERVENTIONAL

FFR Versus IVUS with Angiography-Derived FFR for Clinical Outcomes in Patients with Coronary Artery Disease

Comparison of Fractional Flow Reserve-Guided Strategy Versus Intravascular Ultrasound-Guided Stent Implantation After Angiography-Derived Fractional Flow Reserve-based Decision-Making (The FLAVOUR III Trial)

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

To compare the clinical outcomes of fractional flow reserve (FFR)-guided strategy versus intravascular ultrasound (IVUS)-guided stent implantation after angiography-derived FFR-based decision-making.

Who May Be Eligible (Plain English)

Who May Qualify: - Subject must be ≥ 19 years. - Subject is able to verbally confirm understanding 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 willing to sign a consent form. - Subjects suspected with ischemic heart disease. - Subjects with coronary artery diameter stenosis 50-90% by angiography-based visual estimation eligible for stent implantation. - Target vessel size ≥ 2.5mm in visual estimation. Who Should NOT Join This Trial: - Known hypersensitivity or contraindication to any of the following medications: Heparin, Aspirin, Clopidogrel, Prasugrel, Ticagrelor - Active pathologic bleeding. - Gastrointestinal or genitourinary major bleeding within the prior 3 months. - History of bleeding diathesis, known coagulopathy. - Non-cardiac co-morbid conditions with life expectancy \< 2 years. - Target lesion located in coronary arterial bypass graft. - Left main coronary artery stenosis ≥ 50%. - Chronic total occlusion in the study target vessel. - Culprit lesion of ST-elevation myocardial infarction (STEMI). - Not eligible for angiography-derived FFR (ostial RCA ≥ 50% stenosis, severe tortuosity, severe overlap, poor image quality). Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Subject must be ≥ 19 years. * Subject is able to verbally confirm understanding 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. * Subjects suspected with ischemic heart disease. * Subjects with coronary artery diameter stenosis 50-90% by angiography-based visual estimation eligible for stent implantation. * Target vessel size ≥ 2.5mm in visual estimation. Exclusion Criteria: * Known hypersensitivity or contraindication to any of the following medications: Heparin, Aspirin, Clopidogrel, Prasugrel, Ticagrelor * Active pathologic bleeding. * Gastrointestinal or genitourinary major bleeding within the prior 3 months. * History of bleeding diathesis, known coagulopathy. * Non-cardiac co-morbid conditions with life expectancy \< 2 years. * Target lesion located in coronary arterial bypass graft. * Left main coronary artery stenosis ≥ 50%. * Chronic total occlusion in the study target vessel. * Culprit lesion of ST-elevation myocardial infarction (STEMI). * Not eligible for angiography-derived FFR (ostial RCA ≥ 50% stenosis, severe tortuosity, severe overlap, poor image quality).

Treatments Being Tested

PROCEDURE

Intravascular ultrasound-guided stent implantation after angiography-derived FFR-based decision-making

The percutaneous coronary intervention will be performed by intravascular ultrasound (IVUS)-guided strategy after angiography-derived FFR-based decision-making: 1. PCI will be performed if angiography-derived FFR ≤0.80 and will be deferred if angiography-derived FFR \>0.80. 2. If PCI is performed, PCI optimization using IVUS will be performed following the recommended criteria: ① Plaque burden at stent edge ≤55%; ② Minimal stent area ≥ 5.5 mm2, or minimal stent area ≥ distal reference lumen area

PROCEDURE

Fractional flow reserve-guided PCI strategy

The percutaneous coronary intervention will be performed by fractional flow reserve (FFR)-guided strategy: 1. PCI will be performed if FFR ≤0.80 and will be deferred if FFR \>0.80. 2. If PCI is performed, PCI optimization using FFR will be performed following the recommended criteria: ① Post-PCI FFR ≥ 0.88, or ② Post-PCI ΔFFR (\[FFR at stent distal edge\] - \[FFR at stent proximal edge\]) \< 0.05

Locations (20)

Peking University Third Hospital
Beijing, China
Second Affiliated Hospital of Shantou University Medical College
Guangdong, China
The Affiliated Hospital of Hangzhou Normal University
Hangzhou, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, China
Changxing People's Hospital
Huzhou, China
The Affiliated Hospital of Shandong University of TCM
Jinan, China
The Fourth People's Hospital of Jinan
Jinan, China
Jinhua Central Hospital
Jinhua, China
First Affiliated Hospital of Kunming Medical University
Kunming, China
The First Affiliated Hospital of Nanchang University
Nanchang, China
Ningbo Medical Center Lihuili Hospital
Ningbo, China
The Affiliated Hospital of Medical College, Ningbo University
Ningbo, China
Renji Hospital Shanghai Jiaotong University School of Medicine
Shanghai, China
The First Affiliated hospital of Wenzhou Medical University
Wenzhou, China
Bucheon Sejong Hospital
Bucheon-si, South Korea
Inje University Haeundae Paik Hospital
Busan, South Korea
Keimyung University Dongsan Medical Center
Daegu, South Korea
Kyungpook National University Hospital
Daegu, South Korea
Chonnam National University Hospital
Donggu, South Korea
Inje University Ilsan Paik Hospital
Goyang, South Korea