NCT04626882Active, not recruiting
Timing of FFR-guided PCI for Non-IRA in STEMI and MVD (OPTION-STEMI)
OPtimal TIming of Fractional Flow Reserve-Guided Complete RevascularizatiON for Non-Infarct Related Artery in ST-Segment Elevation Myocardial Infarction With Multivessel Disease (OPTION-STEMI)
Source: ClinicalTrials.gov · Last updated 7 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 994 (actual)
- First submitted
- 2 Nov 2020
- Start date
- 30 Dec 2019
- Primary completion date
- 15 Jan 2025
- Lead sponsor
- Chonnam National University Hospital
- Diseases
- Coronary artery disease
- NCT number
- NCT04626882
What you commit to
- Study type: Interventional
- Participants enrolled: 994
- From 30 Dec 2019 to the primary completion date, 15 Jan 2025
- 14 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
- History of anaphylaxis to contrast agent
- Severe valvular disease
- History of CABG (coronary artery bypass graft), or planned CABG
Other
- Cardiogenic shock at initial presentation or after treatment of IRA
- Non-IRA lesion not suitable for PCI treatment by operators' decision
- Chronic total occlusion at non-IRA
- Pregnancy and lactation
- Life expectancy \< 1-year
- Fibrinolysis before admission
- Severe asthma
- Patient's refusal to participate in study
Who the study is looking for
- 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
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (14)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Catholic University of Korea, Bucheon St. Mary's Hospital Coordinator of this site? Confirm its status | Bucheon-si | South Korea | Unknown status |
| Gyeongsang National University Changwon hospital Coordinator of this site? Confirm its status | Changwon | South Korea | Unknown status |
| Yeongnam University Medical Center Coordinator of this site? Confirm its status | Daegu | South Korea | Unknown status |
| Gangneung Asan Hospital Coordinator of this site? Confirm its status | Gangneung | South Korea | Unknown status |
| Chonnam National University Hospital Coordinator of this site? Confirm its status | Gwangju | South Korea | Unknown status |
| Chonbuk National University Hospital Coordinator of this site? Confirm its status | Jeonju | South Korea | Unknown status |
| Presbyterian Medical Center Coordinator of this site? Confirm its status | Jeonju | South Korea | Unknown status |
| Gyeongsang National University Hospital Coordinator of this site? Confirm its status | Jinju | South Korea | Unknown status |
| Kyung Hee University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Koera University Guro Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| The Catholic University of Korea, Seoul ST. Mary's Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| St. Carollo General Hospital Coordinator of this site? Confirm its status | Suncheon | South Korea | Unknown status |
| The Catholic University of Korea Uijeongbu St. Mary's Hospital Coordinator of this site? Confirm its status | Uijeongbu-si | South Korea | Unknown status |
| Yonsei University Wonju Severance Christian Hospital Coordinator of this site? Confirm its status | Wŏnju | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.