Timing of FFR-guided PCI for Non-IRA in STEMI and MVD (OPTION-STEMI) (NCT04626882) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Timing of FFR-guided PCI for Non-IRA in STEMI and MVD (OPTION-STEMI)
South Korea994 participantsStarted 2019-12-30
Plain-language summary
Patients with STEMI (ST-segment elevation myocardial infarction) with multivessel disease which have PCI (percutaneous coronary intervention)-suitable non-IRA (infarct related artery) will be randomized to immediate complete revascularization group or staged revascularization group by 1:1 fashion. Non-IRA lesion which have equal or more than 70% diameter stenosis by visual estimation will be revascularized without FFR (fractional flow reserve) evaluation. Non-IRA lesion with diameter stenosis 50-70% 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 can participate
Age range
19 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥ 19 years old
* ST-segment elevation myocardial infarction
* ST-segment elevation in at least 2 contiguous leads or,
* New onset left bundle branch block
* Primary PCI within 12 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
Exclusion Criteria:
* Cardiogenic shock at initial presentation or after treatment of IRA
* Unprotected left main coronary artery disease with at least 50% diameter stenosis by visual estimation
* TIMI (Thrombolysis in Myocardial Infarction) 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
* Pregnancy and lactation
* Life expectancy \< 1-year
* Severe valvular disease
* History of CABG (coronary artery bypass graft), or planned CABG
* Fibrinolysis before admission
* Severe asthma
* Patient's refusal to participate in study
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Cumulative incidence rate of all-cause death, non-fatal myocardial infarction, or all unplanned revascularization at 1 year from baseline