Coronary Artery DiseasePRIME-FFRNCT05250557
Prognostic Impact of Lesion-specific Hemodynamic Index in Patients With Coronary Artery Disease
An observational study of Coronary Artery Disease, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The investigators aim to investigate the additive prognostic value of lesion-specific hemodynamic index such as ΔFFR, non-hyperemic pressure ratio such as RFR, over % diameter stenosis and FFR according to treatment strategy, and to find the prognostic implications of post-PCI FFR after adjustment of various clinical… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Fractional flow reserve
- How many people
- 2,429 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Aug 2021to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with suspected coronary artery disease who undergo FFR measurement and pullback tracing will be included. If the patients receive PCI after FFR measurement, those with available both preprocedural and postprocedural FFR measurement will be included.
Who may be able to join
- Age ≥20 years
- All comers who underwent successful FFR measurement and pullback tracing
Who cannot join
- Chronic renal failure (estimated glomerular filtration rate <30)
- ST-elevation myocardial infarction within 72 hours or previous coronary artery bypass graft surgery history
- Primary myocardial or valvular disease
- Left ventricular ejection fraction < 30%
- Hemodynamically unstable clinical conditions
- Life expectancy < 2 years
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 110-744
Bon-Kwon Koo, MD, PhD, +82-2-2072-2062, bkkoo@snu.ac.kr
Seokhun Yang, MD, +82-2-2072-2062, newturnz7@gmail.com
About this study
Official title: Prognostic Impact of Lesion-specific Hemodynamic Index and Disease Characteristics in Patients With Coronary Artery Disease Assessed by Fractional Flow Reserve
The investigators aim to investigate the additive prognostic value of lesion-specific hemodynamic index such as ΔFFR, non-hyperemic pressure ratio such as RFR, over % diameter stenosis and FFR according to treatment strategy, and to find the prognostic implications of post-PCI FFR after adjustment of various clinical and disease characteristics, and to construct a comprehensive risk prediction model for post-PCI outcomes.
Read the detailed description
Fractional flow reserve (FFR)-based revascularization is the currently best practice recommended by guidelines. In addition to the use of coronary physiological indices as a vessel-specific metric, recent studies suggested the clinical importance of local hemodynamics in prediction of risk for target vessel failure or acute coronary syndrome in patients with coronary artery disease. In patients who receive percutaneous coronary intervention (PCI), the absolute value and pattern of FFR change after stenting are helpful in defining the additional target for PCI and risk stratification after PCI. However, there has been no prospective study that proved the benefit of change in FFR across the lesion (ΔFFR) in daily clinical practice, and FFR usage after stenting is much less than before stenting. Accordingly, we will prove the benefit of ΔFFR in addition to FFR, prognostic implications of combining RFR and FFR, and the comprehensive risk model with post-PCI FFR, clinical and disease characteristics in a prospective study, to maximize the benefit of invasive physiologic assessment.
- Conditions
- Coronary Artery Disease
- Being tested
- Fractional flow reserve
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fractional flow reserveDiagnostic test
Physiologic assessment includes Δ FFR (lesion-specific) and FFR (vessel-specific) measurement. Δ FFR is defined as a pressure step up across the lesion. Coronary angiography and physiologic assessment will be analyzed by an independent core laboratory (Seoul National University Hospital, Clinical Trial Center, Seoul, South Korea).
| Study group | Role | What they receive |
|---|---|---|
| Deferral of PCI group | Patients who undergo successful FFR pullback tracing and have a vessel determined to defer revascularization after FFR measurement will be included. Receives: Diagnostic Test: Fractional flow reserve | |
| PCI group | Patients who undergo successful FFR pullback tracing and have a vessel that undergo stent implantation and FFR measurement both before and after revascularization (pre-PCI FFR and post-PCI FFR) will be included. Receives: Diagnostic Test: Fractional flow reserve |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse cardiovascular event according to ΔFFR (Deferral of PCI group)
Composite of 2-year target vessel revascularization, target vessel myocardial infarction, and cardiac death
Measured: Upto 2 years after index procedure
Adverse cardiovascular event according to post-PCI FFR (PCI group)
Composite of 2-year target vessel revascularization, target vessel myocardial infarction, and cardiac death
Measured: Upto 2 years after index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2022
- Study start1 Aug 2021
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,429 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Keimyung University Dongsan Medical Center, Inje University, Ulsan University Hospital, Dong-A University Hospital, Gyeongsang National University Hospital, KangWon National University Hospital, Wonju Severance Christian Hospital, Severance Hospital, Seoul National University Bundang Hospital, Tsuchiura Kyodo General Hospital
- Responsible party
- Principal investigator, Bon-Kwon Koo, Seoul National University Hospital
- Investigators
- Bon-Kwon Koo, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05250557
- Sponsor's protocol ID
- H-2107-230-1240
- Acronym
- PRIME-FFR
- Status last verified
- Feb 2022
- First submitted
- 10 Feb 2022
- Last updated
- 22 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The sharing plan will be decided by the study committee.
Publications
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.
PubMed 30165437Park JB, Choi G, Chun EJ, Kim HJ, Park J, Jung JH, Lee MH, Otake H, Doh JH, Nam CW, Shin ES, De Bruyne B, Taylor CA, Koo BK. Computational fluid dynamic measures of wall shear stress are related to coronary lesion characteristics. Heart. 2016 Oct 15;102(20):1655-61. doi: 10.1136/heartjnl-2016-309299. Epub 2016 Jun 14.
PubMed 27302987Choi G, Lee JM, Kim HJ, Park JB, Sankaran S, Otake H, Doh JH, Nam CW, Shin ES, Taylor CA, Koo BK. Coronary Artery Axial Plaque Stress and its Relationship With Lesion Geometry: Application of Computational Fluid Dynamics to Coronary CT Angiography. JACC Cardiovasc Imaging. 2015 Oct;8(10):1156-1166. doi: 10.1016/j.jcmg.2015.04.024. Epub 2015 Sep 9.
PubMed 26363834Lee JM, Choi G, Koo BK, Hwang D, Park J, Zhang J, Kim KJ, Tong Y, Kim HJ, Grady L, Doh JH, Nam CW, Shin ES, Cho YS, Choi SY, Chun EJ, Choi JH, Norgaard BL, Christiansen EH, Niemen K, Otake H, Penicka M, de Bruyne B, Kubo T, Akasaka T, Narula J, Douglas PS, Taylor CA, Kim HS. Identification of High-Risk Plaques Destined to Cause Acute Coronary Syndrome Using Coronary Computed Tomographic Angiography and Computational Fluid Dynamics. JACC Cardiovasc Imaging. 2019 Jun;12(6):1032-1043. doi: 10.1016/j.jcmg.2018.01.023. Epub 2018 Mar 14.
PubMed 29550316Hwang 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.
PubMed 32703590Rimac 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.
PubMed 27979031Hwang 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.
PubMed 30561367Li 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.
PubMed 28456699Hakeem A, Uretsky BF. Role of Postintervention Fractional Flow Reserve to Improve Procedural and Clinical Outcomes. Circulation. 2019 Jan 29;139(5):694-706. doi: 10.1161/CIRCULATIONAHA.118.035837.
PubMed 30689413Lee JM, Hwang D, Choi KH, Rhee TM, Park J, Kim HY, Jung HW, Hwang JW, Lee HJ, Jang HJ, Kim SH, Song YB, Cho YK, Nam CW, Hahn JY, Shin ES, Kawase Y, Matsuo A, Tanaka N, Doh JH, Koo BK, Matsuo H. Prognostic Implications of Relative Increase and Final Fractional Flow Reserve in Patients With Stent Implantation. JACC Cardiovasc Interv. 2018 Oct 22;11(20):2099-2109. doi: 10.1016/j.jcin.2018.07.031.
PubMed 30336814Johnson NP, Toth GG, Lai D, Zhu H, Acar G, Agostoni P, Appelman Y, Arslan F, Barbato E, Chen SL, Di Serafino L, Dominguez-Franco AJ, Dupouy P, Esen AM, Esen OB, Hamilos M, Iwasaki K, Jensen LO, Jimenez-Navarro MF, Katritsis DG, Kocaman SA, Koo BK, Lopez-Palop R, Lorin JD, Miller LH, Muller O, Nam CW, Oud N, Puymirat E, Rieber J, Rioufol G, Rodes-Cabau J, Sedlis SP, Takeishi Y, Tonino PA, Van Belle E, Verna E, Werner GS, Fearon WF, Pijls NH, De Bruyne B, Gould KL. Prognostic value of fractional flow reserve: linking physiologic severity to clinical outcomes. J Am Coll Cardiol. 2014 Oct 21;64(16):1641-54. doi: 10.1016/j.jacc.2014.07.973.
PubMed 25323250Schoenfeld DA. Sample-size formula for the proportional-hazards regression model. Biometrics. 1983 Jun;39(2):499-503.
PubMed 6354290Lee JM, Lee SH, Hwang D, Rhee TM, Choi KH, Kim J, Park J, Kim HY, Jung HW, Cho YK, Yoon HJ, Song YB, Hahn JY, Nam CW, Shin ES, Doh JH, Hur SH, Koo BK. Long-Term Clinical Outcomes of Nonhyperemic Pressure Ratios: Resting Full-Cycle Ratio, Diastolic Pressure Ratio, and Instantaneous Wave-Free Ratio. J Am Heart Assoc. 2020 Sep 15;9(18):e016818. doi: 10.1161/JAHA.120.016818. Epub 2020 Sep 11.
PubMed 32914672Hsieh FY, Lavori PW. Sample-size calculations for the Cox proportional hazards regression model with nonbinary covariates. Control Clin Trials. 2000 Dec;21(6):552-60. doi: 10.1016/s0197-2456(00)00104-5.
PubMed 11146149
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Impact of Lesion-specific Hemodynamic Index and Disease Characteristics in Patients With Coronary Artery Disease Assessed by Fractional Flow Reserve
- ClinicalTrials.gov ID
- NCT05250557
- Acronym / sponsor ID
- PRIME-FFR / H-2107-230-1240
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,429 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Keimyung University Dongsan Medical Center, Inje University, Ulsan University Hospital, Dong-A University Hospital, Gyeongsang National University Hospital, KangWon National University Hospital, Wonju Severance Christian Hospital, Severance Hospital, Seoul National University Bundang Hospital, Tsuchiura Kyodo General Hospital
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 22 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators aim to investigate the additive prognostic value of lesion-specific hemodynamic index such as ΔFFR, non-hyperemic pressure ratio such as RFR, over % diameter stenosis and FFR according to treatment strategy, and to find the prognostic implications of post-PCI FFR after adjustment of various clinical and disease characteristics, and to construct a comprehensive risk prediction model for post-PCI outcomes.
Detailed description
Fractional flow reserve (FFR)-based revascularization is the currently best practice recommended by guidelines. In addition to the use of coronary physiological indices as a vessel-specific metric, recent studies suggested the clinical importance of local hemodynamics in prediction of risk for target vessel failure or acute coronary syndrome in patients with coronary artery disease. In patients who receive percutaneous coronary intervention (PCI), the absolute value and pattern of FFR change after stenting are helpful in defining the additional target for PCI and risk stratification after PCI. However, there has been no prospective study that proved the benefit of change in FFR across the lesion (ΔFFR) in daily clinical practice, and FFR usage after stenting is much less than before stenting. Accordingly, we will prove the benefit of ΔFFR in addition to FFR, prognostic implications of combining RFR and FFR, and the comprehensive risk model with post-PCI FFR, clinical and disease characteristics in a prospective study, to maximize the benefit of invasive physiologic assessment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Deferral of PCI group | – | Diagnostic Test: Fractional flow reservePatients who undergo successful FFR pullback tracing and have a vessel determined to defer revascularization after FFR measurement will be included. |
| PCI group | – | Diagnostic Test: Fractional flow reservePatients who undergo successful FFR pullback tracing and have a vessel that undergo stent implantation and FFR measurement both before and after revascularization (pre-PCI FFR and post-PCI FFR) will be included. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with suspected coronary artery disease who undergo FFR measurement and pullback tracing will be included. If the patients receive PCI after FFR measurement, those with available both preprocedural and postprocedural FFR measurement will be included.
Key inclusion criteria (2 listed)
- Age ≥20 years
- All comers who underwent successful FFR measurement and pullback tracing
Key exclusion criteria (6 listed)
- Chronic renal failure (estimated glomerular filtration rate <30)
- ST-elevation myocardial infarction within 72 hours or previous coronary artery bypass graft surgery history
- Primary myocardial or valvular disease
- Left ventricular ejection fraction < 30%
- Hemodynamically unstable clinical conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fractional flow reservePhysiologic assessment includes Δ FFR (lesion-specific) and FFR (vessel-specific) measurement. Δ FFR is defined as a pressure step up across the lesion. Coronary angiography and physiologic assessment will be analyzed by an independent core laboratory (Seoul National University Hospital, Clinical Trial Center, Seoul, South Korea). | Diagnostic test | Deferral of PCI group, PCI group |
Primary outcome
Adverse cardiovascular event according to ΔFFR (Deferral of PCI group)
Time frame: Upto 2 years after index procedure
Composite of 2-year target vessel revascularization, target vessel myocardial infarction, and cardiac death
Adverse cardiovascular event according to post-PCI FFR (PCI group)
Time frame: Upto 2 years after index procedure
Composite of 2-year target vessel revascularization, target vessel myocardial infarction, and cardiac death
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2022.
- Background: PubMed 30165437Neumann 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.
- Background: PubMed 27302987Park JB, Choi G, Chun EJ, Kim HJ, Park J, Jung JH, Lee MH, Otake H, Doh JH, Nam CW, Shin ES, De Bruyne B, Taylor CA, Koo BK. Computational fluid dynamic measures of wall shear stress are related to coronary lesion characteristics. Heart. 2016 Oct 15;102(20):1655-61. doi: 10.1136/heartjnl-2016-309299. Epub 2016 Jun 14.
- Background: PubMed 26363834Choi G, Lee JM, Kim HJ, Park JB, Sankaran S, Otake H, Doh JH, Nam CW, Shin ES, Taylor CA, Koo BK. Coronary Artery Axial Plaque Stress and its Relationship With Lesion Geometry: Application of Computational Fluid Dynamics to Coronary CT Angiography. JACC Cardiovasc Imaging. 2015 Oct;8(10):1156-1166. doi: 10.1016/j.jcmg.2015.04.024. Epub 2015 Sep 9.
- Background: PubMed 29550316Lee JM, Choi G, Koo BK, Hwang D, Park J, Zhang J, Kim KJ, Tong Y, Kim HJ, Grady L, Doh JH, Nam CW, Shin ES, Cho YS, Choi SY, Chun EJ, Choi JH, Norgaard BL, Christiansen EH, Niemen K, Otake H, Penicka M, de Bruyne B, Kubo T, Akasaka T, Narula J, Douglas PS, Taylor CA, Kim HS. Identification of High-Risk Plaques Destined to Cause Acute Coronary Syndrome Using Coronary Computed Tomographic Angiography and Computational Fluid Dynamics. JACC Cardiovasc Imaging. 2019 Jun;12(6):1032-1043. doi: 10.1016/j.jcmg.2018.01.023. Epub 2018 Mar 14.
- Background: PubMed 32703590Hwang 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.
- Background: PubMed 27979031Rimac 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.
- Background: PubMed 30561367Hwang 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.
- Background: PubMed 28456699Li 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.
- Background: PubMed 30689413Hakeem A, Uretsky BF. Role of Postintervention Fractional Flow Reserve to Improve Procedural and Clinical Outcomes. Circulation. 2019 Jan 29;139(5):694-706. doi: 10.1161/CIRCULATIONAHA.118.035837.
- Background: PubMed 30336814Lee JM, Hwang D, Choi KH, Rhee TM, Park J, Kim HY, Jung HW, Hwang JW, Lee HJ, Jang HJ, Kim SH, Song YB, Cho YK, Nam CW, Hahn JY, Shin ES, Kawase Y, Matsuo A, Tanaka N, Doh JH, Koo BK, Matsuo H. Prognostic Implications of Relative Increase and Final Fractional Flow Reserve in Patients With Stent Implantation. JACC Cardiovasc Interv. 2018 Oct 22;11(20):2099-2109. doi: 10.1016/j.jcin.2018.07.031.
- Background: PubMed 25323250Johnson NP, Toth GG, Lai D, Zhu H, Acar G, Agostoni P, Appelman Y, Arslan F, Barbato E, Chen SL, Di Serafino L, Dominguez-Franco AJ, Dupouy P, Esen AM, Esen OB, Hamilos M, Iwasaki K, Jensen LO, Jimenez-Navarro MF, Katritsis DG, Kocaman SA, Koo BK, Lopez-Palop R, Lorin JD, Miller LH, Muller O, Nam CW, Oud N, Puymirat E, Rieber J, Rioufol G, Rodes-Cabau J, Sedlis SP, Takeishi Y, Tonino PA, Van Belle E, Verna E, Werner GS, Fearon WF, Pijls NH, De Bruyne B, Gould KL. Prognostic value of fractional flow reserve: linking physiologic severity to clinical outcomes. J Am Coll Cardiol. 2014 Oct 21;64(16):1641-54. doi: 10.1016/j.jacc.2014.07.973.
- Background: PubMed 6354290Schoenfeld DA. Sample-size formula for the proportional-hazards regression model. Biometrics. 1983 Jun;39(2):499-503.
- Individual participant dataSharing planned: Undecided. The sharing plan will be decided by the study committee.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bon-Kwon Koo, MD, PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bon-Kwon Koo, MD, PhD (+82-2-2072-2062, bkkoo@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse cardiovascular event according to ΔFFR (Deferral of PCI group) (time frame: Upto 2 years after index procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05250557, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2022.