Back to resultsAngiography-Derived FFR And IVUS for Clinical Outcomes in Patients With Coronary Artery Disease (FLAVOUR II)
Primary Purpose
Coronary Artery Disease
Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Angiography-derived FFR
IVUS
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring Angiography-derived fractional flow reserve, Intravascular ultrasound, Percutaneous coronary intervention, Fractional flow reserve
Eligibility Criteria
Inclusion Criteria:
- ① Subject must be ≥ 18 years. ② Subject is able to verbally confirm understandings 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 prior to any study related procedure. ③ Patients suspected with ischemic heart disease. ④ Patients with ≥ 50 stenosis by angiography-based visual estimation eligible for stent implantation. ⑤ Target vessel size ≥ 2.5mm in visual estimation. ⑥ Target vessels are limited to major epicardial coronary arteries (left anterior descending artery[LAD], left circumflex artery [LCX], right coronary artery [RCA])
Exclusion Criteria:
- ① The patient has a known hypersensitivity or contraindication to any of the following medications: Heparin, Aspirin, Clopidogrel, Prasugrel, Ticagrelor, Contrast media (Patients with documented sensitivity to contrast media which can be effectively premedicated with steroids and diphenhydramine [e.g. rash] may be enrolled.) ② Patients with active pathologic bleeding. ③ Gastrointestinal or genitourinary major bleeding within the prior 3 months. ④ History of bleeding. diathesis, known coagulopathy (including heparin-induced thrombocytopenia). ⑤Non-cardiac co-morbid conditions with life expectancy < 1 year. ⑥ Target vessel total occlusion. ⑦ Target lesion located in coronary arterial bypass graft. ⑧ Left main coronary artery stenosis ≥ 50%. ⑨ Not eligible for angiography-derived FFR (ostial RCA ≥ 50% stenosis, myocardial bridging, severe tortuosity, severe overlap, poor image quality)
Sites / Locations
- Second Affiliated Hospital, School of Medicine, Zhejiang University, ChinaRecruiting
- Peking University Third HospitalRecruiting
- Second Affiliated Hospital of Shantou University Medical CollegeRecruiting
- Affiliated Hangzhou First People's HospitalRecruiting
- The Affiliated Hospital of Hangzhou Normal UniversityRecruiting
- Zhejiang Greentown Cardiovascular HospitalRecruiting
- Changxing People's HospitalRecruiting
- Huzhou Central HospitalRecruiting
- The Fourth People's Hospital of JinanRecruiting
- Dongyang People's HospitalRecruiting
- Jinhua Central HospitalRecruiting
- First Affiliated Hospital of Kunming Medical University
- The First Affiliated Hospital of Nanchang UniversityRecruiting
- The Affiliated Hospital of Medical College, Ningbo UniversityRecruiting
- Shandong Jining No.1 People's HospitalRecruiting
- Shandong University of Traditional Chinese MedicineRecruiting
- Renji Hospital Shanghai Jiaotong University School of MedicineRecruiting
- Second hospital of Shanxi Medical UniversityRecruiting
- The first affiliated hospital of Wenzhou Medical UniversityRecruiting
- The second affiliated hospital of Wenzhou Medical UniversityRecruiting
- Zhongnan Hospital of Wuhan UniversityRecruiting
- Seoul National University Hospital,
- Ulsan University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Angiography-derived FFR-guided PCI group
IVUS-guided PCI group
Arm Description
Percutaneous coronary intervention using drug-eluting stent(s) will be performed by Angiography-derived FFR-guided strategy
Percutaneous coronary intervention using drug-eluting stent(s) will be performed by IVUS-guided strategy
Outcomes
Primary Outcome Measures
Patient-oriented composite outcome
Patient-oriented composite outcome (POCO), defined as a composite of all death, myocardial infarction (MI) or any revascularization at 12 months after randomization according to the ARC definitions.
Secondary Outcome Measures
Patient-oriented composite outcome (POCO)
POCO at 24 and 60 months after randomization according to the ARC consensus
Target vessel failure
Target vessel failure (a composite of cardiac death, target-vessel MI, or target vessel revascularization)
Cost-effectiveness analysis
Cost-effectiveness analysis
All-cause and cardiac death
All-cause and cardiac death
Any nonfatal MI without peri-procedural MI
Any nonfatal MI without peri-procedural MI
Any nonfatal MI with peri-procedural MI
Any nonfatal MI with peri-procedural MI
Any target vessel/lesion revascularization
Any target vessel/lesion revascularization
Any non-target vessel/lesion revascularization
Any non-target vessel/lesion revascularization
Any revascularization (ischemia-driven or all)
Any revascularization (ischemia-driven or all)
Stent thrombosis (definite/probable/possible)
Stent thrombosis (definite/probable/possible)
Stroke (ischemic and hemorrhagic)
Stroke (ischemic and hemorrhagic)
Acute success of procedure and rate of PCI optimization
Acute success of procedure and rate of PCI optimization
Full Information
NCT ID
NCT04397211
First Posted
May 17, 2020
Last Updated
February 10, 2023
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators
Seoul National University Hospital, Affiliated Hangzhou First People's Hospital, Wuhan University, Peking University Third Hospital, The Affiliated Hospital of Hangzhou Normal University, RenJi Hospital, Second Hospital of Shanxi Medical University, First Affiliated Hospital of Wenzhou Medical University, Second Affiliated Hospital of Wenzhou Medical University, Changxing People's Hospital, The Affiliated Hospital of Medical College, Ningbo University, Jinhua Central Hospital, Shandong University of Traditional Chinese Medicine, Dongyang People's Hospital, The First Affiliated Hospital of Nanchang University, Shandong Jining No.1 People's Hospital, Second Affiliated Hospital of Shantou University Medical College, Ulsan University Hospital, Huizhou Municipal Central Hospital, Zhejiang Greentown Cardiovascular Hospital, The Fourth People's Hospital of Jinan, First Affiliated Hospital of Kunming Medical University
1. Study Identification
Unique Protocol Identification Number
NCT04397211
Brief Title
Angiography-Derived FFR And IVUS for Clinical Outcomes in Patients With Coronary Artery Disease
Acronym
FLAVOUR II
Official Title
Comparison of Angiography-derived Fractional FLow Reserve- And IntraVascular Ultrasound-guided Intervention Strategy for Clinical OUtcomes in Patients With CoRonary Artery Disease
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 29, 2020 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
May 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators
Seoul National University Hospital, Affiliated Hangzhou First People's Hospital, Wuhan University, Peking University Third Hospital, The Affiliated Hospital of Hangzhou Normal University, RenJi Hospital, Second Hospital of Shanxi Medical University, First Affiliated Hospital of Wenzhou Medical University, Second Affiliated Hospital of Wenzhou Medical University, Changxing People's Hospital, The Affiliated Hospital of Medical College, Ningbo University, Jinhua Central Hospital, Shandong University of Traditional Chinese Medicine, Dongyang People's Hospital, The First Affiliated Hospital of Nanchang University, Shandong Jining No.1 People's Hospital, Second Affiliated Hospital of Shantou University Medical College, Ulsan University Hospital, Huizhou Municipal Central Hospital, Zhejiang Greentown Cardiovascular Hospital, The Fourth People's Hospital of Jinan, First Affiliated Hospital of Kunming Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Comparison of Angiography-derived Fractional FLow Reserve And IntraVascular Ultrasound-guided Intervention Strategy for Clinical OUtcomes in Patients with CoRonary Artery Disease
Detailed Description
The primary hypothesis is that angiography-derived FFR-guided strategy for PCI with a drug-eluting stent (DES) will show non-inferiority in rates of patients-oriented composite outcomes (POCO) at 12 months after randomization, compared with IVUS-guided strategy for PCI with a DES in patients with coronary artery disease.
Study population and sample size calculation： Sample size calculation based on the event rates of previous trials, investigators predicted the rates of POCO at 12 months after PCI will be 7% in the Angiography-derived FFR-guided arm, and 8% in the IVUS-guided arm
Primary endpoint: patient-oriented composite outcome (a composite of all-cause death, MI, any revascularization) at 12 months after PCI
Design: non-inferiority, delta = 2.5%
Sampling ratio: angiography-derived FFR-guided strategy: IVUS-guided strategy = 1:1
Type I error (α): One-sided 2.5%
Accrual time: 3 years
Total time: 4 years (accrual 3 years + follow-up 1 years)
Assumption: POCO 7.0% vs. 8.0% in angiography-derived FFR or IVUS-guided strategy, respectively
Statistical power (1- β): 80%
Primary statistical method: Kaplan-Meier survival analysis with log-rank test
Estimated attrition rate: total 5%
Stratification in Randomization: Presence of diabetes mellitus (35% of patients in each group) Based on the above assumption, we would need total 1,872 patients (936 patients in each group) with consideration of an attrition rate.
Research Materials and Indication for Revascularization： For the angiography-derived FFR-guided strategy arm, criteria for revascularization: angiography-derived FFR ≤ 0.80. For the IVUS-guided strategy arm, the criterion for revascularization is MLA ≤ 3mm2 or [3mm2 < MLA ≤ 4mm2 and plaque burden > 70%].
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Angiography-derived fractional flow reserve, Intravascular ultrasound, Percutaneous coronary intervention, Fractional flow reserve
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1872 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Angiography-derived FFR-guided PCI group
Arm Type
Active Comparator
Arm Description
Percutaneous coronary intervention using drug-eluting stent(s) will be performed by Angiography-derived FFR-guided strategy
Arm Title
IVUS-guided PCI group
Arm Type
Active Comparator
Arm Description
Percutaneous coronary intervention using drug-eluting stent(s) will be performed by IVUS-guided strategy
Intervention Type
Procedure
Intervention Name(s)
Angiography-derived FFR
Intervention Description
The percutaneous coronary intervention using drug-eluting stent will be indicated according to following criteria in the Angiography-derived FFR-guided strategy arm
*Criteria for revascularization: Angiography-derived FFR ≤ 0.80
Intervention Type
Procedure
Intervention Name(s)
IVUS
Intervention Description
The percutaneous coronary intervention using drug-eluting stent will be indicated according to following criteria in the IVUS-guided strategy arm
*Criteria for revascularization: Minimum lumen area (MLA) ≤ 3mm2 or 3< MLA ≤ 4mm2 & Plaque burden > 70%
Primary Outcome Measure Information:
Title
Patient-oriented composite outcome
Description
Patient-oriented composite outcome (POCO), defined as a composite of all death, myocardial infarction (MI) or any revascularization at 12 months after randomization according to the ARC definitions.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Patient-oriented composite outcome (POCO)
Description
POCO at 24 and 60 months after randomization according to the ARC consensus
Time Frame
24, 60 months
Title
Target vessel failure
Description
Target vessel failure (a composite of cardiac death, target-vessel MI, or target vessel revascularization)
Time Frame
12, 24 and 60 months
Title
Cost-effectiveness analysis
Description
Cost-effectiveness analysis
Time Frame
12, 24 and 60 months
Title
All-cause and cardiac death
Description
All-cause and cardiac death
Time Frame
12, 24 and 60 months
Title
Any nonfatal MI without peri-procedural MI
Description
Any nonfatal MI without peri-procedural MI
Time Frame
12, 24 and 60 months
Title
Any nonfatal MI with peri-procedural MI
Description
Any nonfatal MI with peri-procedural MI
Time Frame
12, 24 and 60 months
Title
Any target vessel/lesion revascularization
Description
Any target vessel/lesion revascularization
Time Frame
12, 24 and 60 months
Title
Any non-target vessel/lesion revascularization
Description
Any non-target vessel/lesion revascularization
Time Frame
12, 24 and 60 months
Title
Any revascularization (ischemia-driven or all)
Description
Any revascularization (ischemia-driven or all)
Time Frame
12, 24 and 60 months
Title
Stent thrombosis (definite/probable/possible)
Description
Stent thrombosis (definite/probable/possible)
Time Frame
12, 24 and 60 months
Title
Stroke (ischemic and hemorrhagic)
Description
Stroke (ischemic and hemorrhagic)
Time Frame
12, 24 and 60 months
Title
Acute success of procedure and rate of PCI optimization
Description
Acute success of procedure and rate of PCI optimization
Time Frame
At discharge (1 week after index procedure)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
① Subject must be ≥ 18 years. ② Subject is able to verbally confirm understandings 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 prior to any study related procedure. ③ Patients suspected with ischemic heart disease. ④ Patients with ≥ 50% stenosis by angiography-based visual estimation eligible for stent implantation. ⑤ Target vessel size ≥ 2.5mm in visual estimation. ⑥ Target vessels are limited to major epicardial coronary arteries (left anterior descending artery[LAD], left circumflex artery [LCX], right coronary artery [RCA])
Exclusion Criteria:
① The patient has a known hypersensitivity or contraindication to any of the following medications: Heparin, Aspirin, Clopidogrel, Prasugrel, Ticagrelor, Contrast media (Patients with documented sensitivity to contrast media which can be effectively premedicated with steroids and diphenhydramine [e.g. rash] may be enrolled.) ② Patients with active pathologic bleeding. ③ Gastrointestinal or genitourinary major bleeding within the prior 3 months. ④ History of bleeding. diathesis, known coagulopathy (including heparin-induced thrombocytopenia). ⑤Non-cardiac co-morbid conditions with life expectancy < 1 year. ⑥ Target vessel total occlusion. ⑦ Target lesion located in coronary arterial bypass graft. ⑧ Left main coronary artery stenosis ≥ 50%. ⑨ Not eligible for angiography-derived FFR (ostial RCA ≥ 50% stenosis, myocardial bridging, severe tortuosity, severe overlap, poor image quality)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jian'an Wang, MD, PhD
Phone
+86 0571 87784808
Email
wangjianan111@zju.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Xinyang Hu, MD, PhD
Phone
+86 0571 87784808
Email
hxy0507@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jian'an Wang, MD, PhD
Organizational Affiliation
Second Affiliated Hospital, School of Medicine, Zhejiang University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bon-Kwon Koo, MD, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Second Affiliated Hospital, School of Medicine, Zhejiang University, China
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jian'an Wang, MD, PhD
Email
wangjianan111@zju.edu.cn
First Name & Middle Initial & Last Name & Degree
Jinlong Zhang, MD, PhD
Email
jinlong1102@zju.edu.cn
Facility Name
Peking University Third Hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lijun Guo, MD, PhD
Phone
13601234630
Email
guo_li_jun@sohu.com
Facility Name
Second Affiliated Hospital of Shantou University Medical College
City
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jilin Li, MD
Facility Name
Affiliated Hangzhou First People's Hospital
City
Hangzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jinyu Huang, MD, PhD
Phone
13819480927
Email
hk0913@163.com
Facility Name
The Affiliated Hospital of Hangzhou Normal University
City
Hangzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fan Jiang, MD, PhD
Phone
13588097533
Email
13588097533@163.com
Facility Name
Zhejiang Greentown Cardiovascular Hospital
City
Hangzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shiqiang Li, MD
Facility Name
Changxing People's Hospital
City
Huzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dongsheng Lu, MD
Facility Name
Huzhou Central Hospital
City
Huzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhenfeng Cheng, MD
Facility Name
The Fourth People's Hospital of Jinan
City
Jinan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qiang Liu, MD
Facility Name
Dongyang People's Hospital
City
Jinhua
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongping Si, MD
Facility Name
Jinhua Central Hospital
City
Jinhua
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yibin Pan, MD
Facility Name
First Affiliated Hospital of Kunming Medical University
City
Kunming
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meng Zhaohui, MD
Email
zhhmeng@aliyun.com
Facility Name
The First Affiliated Hospital of Nanchang University
City
Nanchang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoping Peng, MD
Facility Name
The Affiliated Hospital of Medical College, Ningbo University
City
Ningbo
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenming He, MD
Facility Name
Shandong Jining No.1 People's Hospital
City
Shandong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daqing Song, MD
Facility Name
Shandong University of Traditional Chinese Medicine
City
Shandong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianliang Ma, MD
Facility Name
Renji Hospital Shanghai Jiaotong University School of Medicine
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Bu
Phone
13817577592
Email
13817577592@139.com
Facility Name
Second hospital of Shanxi Medical University
City
Taiyuan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bin Yang
Phone
13546355355
Facility Name
The first affiliated hospital of Wenzhou Medical University
City
Wenzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hao Zhao
Phone
13968801939
Facility Name
The second affiliated hospital of Wenzhou Medical University
City
Wenzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peng Chen
Phone
13506660597
Facility Name
Zhongnan Hospital of Wuhan University
City
Wuhan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yongzhen Fan, MD, PhD
Phone
18062418952
Email
fanshizhang@163.com
Facility Name
Seoul National University Hospital,
City
Seoul
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Ulsan University Hospital
City
Ulsan
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The deidentified data will be shared after publication of first manuscript
IPD Sharing Time Frame
Data will be available within 12 months of study completion.
IPD Sharing Access Criteria
Data access requests will be reviewed by an external Independent Review Panel. Requestors will be required to sign a Data Access Agreement
Citations:
PubMed Identifier
22070834
Citation
Levine GN, Bates ER, Blankenship JC, Bailey SR, Bittl JA, Cercek B, Chambers CE, Ellis SG, Guyton RA, Hollenberg SM, Khot UN, Lange RA, Mauri L, Mehran R, Moussa ID, Mukherjee D, Nallamothu BK, Ting HH; American College of Cardiology Foundation; American Heart Association Task Force on Practice Guidelines; Society for Cardiovascular Angiography and Interventions. 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention. A report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Society for Cardiovascular Angiography and Interventions. J Am Coll Cardiol. 2011 Dec 6;58(24):e44-122. doi: 10.1016/j.jacc.2011.08.007. Epub 2011 Nov 7. No abstract available.
Results Reference
result
PubMed Identifier
25176289
Citation
De Bruyne B, Fearon WF, Pijls NH, Barbato E, Tonino P, Piroth Z, Jagic N, Mobius-Winckler S, Rioufol G, Witt N, Kala P, MacCarthy P, Engstrom T, Oldroyd K, Mavromatis K, Manoharan G, Verlee P, Frobert O, Curzen N, Johnson JB, Limacher A, Nuesch E, Juni P; FAME 2 Trial Investigators. Fractional flow reserve-guided PCI for stable coronary artery disease. N Engl J Med. 2014 Sep 25;371(13):1208-17. doi: 10.1056/NEJMoa1408758. Epub 2014 Sep 1. Erratum In: N Engl J Med. 2014 Oct 9;371(15):1465.
Results Reference
result
PubMed Identifier
20298990
Citation
Melikian N, De Bondt P, Tonino P, De Winter O, Wyffels E, Bartunek J, Heyndrickx GR, Fearon WF, Pijls NH, Wijns W, De Bruyne B. Fractional flow reserve and myocardial perfusion imaging in patients with angiographic multivessel coronary artery disease. JACC Cardiovasc Interv. 2010 Mar;3(3):307-14. doi: 10.1016/j.jcin.2009.12.010.
Results Reference
result
PubMed Identifier
17531660
Citation
Pijls NH, van Schaardenburgh P, Manoharan G, Boersma E, Bech JW, van't Veer M, Bar F, Hoorntje J, Koolen J, Wijns W, de Bruyne B. Percutaneous coronary intervention of functionally nonsignificant stenosis: 5-year follow-up of the DEFER Study. J Am Coll Cardiol. 2007 May 29;49(21):2105-11. doi: 10.1016/j.jacc.2007.01.087. Epub 2007 May 17.
Results Reference
result
PubMed Identifier
30963676
Citation
Westra J, Tu S, Campo G, Qiao S, Matsuo H, Qu X, Koltowski L, Chang Y, Liu T, Yang J, Andersen BK, Eftekhari A, Christiansen EH, Escaned J, Wijns W, Xu B, Holm NR. Diagnostic performance of quantitative flow ratio in prospectively enrolled patients: An individual patient-data meta-analysis. Catheter Cardiovasc Interv. 2019 Nov 1;94(5):693-701. doi: 10.1002/ccd.28283. Epub 2019 Apr 9.
Results Reference
result
PubMed Identifier
30586699
Citation
Fearon WF, Achenbach S, Engstrom T, Assali A, Shlofmitz R, Jeremias A, Fournier S, Kirtane AJ, Kornowski R, Greenberg G, Jubeh R, Kolansky DM, McAndrew T, Dressler O, Maehara A, Matsumura M, Leon MB, De Bruyne B; FAST-FFR Study Investigators. Accuracy of Fractional Flow Reserve Derived From Coronary Angiography. Circulation. 2019 Jan 22;139(4):477-484. doi: 10.1161/CIRCULATIONAHA.118.037350.
Results Reference
result
PubMed Identifier
29555835
Citation
Westra J, Tu S, Winther S, Nissen L, Vestergaard MB, Andersen BK, Holck EN, Fox Maule C, Johansen JK, Andreasen LN, Simonsen JK, Zhang Y, Kristensen SD, Maeng M, Kaltoft A, Terkelsen CJ, Krusell LR, Jakobsen L, Reiber JHC, Lassen JF, Bottcher M, Botker HE, Christiansen EH, Holm NR. Evaluation of Coronary Artery Stenosis by Quantitative Flow Ratio During Invasive Coronary Angiography: The WIFI II Study (Wire-Free Functional Imaging II). Circ Cardiovasc Imaging. 2018 Mar;11(3):e007107. doi: 10.1161/CIRCIMAGING.117.007107.
Results Reference
result
PubMed Identifier
29980523
Citation
Westra J, Andersen BK, Campo G, Matsuo H, Koltowski L, Eftekhari A, Liu T, Di Serafino L, Di Girolamo D, Escaned J, Nef H, Naber C, Barbierato M, Tu S, Neghabat O, Madsen M, Tebaldi M, Tanigaki T, Kochman J, Somi S, Esposito G, Mercone G, Mejia-Renteria H, Ronco F, Botker HE, Wijns W, Christiansen EH, Holm NR. Diagnostic Performance of In-Procedure Angiography-Derived Quantitative Flow Reserve Compared to Pressure-Derived Fractional Flow Reserve: The FAVOR II Europe-Japan Study. J Am Heart Assoc. 2018 Jul 6;7(14):e009603. doi: 10.1161/JAHA.118.009603.
Results Reference
result
PubMed Identifier
30137305
Citation
Collet C, Onuma Y, Sonck J, Asano T, Vandeloo B, Kornowski R, Tu S, Westra J, Holm NR, Xu B, de Winter RJ, Tijssen JG, Miyazaki Y, Katagiri Y, Tenekecioglu E, Modolo R, Chichareon P, Cosyns B, Schoors D, Roosens B, Lochy S, Argacha JF, van Rosendael A, Bax J, Reiber JHC, Escaned J, De Bruyne B, Wijns W, Serruys PW. Diagnostic performance of angiography-derived fractional flow reserve: a systematic review and Bayesian meta-analysis. Eur Heart J. 2018 Sep 14;39(35):3314-3321. doi: 10.1093/eurheartj/ehy445. Erratum In: Eur Heart J. 2019 Jan 21;40(4):356.
Results Reference
result
PubMed Identifier
29101020
Citation
Xu B, Tu S, Qiao S, Qu X, Chen Y, Yang J, Guo L, Sun Z, Li Z, Tian F, Fang W, Chen J, Li W, Guan C, Holm NR, Wijns W, Hu S. Diagnostic Accuracy of Angiography-Based Quantitative Flow Ratio Measurements for Online Assessment of Coronary Stenosis. J Am Coll Cardiol. 2017 Dec 26;70(25):3077-3087. doi: 10.1016/j.jacc.2017.10.035. Epub 2017 Oct 31.
Results Reference
result
PubMed Identifier
27712739
Citation
Tu S, Westra J, Yang J, von Birgelen C, Ferrara A, Pellicano M, Nef H, Tebaldi M, Murasato Y, Lansky A, Barbato E, van der Heijden LC, Reiber JHC, Holm NR, Wijns W; FAVOR Pilot Trial Study Group. Diagnostic Accuracy of Fast Computational Approaches to Derive Fractional Flow Reserve From Diagnostic Coronary Angiography: The International Multicenter FAVOR Pilot Study. JACC Cardiovasc Interv. 2016 Oct 10;9(19):2024-2035. doi: 10.1016/j.jcin.2016.07.013.
Results Reference
result
PubMed Identifier
15808753
Citation
Fujii K, Carlier SG, Mintz GS, Yang YM, Moussa I, Weisz G, Dangas G, Mehran R, Lansky AJ, Kreps EM, Collins M, Stone GW, Moses JW, Leon MB. Stent underexpansion and residual reference segment stenosis are related to stent thrombosis after sirolimus-eluting stent implantation: an intravascular ultrasound study. J Am Coll Cardiol. 2005 Apr 5;45(7):995-8. doi: 10.1016/j.jacc.2004.12.066.
Results Reference
result
PubMed Identifier
24685326
Citation
Ahn JM, Kang SJ, Yoon SH, Park HW, Kang SM, Lee JY, Lee SW, Kim YH, Lee CW, Park SW, Mintz GS, Park SJ. Meta-analysis of outcomes after intravascular ultrasound-guided versus angiography-guided drug-eluting stent implantation in 26,503 patients enrolled in three randomized trials and 14 observational studies. Am J Cardiol. 2014 Apr 15;113(8):1338-47. doi: 10.1016/j.amjcard.2013.12.043. Epub 2014 Jan 31.
Results Reference
result
PubMed Identifier
20723852
Citation
Nam CW, Yoon HJ, Cho YK, Park HS, Kim H, Hur SH, Kim YN, Chung IS, Koo BK, Tahk SJ, Fearon WF, Kim KB. Outcomes of percutaneous coronary intervention in intermediate coronary artery disease: fractional flow reserve-guided versus intravascular ultrasound-guided. JACC Cardiovasc Interv. 2010 Aug;3(8):812-7. doi: 10.1016/j.jcin.2010.04.016.
Results Reference
result
PubMed Identifier
28317458
Citation
Davies JE, Sen S, Dehbi HM, Al-Lamee R, Petraco R, Nijjer SS, Bhindi R, Lehman SJ, Walters D, Sapontis J, Janssens L, Vrints CJ, Khashaba A, Laine M, Van Belle E, Krackhardt F, Bojara W, Going O, Harle T, Indolfi C, Niccoli G, Ribichini F, Tanaka N, Yokoi H, Takashima H, Kikuta Y, Erglis A, Vinhas H, Canas Silva P, Baptista SB, Alghamdi A, Hellig F, Koo BK, Nam CW, Shin ES, Doh JH, Brugaletta S, Alegria-Barrero E, Meuwissen M, Piek JJ, van Royen N, Sezer M, Di Mario C, Gerber RT, Malik IS, Sharp ASP, Talwar S, Tang K, Samady H, Altman J, Seto AH, Singh J, Jeremias A, Matsuo H, Kharbanda RK, Patel MR, Serruys P, Escaned J. Use of the Instantaneous Wave-free Ratio or Fractional Flow Reserve in PCI. N Engl J Med. 2017 May 11;376(19):1824-1834. doi: 10.1056/NEJMoa1700445. Epub 2017 Mar 18.
Results Reference
result
PubMed Identifier
30261237
Citation
Zhang J, Gao X, Kan J, Ge Z, Han L, Lu S, Tian N, Lin S, Lu Q, Wu X, Li Q, Liu Z, Chen Y, Qian X, Wang J, Chai D, Chen C, Li X, Gogas BD, Pan T, Shan S, Ye F, Chen SL. Intravascular Ultrasound Versus Angiography-Guided Drug-Eluting Stent Implantation: The ULTIMATE Trial. J Am Coll Cardiol. 2018 Dec 18;72(24):3126-3137. doi: 10.1016/j.jacc.2018.09.013. Epub 2018 Sep 24.
Results Reference
result
PubMed Identifier
22481046
Citation
Park KW, Kang SH, Yang HM, Lee HY, Kang HJ, Cho YS, Youn TJ, Koo BK, Chae IH, Kim HS. Impact of intravascular ultrasound guidance in routine percutaneous coronary intervention for conventional lesions: data from the EXCELLENT trial. Int J Cardiol. 2013 Aug 10;167(3):721-6. doi: 10.1016/j.ijcard.2012.03.059. Epub 2012 Apr 4.
Results Reference
result
PubMed Identifier
29754669
Citation
Kang J, Koo BK, Hu X, Lee JM, Hahn JY, Yang HM, Shin ES, Nam CW, Doh JH, Lee BK, Ahn C, Wang J, Tahk SJ. Comparison of Fractional FLow Reserve And Intravascular ultrasound-guided Intervention Strategy for Clinical OUtcomes in Patients with InteRmediate Stenosis (FLAVOUR): Rationale and design of a randomized clinical trial. Am Heart J. 2018 May;199:7-12. doi: 10.1016/j.ahj.2017.11.001. Epub 2017 Nov 6.
Results Reference
result
PubMed Identifier
29891620
Citation
Garcia-Garcia HM, McFadden EP, Farb A, Mehran R, Stone GW, Spertus J, Onuma Y, Morel MA, van Es GA, Zuckerman B, Fearon WF, Taggart D, Kappetein AP, Krucoff MW, Vranckx P, Windecker S, Cutlip D, Serruys PW; Academic Research Consortium. Standardized End Point Definitions for Coronary Intervention Trials: The Academic Research Consortium-2 Consensus Document. Circulation. 2018 Jun 12;137(24):2635-2650. doi: 10.1161/CIRCULATIONAHA.117.029289.
Results Reference
result
PubMed Identifier
29778671
Citation
ISCHEMIA Trial Research Group; Maron DJ, Hochman JS, O'Brien SM, Reynolds HR, Boden WE, Stone GW, Bangalore S, Spertus JA, Mark DB, Alexander KP, Shaw L, Berger JS, Ferguson TB Jr, Williams DO, Harrington RA, Rosenberg Y. International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA) trial: Rationale and design. Am Heart J. 2018 Jul;201:124-135. doi: 10.1016/j.ahj.2018.04.011. Epub 2018 Apr 21.
Results Reference
result
PubMed Identifier
32227755
Citation
Maron DJ, Hochman JS, Reynolds HR, Bangalore S, O'Brien SM, Boden WE, Chaitman BR, Senior R, Lopez-Sendon J, Alexander KP, Lopes RD, Shaw LJ, Berger JS, Newman JD, Sidhu MS, Goodman SG, Ruzyllo W, Gosselin G, Maggioni AP, White HD, Bhargava B, Min JK, Mancini GBJ, Berman DS, Picard MH, Kwong RY, Ali ZA, Mark DB, Spertus JA, Krishnan MN, Elghamaz A, Moorthy N, Hueb WA, Demkow M, Mavromatis K, Bockeria O, Peteiro J, Miller TD, Szwed H, Doerr R, Keltai M, Selvanayagam JB, Steg PG, Held C, Kohsaka S, Mavromichalis S, Kirby R, Jeffries NO, Harrell FE Jr, Rockhold FW, Broderick S, Ferguson TB Jr, Williams DO, Harrington RA, Stone GW, Rosenberg Y; ISCHEMIA Research Group. Initial Invasive or Conservative Strategy for Stable Coronary Disease. N Engl J Med. 2020 Apr 9;382(15):1395-1407. doi: 10.1056/NEJMoa1915922. Epub 2020 Mar 30.
Results Reference
result
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Angiography-Derived FFR And IVUS for Clinical Outcomes in Patients With Coronary Artery Disease
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