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)
Second Affiliated Hospital, School of Medicine, Zhejiang University
1,942 participants
Mar 13, 2024
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria5
- 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 Criteria10
- 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).
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Interventions
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
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(25)
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NCT06218485