Myocardial Infarction, AcuteNCT04968808
Timing of FFR-guided PCI for Non-IRA in NSTEMI and MVD (OPTION-NSTEMI)
A study testing Staged in-hospital complete revascularization and Immediate complete revascularization in people with Myocardial Infarction, Acute and Multi-Vessel Coronary Artery Stenosis, run by Chonnam National University Hospital at 1 site in South Korea.
Trial summary
Many patients with non-ST-segment elevation myocardial infarction (NSTEMI) have multivessel coronary artery disease (MVD), which is associated with poor clinical outcomes. However, there have been few studies regarding revascularization strategy in patients with NSTEMI and MVD. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Myocardial Infarction, Acute, Multi-Vessel Coronary Artery Stenosis, Multi Vessel Coronary Artery Disease
- What is being tested?
- Staged in-hospital complete revascularization and Immediate complete revascularization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,014 participants
- Where
- 1 siteSouth Korea
- Study dates
- 6 Sep 2021to 31 Aug 2032
- Phase
- Interventional
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 19 years old
- Non-ST-segment elevation myocardial infarction
- Angina pectoris or equivalent ischemic chest discomfort with at least 1 of 3 features and,
- occurs at rest, usually lasting > 10 minutes
- severe and new onset (within the prior 4-6 weeks)
- crescendo pattern
Show all 12Show fewer
- Elevated cardiac biomarkers and,
- ≥ 99% value of high-sensitivity cardiac troponin
- No ST-segment elevation ≥ 0.1 mV in ≥ 2 contiguous leads or newly developed left bundle branch block on 12-lead electrocardiogram
- PCI within 72 hours after symptom development
- Multivessel disease: Non-IRA with at least 2.5 mm diameter and 50% diameter stenosis by visual estimation
- Patient's or protector's agreement about study design and the risk of PCI
Who cannot join
- Cardiogenic shock at initial presentation or after treatment of IRA
- TIMI flow at non-IRA ≤ 2
- Severe procedural complications (e.g. persistent no-reflow phenomenon, coronary artery perforation) which restricts study enrollment by operators' decision
- Non-IRA lesion not suitable for PCI treatment by operators' decision
- Chronic total occlusion at non-IRA
- History of anaphylaxis to contrast agent
Show all 11Show fewer
- Pregnancy and lactation
- Life expectancy < 1-year
- Severe valvular disease
- History of CABG, or planned CABG
- Fibrinolysis before admission
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
Chonnam National University Hospital
Gwangju
Min Chul Kim, MD
About this study
Official title: OPtimal TIming of Fractional Flow Reserve-Guided Complete RevascularizatiON in Non-ST-Segment Elevation Myocardial Infarction (OPTION-NSTEMI)
Many patients with non-ST-segment elevation myocardial infarction (NSTEMI) have multivessel coronary artery disease (MVD), which is associated with poor clinical outcomes. However, there have been few studies regarding revascularization strategy in patients with NSTEMI and MVD. Therefore, we planned to perform prospective, open-label, randomized trial to evaluate the efficacy and safety of immediate complete revascularization (percutaneous coronary intervention [PCI] for both infarct-related artery [IRA] and non-IRA during index PCI) compared to staged PCI strategy of non-IRA (PCI for IRA followed by non-IRA PCI after several days). PCI procedure at non-IRA with diameter stenosis between 50 and 69% should be conducted with the aid of fractional flow reserve (FFR), and non-IRA with diameter stenosis ≥ 70% will be revascularized without FFR.
Read the detailed description
Many patients with non-ST-segment elevation myocardial infarction (NSTEMI) have multivessel coronary artery disease (MVD), which is associated with poor clinical outcomes. In cases of hemodynamically stable ST-segment elevation myocardial infarction (STEMI) and MVD, many studies demonstrated the superiority of complete revascularization (CR) by both one-stage and multistage procedures compared to culprit-only revascularization (COR). The 2017 European Society of Cardiology (ESC) guidelines for STEMI recommend routine revascularization for non infarct-related artery (IRA) lesions before hospital discharge in patients without cardiogenic shock.
However, there have been few studies regarding revascularization strategy in patients with NSTEMI and MVD. Only one randomized controlled trial, the SMILE trial (J Am Coll Cardiol 2016;67:264-72), compared one-stage and multi-stage multivessel revascularization (MVR) in these patients. Although the results of most studies analyzing interventional strategies in patients with NSTEMI and MVD showed superior results of MVR compared to COR, they did not provide information about staged revascularization. One-stage MVR was associated with better clinical outcomes compared to multi-stage MVR in the SMILE trial, while one-stage and multi-stage MVR had similar incidences of adverse outcomes in large registry data. Although the 2018 ESC/European Association for Cardio-Thoracic Surgery (EACTS) guidelines for myocardial revascularization recommend complete one-stage revascularization in NSTEMI and MVD, it emphasizes individualization based on clinical status and comorbidities, as well as disease severity. In 2020 ESC guidelines for non-ST-segment elevation acute coronary syndrome, this strategy is maintained. CR during index percutaneous coronary intervention (PCI) is recommended in NSTEMI patients with MVD (class IIb, level B).
Whether to revascularize non-IRA using angiography or fractional flow reserve (FFR) is also problematic. FFR is a useful tool for assessing hemodynamic significance of non-IRA during both acute and subacute stage, and FFR-guided PCI for non-IRA lesion is recommended during index PCI (class IIb, level B). In the SMILE trial, a 25.8% of study patients received FFR-guided PCI for non-IRA. Although FFR is a well-known tool to evaluate significant ischemia of moderate stenosis, the most studies regarding FFR enrolled patients without acute myocardial infarction (AMI).
However, the recommendations in current guidelines, which recommends CR during index PCI, is not sufficiently powered to assess differences in clinical outcomes between interventional strategy. There are also few studies regarding this issue, and discrepancy in clinical outcomes between randomized trial and observational studies. Furthermore, FFR-guided PCI for non-IRA is not mandatory in these studies.
Therefore, we planned to perform prospective, open-label, randomized trial to evaluate the efficacy and safety of immediate complete revascularization (PCI for both IRA and non-IRA during index PCI) compared to staged PCI strategy of non-IRA (PCI for IRA followed by non-IRA PCI after several days). PCI procedure at non-IRA with diameter stenosis between 50 and 69% should be conducted with the aid of FFR, and non-IRA with diameter stenosis ≥ 70% will be revascularized without FFR.
- Conditions
- Myocardial Infarction, Acute, Multi-Vessel Coronary Artery Stenosis, Multi Vessel Coronary Artery Disease
- Being tested
- Staged in-hospital complete revascularization, Immediate complete revascularization
- Keywords
- Non-ST-Segment Elevation Myocardial Infarction, Multi-Vessel Coronary Artery Disease, Multi-Vessel Coronary Artery Stenosis, Culprit-Only, Multi-Vessel Percutaneous Coronary Intervention, Percutaneous Coronary Intervention, Complete Revascularization, Timing, Staged Percutaneous Coronary Intervention, Fractional Flow Reserve
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Staged in-hospital complete revascularizationProcedure or surgery
Patients with non-ST-segment elevation myocardial infarction and multivessel disease will be randomized after percutaneous coronary intervention (PCI) for infarct-related artery (IRA). All patients will be randomized to immediate complete revascularization group or staged revascularization group by 1:1 fashion. Staged in-hospital complete revascularization group will receive staged PCI for non-IRA in other day (during hospitalization) after PCI for IRA. Non-IRA lesion which have equal or more than 70% diameter stenosis by visual estimation will be revascularized without fractional flow reserve (FFR) evaluation. Non-IRA lesion with diameter stenosis 50-69% by visual estimation will be evaluated using FFR device. In case of FFR value more than 0.8, non-IRA lesion wll be deferred without PCI. If FFR value was equal or less than 0.8, non-IRA lesion will be revascularized.
Immediate complete revascularizationProcedure or surgery
Patients with non-ST-segment elevation myocardial infarction and multivessel disease will be randomized after percutaneous coronary intervention (PCI) for infarct-related artery (IRA). All patients will be randomized to immediate complete revascularization group or staged revascularization group by 1:1 fashion. Immediate complete revascularization group will receive simultaneous PCI for both IRA and non-IRA during index PCI. Non-IRA lesion which have equal or more than 70% diameter stenosis by visual estimation will be revascularized without fractional flow reserve (FFR) evaluation. Non-IRA lesion with diameter stenosis 50-69% by visual estimation will be evaluated using FFR device. In case of FFR value more than 0.8, non-IRA lesion wll be deferred without PCI. If FFR value was equal or less than 0.8, non-IRA lesion will be revascularized.
| Study group | Role | What they receive |
|---|---|---|
| Staged in-hospital CR (complete revascularization) | Active comparator | Non-infarct related artery (IRA) will be revascularized in other day (during hospitalization) after percutaneous coronary intervention (PCI) for IRA. Non-IRA lesion which have equal or more than 70% diameter stenosis by visual estimation will be revascularized without fractional flow reserve (FFR) evaluation. Non-IRA lesion with diameter stenosis 50-69% by visual estimation will be evaluated using FFR device. In case of FFR value more than 0.8, non-IRA lesion wll be deferred without PCI. If FFR value was equal or less than 0.8, non-IRA lesion will be revascularized. Receives: Procedure: Staged in-hospital complete revascularization |
| Immediate CR (complete revascularization) | Experimental | Non-infarct related artery (IRA) will be revascularized immediately after percutaneous coronary intervention (PCI) for IRA (during index PCI). Non-IRA lesion which have equal or more than 70% diameter stenosis by visual estimation will be revascularized without fractional flow reserve (FFR) evaluation. Non-IRA lesion with diameter stenosis 50-69% by visual estimation will be evaluated using FFR device. In case of FFR value more than 0.8, non-IRA lesion wll be deferred without PCI. If FFR value was equal or less than 0.8, non-IRA lesion will be revascularized. Receives: Procedure: Immediate complete revascularization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative incidence rate of all-cause death, non-fatal myocardial infarction, or all unplanned revascularization
Composite endpoint of all-cause death, non-fatal myocardial infarction, or all unplanned revascularization at 1 year from baseline
Measured: Up to 12 months
Secondary outcomes (15)
Rate of contrast-induced nephropathy
Rate of contrast-induced nephropathy during initial hospitalization
Measured: Up to 12 months
Cumulative incidence rate of all unplanned revascularization
Cumulative incidence rate of all unplanned revascularization at each visit
Measured: Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Cumulative incidence rate of target-lesion revascularization
Cumulative incidence rate of target-lesion revascularization at each visit
Measured: Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Cumulative incidence rate of target-vessel revascularization
Cumulative incidence rate of target-vessel revascularization at each visit
Measured: Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Cumulative incidence rate of non-target vessel revascularization
Cumulative incidence rate of non-target vessel revascularization at each visit
Measured: Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Cumulative incidence rate of all-cause death
Cumulative incidence rate of all-cause death at each visit
Measured: Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Cumulative incidence rate of cardiac death
Cumulative incidence rate of cardiac death at each visit
Measured: Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Cumulative incidence rate of non-cardiac death
Cumulative incidence rate of non-cardiac death at each visit
Measured: Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Cumulative incidence rate of non-fatal myocardial infarction
Cumulative incidence rate of non-fatal myocardial infarction at each visit
Measured: Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Cumulative incidence rate of hospitalization for unstable angina
Cumulative incidence rate of hospitalization for unstable angina at each visit
Measured: Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Cumulative incidence rate of hospitalization for heart failure
Cumulative incidence rate of hospitalization for heart failure at each visit
Measured: Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Cumulative incidence rate of definite or probable stent thrombosis
Cumulative incidence rate of definite or probable stent thrombosis at each visit
Measured: Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Cumulative incidence rate of ischemic and hemorrhagic stroke
Cumulative incidence rate of ischemic and hemorrhagic stroke at each visit
Measured: Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Cumulative incidence rate of major bleeding (BARC [Bleeding Academic Research Consortium] definitions type 3 or 5)
Cumulative incidence rate of major bleeding (BARC [Bleeding Academic Research Consortium] definitions type 3 or 5) at each visit
Measured: Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Cumulative incidence rate of all-cause death, non-fatal myocardial infarction, or all unplanned revascularization
Composite endpoint of all-cause death, non-fatal myocardial infarction, or all unplanned revascularization at each visit
Measured: Index admission, 1 month, 6 months, 24 months, 36 months, 48 months, 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2021
- Study start6 Sep 2021
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Aug 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial Infarction, AcuteStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,014 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chonnam National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Min Chul Kim, Chonnam National University Hospital
- Investigators
- Min Chul Kim, MD, Principal investigator, Chonnam National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04968808
- Sponsor's protocol ID
- CNUH-2021-223
- Status last verified
- Jul 2026
- First submitted
- 9 Jul 2021
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OPtimal TIming of Fractional Flow Reserve-Guided Complete RevascularizatiON in Non-ST-Segment Elevation Myocardial Infarction (OPTION-NSTEMI)
- ClinicalTrials.gov ID
- NCT04968808
- Acronym / sponsor ID
- CNUH-2021-223
- Conditions
- Myocardial Infarction, Acute, Multi-Vessel Coronary Artery Stenosis, Multi Vessel Coronary Artery Disease
- Keywords
- Non-ST-Segment Elevation Myocardial Infarction, Multi-Vessel Coronary Artery Disease, Multi-Vessel Coronary Artery Stenosis, Culprit-Only, Multi-Vessel Percutaneous Coronary Intervention, Percutaneous Coronary Intervention, Complete Revascularization, Timing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,014 participants (estimated)
- Lead sponsor
- Chonnam National University HospitalUniversity, hospital or other
- Study start
- 6 Sep 2021 (actual)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Aug 2032 (estimated)
- First posted
- 20 Jul 2021 (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.
Many patients with non-ST-segment elevation myocardial infarction (NSTEMI) have multivessel coronary artery disease (MVD), which is associated with poor clinical outcomes. However, there have been few studies regarding revascularization strategy in patients with NSTEMI and MVD. Therefore, we planned to perform prospective, open-label, randomized trial to evaluate the efficacy and safety of immediate complete revascularization (percutaneous coronary intervention [PCI] for both infarct-related artery [IRA] and non-IRA during index PCI) compared to staged PCI strategy of non-IRA (PCI for IRA followed by non-IRA PCI after several days). PCI procedure at non-IRA with diameter stenosis between 50 and 69% should be conducted with the aid of fractional flow reserve (FFR), and non-IRA with diameter stenosis ≥ 70% will be revascularized without FFR.
Detailed description
Many patients with non-ST-segment elevation myocardial infarction (NSTEMI) have multivessel coronary artery disease (MVD), which is associated with poor clinical outcomes. In cases of hemodynamically stable ST-segment elevation myocardial infarction (STEMI) and MVD, many studies demonstrated the superiority of complete revascularization (CR) by both one-stage and multistage procedures compared to culprit-only revascularization (COR). The 2017 European Society of Cardiology (ESC) guidelines for STEMI recommend routine revascularization for non infarct-related artery (IRA) lesions before hospital discharge in patients without cardiogenic shock.
However, there have been few studies regarding revascularization strategy in patients with NSTEMI and MVD. Only one randomized controlled trial, the SMILE trial (J Am Coll Cardiol 2016;67:264-72), compared one-stage and multi-stage multivessel revascularization (MVR) in these patients. Although the results of most studies analyzing interventional strategies in patients with NSTEMI and MVD showed superior results of MVR compared to COR, they did not provide information about staged revascularization. One-stage MVR was associated with better clinical outcomes compared to multi-stage MVR in the SMILE trial, while one-stage and multi-stage MVR had similar incidences of adverse outcomes in large registry data. Although the 2018 ESC/European Association for Cardio-Thoracic Surgery (EACTS) guidelines for myocardial revascularization recommend complete one-stage revascularization in NSTEMI and MVD, it emphasizes individualization based on clinical status and comorbidities, as well as disease severity. In 2020 ESC guidelines for non-ST-segment elevation acute coronary syndrome, this strategy is maintained. CR during index percutaneous coronary intervention (PCI) is recommended in NSTEMI patients with MVD (class IIb, level B).
Whether to revascularize non-IRA using angiography or fractional flow reserve (FFR) is also problematic. FFR is a useful tool for assessing hemodynamic significance of non-IRA during both acute and subacute stage, and FFR-guided PCI for non-IRA lesion is recommended during index PCI (class IIb, level B). In the SMILE trial, a 25.8% of study patients received FFR-guided PCI for non-IRA. Although FFR is a well-known tool to evaluate significant ischemia of moderate stenosis, the most studies regarding FFR enrolled patients without acute myocardial infarction (AMI).
However, the recommendations in current guidelines, which recommends CR during index PCI, is not sufficiently powered to assess differences in clinical outcomes between interventional strategy. There are also few studies regarding this issue, and discrepancy in clinical outcomes between randomized trial and observational studies. Furthermore, FFR-guided PCI for non-IRA is not mandatory in these studies.
Therefore, we planned to perform prospective, open-label, randomized trial to evaluate the efficacy and safety of immediate complete revascularization (PCI for both IRA and non-IRA during index PCI) compared to staged PCI strategy of non-IRA (PCI for IRA followed by non-IRA PCI after several days). PCI procedure at non-IRA with diameter stenosis between 50 and 69% should be conducted with the aid of FFR, and non-IRA with diameter stenosis ≥ 70% will be revascularized without FFR.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Staged in-hospital CR (complete revascularization) | Active comparator | Procedure: Staged in-hospital complete revascularizationNon-infarct related artery (IRA) will be revascularized in other day (during hospitalization) after percutaneous coronary intervention (PCI) for IRA. Non-IRA lesion which have equal or more than 70% diameter stenosis by visual estimation will be revascularized without fractional flow reserve (FFR) evaluation. Non-IRA lesion with diameter stenosis 50-69% by visual estimation will be evaluated using FFR device. In case of FFR value more than 0.8, non-IRA lesion wll be deferred without PCI. If FFR value was equal or less than 0.8, non-IRA lesion will be revascularized. |
| Immediate CR (complete revascularization) | Experimental | Procedure: Immediate complete revascularizationNon-infarct related artery (IRA) will be revascularized immediately after percutaneous coronary intervention (PCI) for IRA (during index PCI). Non-IRA lesion which have equal or more than 70% diameter stenosis by visual estimation will be revascularized without fractional flow reserve (FFR) evaluation. Non-IRA lesion with diameter stenosis 50-69% by visual estimation will be evaluated using FFR device. In case of FFR value more than 0.8, non-IRA lesion wll be deferred without PCI. If FFR value was equal or less than 0.8, non-IRA lesion will be revascularized. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age ≥ 19 years old
- Non-ST-segment elevation myocardial infarction
- PCI within 72 hours after symptom development
- Multivessel disease: Non-IRA with at least 2.5 mm diameter and 50% diameter stenosis by visual estimation
- Patient's or protector's agreement about study design and the risk of PCI
Key exclusion criteria (11 listed)
- Cardiogenic shock at initial presentation or after treatment of IRA
- TIMI flow at non-IRA ≤ 2
- Severe procedural complications (e.g. persistent no-reflow phenomenon, coronary artery perforation) which restricts study enrollment by operators' decision
- Non-IRA lesion not suitable for PCI treatment by operators' decision
- Chronic total occlusion at non-IRA
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 |
|---|---|---|
| Staged in-hospital complete revascularizationPatients with non-ST-segment elevation myocardial infarction and multivessel disease will be randomized after percutaneous coronary intervention (PCI) for infarct-related artery (IRA). All patients will be randomized to immediate complete revascularization group or staged revascularization group by 1:1 fashion. Staged in-hospital complete revascularization group will receive staged PCI for non-IRA in other day (during hospitalization) after PCI for IRA. Non-IRA lesion which have equal or more than 70% diameter stenosis by visual estimation will be revascularized without fractional flow reserve (FFR) evaluation. Non-IRA lesion with diameter stenosis 50-69% by visual estimation will be evaluated using FFR device. In case of FFR value more than 0.8, non-IRA lesion wll be deferred without PCI. If FFR value was equal or less than 0.8, non-IRA lesion will be revascularized. | Procedure or surgery | Staged in-hospital CR (complete revascularization) |
| Immediate complete revascularizationPatients with non-ST-segment elevation myocardial infarction and multivessel disease will be randomized after percutaneous coronary intervention (PCI) for infarct-related artery (IRA). All patients will be randomized to immediate complete revascularization group or staged revascularization group by 1:1 fashion. Immediate complete revascularization group will receive simultaneous PCI for both IRA and non-IRA during index PCI. Non-IRA lesion which have equal or more than 70% diameter stenosis by visual estimation will be revascularized without fractional flow reserve (FFR) evaluation. Non-IRA lesion with diameter stenosis 50-69% by visual estimation will be evaluated using FFR device. In case of FFR value more than 0.8, non-IRA lesion wll be deferred without PCI. If FFR value was equal or less than 0.8, non-IRA lesion will be revascularized. | Procedure or surgery | Immediate CR (complete revascularization) |
Primary outcome
Cumulative incidence rate of all-cause death, non-fatal myocardial infarction, or all unplanned revascularization
Time frame: Up to 12 months
Composite endpoint of all-cause death, non-fatal myocardial infarction, or all unplanned revascularization at 1 year from baseline
15 secondary outcomes
Rate of contrast-induced nephropathy
Time frame: Up to 12 months
Cumulative incidence rate of all unplanned revascularization
Time frame: Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Cumulative incidence rate of target-lesion revascularization
Time frame: Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Cumulative incidence rate of target-vessel revascularization
Time frame: Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Cumulative incidence rate of non-target vessel revascularization
Time frame: Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Cumulative incidence rate of all-cause death
Time frame: Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Cumulative incidence rate of cardiac death
Time frame: Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Cumulative incidence rate of non-cardiac death
Time frame: Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Cumulative incidence rate of non-fatal myocardial infarction
Time frame: Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Cumulative incidence rate of hospitalization for unstable angina
Time frame: Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Cumulative incidence rate of hospitalization for heart failure
Time frame: Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Cumulative incidence rate of definite or probable stent thrombosis
Time frame: Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Cumulative incidence rate of ischemic and hemorrhagic stroke
Time frame: Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Cumulative incidence rate of major bleeding (BARC [Bleeding Academic Research Consortium] definitions type 3 or 5)
Time frame: Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Cumulative incidence rate of all-cause death, non-fatal myocardial infarction, or all unplanned revascularization
Time frame: Index admission, 1 month, 6 months, 24 months, 36 months, 48 months, 60 months
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 28 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Min Chul Kim, MD principal investigator
Chonnam National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Staged in-hospital complete revascularization and Immediate complete revascularization in people with Myocardial Infarction, Acute and Multi-Vessel Coronary Artery Stenosis, run by Chonnam 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 12 inclusion and 11 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 28 Jul 2026. 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 Min Chul Kim, MD (82-62-220-6578, kmc3242@hanmail.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative incidence rate of all-cause death, non-fatal myocardial infarction, or all unplanned revascularization (time frame: Up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jul 2026.