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RECRUITING
NCT06218485
NA

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

Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

All

Age Range

19 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1942

Start Date

2024-03-13

Completion Date

2029-12-01

Last Updated

2025-02-24

Healthy Volunteers

No

Interventions

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 (25)

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

Seoul National University Hospital,

Seoul, South Korea

Seoul ST. Mary's Hospital

Seoul, South Korea

Uijeongbu Eulji Medical Center

Uijeongbu-si, South Korea

Ulsan University Hospital

Ulsan, South Korea

Yonsei University Wonju Severance Hospital

Wŏnju, South Korea