Comparing two methods for guiding stent implantation in 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)

This study is testing whether using intravascular ultrasound or fractional flow reserve to guide stent placement in patients with coronary artery disease leads to better health outcomes over two years.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 1942 (estimated)
• Ages: 19 Years and up
• Sex: All
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University (Academic / other)
• Locations: 25 sites (Beijing and 24 other locations)
• Trial ID: NCT06218485 on ClinicalTrials.gov

What this trial studies

This study aims to compare the clinical outcomes of two strategies for guiding stent implantation in patients with coronary artery disease: one using fractional flow reserve (FFR) and the other using intravascular ultrasound (IVUS) after making decisions based on angiography-derived FFR. The hypothesis is that the IVUS-guided approach will lead to better patient outcomes, specifically a lower rate of adverse events at 24 months. Participants will be randomly assigned to either the FFR-guided or IVUS-guided group, with specific criteria for performing percutaneous coronary intervention (PCI) based on their angiography results. The study will evaluate the effectiveness of these two methods in optimizing stent placement and improving patient health over time.

Who should consider this trial

Good fit: Ideal candidates are adults aged 19 and older with suspected ischemic heart disease and coronary artery stenosis of 50-90% eligible for stent implantation.

Not a fit: Patients with known hypersensitivity to required medications, active bleeding conditions, or non-cardiac comorbidities with a life expectancy of less than two years may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved clinical outcomes for patients undergoing stent implantation for coronary artery disease.

How similar studies have performed: Previous studies have shown promising results with similar approaches, indicating potential for success in this trial.

Eligibility criteria

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).

Where this trial is running

Beijing and 24 other locations

• Peking University Third Hospital — Beijing, China (Recruiting)
• Second Affiliated Hospital of Shantou University Medical College — Guangdong, China (Recruiting)
• The Affiliated Hospital of Hangzhou Normal University — Hangzhou, China (Recruiting)
• The Second Affiliated Hospital of Zhejiang University School of Medicine — Hangzhou, China (Not_yet_recruiting)
• Changxing People's Hospital — Huzhou, China (Recruiting)
• The Affiliated Hospital of Shandong University of TCM — Jinan, China (Not_yet_recruiting)
• The Fourth People's Hospital of Jinan — Jinan, China (Recruiting)
• Jinhua Central Hospital — Jinhua, China (Recruiting)
• First Affiliated Hospital of Kunming Medical University — Kunming, China (Not_yet_recruiting)
• The First Affiliated Hospital of Nanchang University — Nanchang, China (Recruiting)
• Ningbo Medical Center Lihuili Hospital — Ningbo, China (Not_yet_recruiting)
• The Affiliated Hospital of Medical College, Ningbo University — Ningbo, China (Recruiting)
• Renji Hospital Shanghai Jiaotong University School of Medicine — Shanghai, China (Not_yet_recruiting)
• The First Affiliated hospital of Wenzhou Medical University — Wenzhou, China (Recruiting)
• Bucheon Sejong Hospital — Bucheon-si, South Korea (Not_yet_recruiting)
• Inje University Haeundae Paik Hospital — Busan, South Korea (Not_yet_recruiting)
• Keimyung University Dongsan Medical Center — Daegu, South Korea (Not_yet_recruiting)
• Kyungpook National University Hospital — Daegu, South Korea (Not_yet_recruiting)
• Chonnam National University Hospital — Donggu, South Korea (Not_yet_recruiting)
• Inje University Ilsan Paik Hospital — Goyang, South Korea (Not_yet_recruiting)
• Seoul National University Hospital, — Seoul, South Korea (Recruiting)
• Seoul ST. Mary's Hospital — Seoul, South Korea (Not_yet_recruiting)
• Uijeongbu Eulji Medical Center — Uijeongbu-si, South Korea (Not_yet_recruiting)
• Ulsan University Hospital — Ulsan, South Korea (Not_yet_recruiting)
• Yonsei University Wonju Severance Hospital — Wŏnju, South Korea (Not_yet_recruiting)

Study contacts

• Principal investigator: Jian'an Wang, MD, PhD — Second Affiliated Hospital, School of Medicine, Zhejiang University
• Study coordinator: Xinyang Hu, MD, PhD

Conditions Coronary Artery Disease; Angiography-derived fractional flow reserve; Intravascular ultrasound; Fractional flow reserve; Percutaneous coronary intervention