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)
Status: Recruiting
Location: See all (25) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
China
Peking University Third Hospital
RECRUITING
Beijing
Second Affiliated Hospital of Shantou University Medical College
RECRUITING
Guangdong
The Affiliated Hospital of Hangzhou Normal University
RECRUITING
Hangzhou
The Second Affiliated Hospital of Zhejiang University School of Medicine
NOT_YET_RECRUITING
Hangzhou
Changxing People's Hospital
RECRUITING
Huzhou
The Affiliated Hospital of Shandong University of TCM
NOT_YET_RECRUITING
Jinan
The Fourth People's Hospital of Jinan
RECRUITING
Jinan
Jinhua Central Hospital
RECRUITING
Jinhua
First Affiliated Hospital of Kunming Medical University
NOT_YET_RECRUITING
Kunming
The First Affiliated Hospital of Nanchang University
RECRUITING
Nanchang
Ningbo Medical Center Lihuili Hospital
NOT_YET_RECRUITING
Ningbo
The Affiliated Hospital of Medical College, Ningbo University
RECRUITING
Ningbo
Renji Hospital Shanghai Jiaotong University School of Medicine
NOT_YET_RECRUITING
Shanghai
The First Affiliated hospital of Wenzhou Medical University
RECRUITING
Wenzhou
Republic of Korea
Bucheon Sejong Hospital
NOT_YET_RECRUITING
Bucheon-si
Inje University Haeundae Paik Hospital
NOT_YET_RECRUITING
Busan
Keimyung University Dongsan Medical Center
NOT_YET_RECRUITING
Daegu
Kyungpook National University Hospital
NOT_YET_RECRUITING
Daegu
Chonnam National University Hospital
NOT_YET_RECRUITING
Donggu
Inje University Ilsan Paik Hospital
NOT_YET_RECRUITING
Goyang
Seoul National University Hospital,
RECRUITING
Seoul
Seoul ST. Mary's Hospital
NOT_YET_RECRUITING
Seoul
Uijeongbu Eulji Medical Center
NOT_YET_RECRUITING
Uijeongbu-si
Ulsan University Hospital
NOT_YET_RECRUITING
Ulsan
Yonsei University Wonju Severance Hospital
NOT_YET_RECRUITING
Wŏnju
Contact Information
Primary
Xinyang Hu, MD, PhD
hxy0507@126.com
+86 0571 87784808
Backup
Jinlong Zhang, MD, PhD
jinlong1102@naver.com
+86 15757197513
Time Frame
Start Date: 2024-03-13
Estimated Completion Date: 2029-12-01
Participants
Target number of participants: 1942
Treatments
Experimental: Experimental group
The percutaneous coronary intervention will be performed by intravascular ultrasound (IVUS)-guided strategy after angiography-derived FFR-based decision-making.
Active_comparator: Control group
The percutaneous coronary intervention will be performed by fractional flow reserve (FFR)-guided strategy.
Related Therapeutic Areas
Sponsors
Collaborators: Yonsei University Wonju Severance Hospital, Seoul National University Hospital, Jinhua Central Hospital, The First Affiliated Hospital of Nanchang University, Chonnam National University Hospital, First Affiliated Hospital of Wenzhou Medical University, RenJi Hospital, Inje University Haeundae Paik Hospital, Ningbo Medical Center Lihuili Hospital, First Affiliated Hospital of Kunming Medical University, Seoul St. Mary's Hospital, The Affiliated Hospital of Shandong University of TCM, Uijeongbu Eulji Medical Center, Ulsan University Hospital, The Affiliated Hospital of Hangzhou Normal University, Keimyung University Dongsan Medical Center, The Fourth People's Hospital of Jinan, Second Affiliated Hospital of Shantou University Medical College, Peking University Third Hospital, Sejong General Hospital, The Affiliated Hospital of Medical College, Ningbo University, Changxing People's Hospital, Inje University Ilsan Paik Hospital, Kyungpook National University Hospital
Leads: Second Affiliated Hospital, School of Medicine, Zhejiang University