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

NCT06218485 · tracked via the Priya Life Science China tracker

Sponsor

Second Affiliated Hospital, Zhejiang University, School of Medicine

Phase

Not applicable

Started

2024-03-13

Last updated

2026-08-27

Condition(s) studied

Coronary Artery Disease

Investigational drug(s) / intervention(s)

Intravascular ultrasound-guided stent implantation after angiography-derived FFR-based decision-makingFractional flow reserve-guided PCI strategy

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

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

Study 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

Sex

ALL

Min age

19 Years

Max age

—

Healthy volunteers

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).

Primary outcome measure(s)

Patient-oriented composite outcome — 24 months
Patient-oriented composite outcome (POCO), defined as a composite of all death, myocardial infarction (MI), or any revascularization at 24 months after randomization.

Trial sites (32)

Facility	City	Region
Peking University Third Hospital	Beijing	China
Xiangya Hospital of Central South University	Changsha	China
The Southwest Hospital of Army Medical University	Chongqing	China
Ganzhou People's Hospital	Ganzhou	China
Second Affiliated Hospital of Shantou University Medical College	Guangdong	China
Hangzhou First People's Hospital	Hangzhou	China
Sir Run Run Shaw Hospital	Hangzhou	China
The Affiliated Hospital of Hangzhou Normal University	Hangzhou	China
The Second Affiliated Hospital of Zhejiang University School of Medicine	Hangzhou	China
Zhejiang Hospital	Hangzhou	China
Changxing People's Hospital	Huzhou	China
Huzhou Central Hospital	Huzhou	China
The Fourth People's Hospital of Jinan	Jinan	China
Jinhua Central Hospital	Jinhua	China
Jining No.1 People's Hospital	Jining	China
The First Affiliated Hospital of Nanchang University	Nanchang	China
The Second Affiliated Hospital of Nanchang University	Nanchang	China
The First Affiliated Hospital of Guangxi Medical University	Nanning	China
Ningbo Medical Center Lihuili Hospital	Ningbo	China
The Affiliated Hospital of Medical College, Ningbo University	Ningbo	China
Shanxi Cardiovascular Hospital	Taiyuan	China
The First Affiliated hospital of Wenzhou Medical University	Wenzhou	China
Renmin Hospital of Wuhan University	Wuhan	China
Wuhan Aisa Heart Hospital	Wuhan	China
The Fifth Affiliated Hospital, Sun Yat-sen University	Zhuhai	China
Inje University Haeundae Paik Hospital	Busan	South Korea
Keimyung University Dongsan Medical Center	Daegu	South Korea
Chonnam National University Hospital	Donggu	South Korea
Inje University Ilsan Paik Hospital	Goyang	South Korea
Seoul National University Hospital,	Seoul	South Korea
Uijeongbu Eulji Medical Center	Uijeongbu-si	South Korea
Ulsan University Hospital	Ulsan	South Korea

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06218485 on ClinicalTrials.gov ↗ ← All trials in China