International Post PCI FFR Registry
1 other identifier
observational
2,228
0 countries
N/A
Brief Summary
The prognostic factors after a percutaneous coronary intervention (PCI) have not been comprehensively investigated. The investigators sought to develop a risk model to predict future clinical events after PCI using contemporary coronary stents.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2010
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 17, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 11, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 28, 2019
CompletedFirst Submitted
Initial submission to the registry
July 3, 2019
CompletedFirst Posted
Study publicly available on registry
July 9, 2019
CompletedJuly 16, 2019
July 1, 2019
8.5 years
July 3, 2019
July 13, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Discrimination index of prediction model for target-vessel failure
A risk model for target-vessel failure, incorporating clinical, angiographic, and additional physiologic predictors, will be developed using this cohort. Target vessel failure is a composite of cardiac death, clinically-driven target vessel-related myocardial infarction, and clinically-driven target vessel revascularization. The target vessel will be defined as the treated vessel with 2nd generation DES which was assessed by post stent fractional flow reserve.
2 years after index procedure
Secondary Outcomes (1)
Independent predictors for target vessel failure
2 years after index procedure
Study Arms (1)
Post PCI state
The study population of this study underwent percutaneous coronary intervention(PCI) with 2nd generation drug-eluting stent (DES) and measured fractional flow reserve after PCI
Interventions
Eligibility Criteria
Patients who were diagnosed as obstructive coronary artery disease and treated by 2nd generation DES and measured post PCI FFR after PCI.
You may qualify if:
- Patients who underwent PCI and post-PCI FFR measurements after angiographically successful stent implantation (residual stenosis \< 20% by visual estimation)
- Patients who provided informed consent
You may not qualify if:
- Post-PCI TIMI flow of \< 3
- Depressed left ventricular systolic function (ejection fraction \< 30%)
- Culprit lesion for acute coronary syndrome
- Graft vessel
- Collateral feeder
- In-stent stenosis
- Primary myocardial or valvular heart disease
- Patients with life expectancy \< 2 years.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seoul National University Hospitallead
- The First Affiliated Hospital with Nanjing Medical Universitycollaborator
- Tsuchiura Kyodo General Hospitalcollaborator
- Keimyung University Dongsan Medical Centercollaborator
- Ulsan University Hospitalcollaborator
- Busan Veterans General Hospitalcollaborator
- Samsung Medical Centercollaborator
- Sejong General Hospitalcollaborator
- Tokyo Medical Universitycollaborator
- Gifu Heart Centercollaborator
- Japanese Red Cross Kyoto Daini Hospitalcollaborator
- Inje Universitycollaborator
Related Publications (9)
Neumann FJ, Sousa-Uva M, Ahlsson A, Alfonso F, Banning AP, Benedetto U, Byrne RA, Collet JP, Falk V, Head SJ, Juni P, Kastrati A, Koller A, Kristensen SD, Niebauer J, Richter DJ, Seferovic PM, Sibbing D, Stefanini GG, Windecker S, Yadav R, Zembala MO; ESC Scientific Document Group. 2018 ESC/EACTS Guidelines on myocardial revascularization. Eur Heart J. 2019 Jan 7;40(2):87-165. doi: 10.1093/eurheartj/ehy394. No abstract available.
PMID: 30165437BACKGROUNDFearon WF, Nishi T, De Bruyne B, Boothroyd DB, Barbato E, Tonino P, Juni P, Pijls NHJ, Hlatky MA; FAME 2 Trial Investigators. Clinical Outcomes and Cost-Effectiveness of Fractional Flow Reserve-Guided Percutaneous Coronary Intervention in Patients With Stable Coronary Artery Disease: Three-Year Follow-Up of the FAME 2 Trial (Fractional Flow Reserve Versus Angiography for Multivessel Evaluation). Circulation. 2018 Jan 30;137(5):480-487. doi: 10.1161/CIRCULATIONAHA.117.031907. Epub 2017 Nov 2.
PMID: 29097450BACKGROUNDHwang D, Lee JM, Lee HJ, Kim SH, Nam CW, Hahn JY, Shin ES, Matsuo A, Tanaka N, Matsuo H, Lee SY, Doh JH, Koo BK. Influence of target vessel on prognostic relevance of fractional flow reserve after coronary stenting. EuroIntervention. 2019 Aug 29;15(5):457-464. doi: 10.4244/EIJ-D-18-00913.
PMID: 30561367BACKGROUNDLi SJ, Ge Z, Kan J, Zhang JJ, Ye F, Kwan TW, Santoso T, Yang S, Sheiban I, Qian XS, Tian NL, Rab TS, Tao L, Chen SL. Cutoff Value and Long-Term Prediction of Clinical Events by FFR Measured Immediately After Implantation of a Drug-Eluting Stent in Patients With Coronary Artery Disease: 1- to 3-Year Results From the DKCRUSH VII Registry Study. JACC Cardiovasc Interv. 2017 May 22;10(10):986-995. doi: 10.1016/j.jcin.2017.02.012. Epub 2017 Apr 26.
PMID: 28456699BACKGROUNDRimac G, Fearon WF, De Bruyne B, Ikeno F, Matsuo H, Piroth Z, Costerousse O, Bertrand OF. Clinical value of post-percutaneous coronary intervention fractional flow reserve value: A systematic review and meta-analysis. Am Heart J. 2017 Jan;183:1-9. doi: 10.1016/j.ahj.2016.10.005. Epub 2016 Oct 11.
PMID: 27979031BACKGROUNDvan Zandvoort LJC, Masdjedi K, Witberg K, Ligthart J, Tovar Forero MN, Diletti R, Lemmert ME, Wilschut J, de Jaegere PPT, Boersma E, Zijlstra F, Van Mieghem NM, Daemen J. Explanation of Postprocedural Fractional Flow Reserve Below 0.85. Circ Cardiovasc Interv. 2019 Feb;12(2):e007030. doi: 10.1161/CIRCINTERVENTIONS.118.007030.
PMID: 30732469BACKGROUNDZhang J, Hwang D, Yang S, Kim CH, Lee JM, Nam CW, Shin ES, Doh JH, Hoshino M, Hamaya R, Kanaji Y, Murai T, Zhang JJ, Ye F, Li X, Ge Z, Chen SL, Kakuta T, Koo BK. Differential Prognostic Implications of Pre- and Post-Stent Fractional Flow Reserve in Patients Undergoing Percutaneous Coronary Intervention. Korean Circ J. 2022 Jan;52(1):47-59. doi: 10.4070/kcj.2021.0128. Epub 2021 Sep 24.
PMID: 34877828DERIVEDLee JM, Hwang D, Choi KH, Lee HJ, Song YB, Cho YK, Nam CW, Hahn JY, Shin ES, Doh JH, Hoshino M, Hamaya R, Kanaji Y, Murai T, Zhang JJ, Ye F, Li X, Ge Z, Chen SL, Kakuta T, Koo BK. Prognostic Impact of Residual Anatomic Disease Burden After Functionally Complete Revascularization. Circ Cardiovasc Interv. 2020 Sep;13(9):e009232. doi: 10.1161/CIRCINTERVENTIONS.120.009232. Epub 2020 Sep 8.
PMID: 32895005DERIVEDHwang D, Lee JM, Yang S, Chang M, Zhang J, Choi KH, Kim CH, Nam CW, Shin ES, Kwak JJ, Doh JH, Hoshino M, Hamaya R, Kanaji Y, Murai T, Zhang JJ, Ye F, Li X, Ge Z, Chen SL, Kakuta T, Koo BK. Role of Post-Stent Physiological Assessment in a Risk Prediction Model After Coronary Stent Implantation. JACC Cardiovasc Interv. 2020 Jul 27;13(14):1639-1650. doi: 10.1016/j.jcin.2020.04.041.
PMID: 32703590DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bon-Kwon Koo, MD, PhD
Seoul National University Hospital
- PRINCIPAL INVESTIGATOR
Joon Hyung Doh, MD, PhD
Inje University
- PRINCIPAL INVESTIGATOR
Shao-Liang Chen, MD
Nanjing First Hospital, Nanjing Medical University
- PRINCIPAL INVESTIGATOR
Tsunekazu Kakuta, MD, PhD
Tsuchiura Kyodo General Hospital
- PRINCIPAL INVESTIGATOR
Joo Myung Lee, MD, PhD
Samsung Medical Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 2 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 3, 2019
First Posted
July 9, 2019
Study Start
August 17, 2010
Primary Completion
February 11, 2019
Study Completion
March 28, 2019
Last Updated
July 16, 2019
Record last verified: 2019-07