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ACTIVE NOT RECRUITING
NCT06218485
NA

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

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

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

2031-09-01

Last Updated

2026-08-27

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 (32)

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