NCT06218485Active, not recruiting
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)
Source: ClinicalTrials.gov · Last updated 27 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 1942 (estimated)
- First submitted
- 27 Nov 2023
- Start date
- Mar 2024
- Primary completion date
- Sept 2028
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Diseases
- Coronary artery disease
- NCT number
- NCT06218485
What you commit to
- Study type: Interventional
- Planned participants: 1942
- From Mar 2024 to the primary completion date, Sept 2028
- 32 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Gastrointestinal or genitourinary major bleeding within the prior 3 months.
Other illness
- Known hypersensitivity or contraindication to any of the following medications: Heparin, Aspirin, Clopidogrel, Prasugrel, Ticagrelor
- Active pathologic bleeding.
- History of bleeding diathesis, known coagulopathy.
- Culprit lesion of ST-elevation myocardial infarction (STEMI).
Age
- Non-cardiac co-morbid conditions with life expectancy \< 2 years.
Other
- Target lesion located in coronary arterial bypass graft.
- Left main coronary artery stenosis ≥ 50%.
- Chronic total occlusion in the study target vessel.
- Not eligible for angiography-derived FFR (ostial RCA ≥ 50% stenosis, severe tortuosity, severe overlap, poor image quality).
Who the study is looking for
- 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.
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (32)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University Third Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Xiangya Hospital of Central South University Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| The Southwest Hospital of Army Medical University Coordinator of this site? Confirm its status | Chongqing | China | Unknown status |
| Ganzhou People's Hospital Coordinator of this site? Confirm its status | Ganzhou | China | Unknown status |
| Second Affiliated Hospital of Shantou University Medical College Coordinator of this site? Confirm its status | Guangdong | China | Unknown status |
| Sir Run Run Shaw Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Hangzhou First People's Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Zhejiang Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| The Affiliated Hospital of Hangzhou Normal University Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| The Second Affiliated Hospital of Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Changxing people' s hospital Coordinator of this site? Confirm its status | Huzhou | China | Unknown status |
| Huzhou Central Hospital Coordinator of this site? Confirm its status | Huzhou | China | Unknown status |
| The Fourth People's Hospital of Jinan Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
| Jinhua Central Hospital Coordinator of this site? Confirm its status | Jinhua | China | Unknown status |
| Jining No. 1 People's Hospital. Coordinator of this site? Confirm its status | Jining | China | Unknown status |
| The Second Affiliated Hospital of Nanchang University Coordinator of this site? Confirm its status | Nanchang | China | Unknown status |
| The First Affiliated Hospital of NanChang University Coordinator of this site? Confirm its status | Nanchang | China | Unknown status |
| The First Affiliated Hospital of Guangxi Medical University Coordinator of this site? Confirm its status | Nanning | China | Unknown status |
| Ningbo Medical Center Lihuili Hospital Coordinator of this site? Confirm its status | Ningbo | China | Unknown status |
| The Affiliated Hospital of Medical College, Ningbo University Coordinator of this site? Confirm its status | Ningbo | China | Unknown status |
| Shanxi Cardiovascular Hospital Coordinator of this site? Confirm its status | Taiyuan | China | Unknown status |
| The First Affiliated Hospital of Wenzhou Medical University Coordinator of this site? Confirm its status | Wenzhou | China | Unknown status |
| Wuhan Aisa Heart Hospital Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| Renmin Hospital of Wuhan University Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| The Fifth Affiliated Hospital Sun Yat-sen University Coordinator of this site? Confirm its status | Zhuhai | China | Unknown status |
| Inje University Haeundae Paik Hospital Coordinator of this site? Confirm its status | Busan | South Korea | Unknown status |
| Keimyung University - Dongsan Medical Center Coordinator of this site? Confirm its status | Daegu | South Korea | Unknown status |
| Chonnam National University Hospital Coordinator of this site? Confirm its status | Donggu | South Korea | Unknown status |
| Inje University Ilsan Paik Hospital Coordinator of this site? Confirm its status | Goyang | South Korea | Unknown status |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Uijeongbu Eulji Medical Center Coordinator of this site? Confirm its status | Uijeongbu-si | South Korea | Unknown status |
| Ulsan University Hospital Coordinator of this site? Confirm its status | Ulsan | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.