NCT04968808Recruiting
Timing of FFR-guided PCI for Non-IRA in NSTEMI and MVD (OPTION-NSTEMI)
OPtimal TIming of Fractional Flow Reserve-Guided Complete RevascularizatiON in Non-ST-Segment Elevation Myocardial Infarction (OPTION-NSTEMI)
Source: ClinicalTrials.gov · Last updated 28 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 1014 (estimated)
- First submitted
- 9 Jul 2021
- Start date
- 6 Sept 2021
- Primary completion date
- 31 Aug 2028
- Lead sponsor
- Chonnam National University Hospital
- Diseases
- Coronary artery disease
- NCT number
- NCT04968808
What you commit to
- Study type: Interventional
- Planned participants: 1014
- From 6 Sept 2021 to the primary completion date, 31 Aug 2028
- 1 site 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
- 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, or planned CABG
Other
- Cardiogenic shock at initial presentation or after treatment of IRA
- TIMI flow at non-IRA ≤ 2
- 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
Who the study is looking for
- 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
- 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
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chonnam National University Hospital Coordinator of this site? Confirm its status | Gwangju | South Korea | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.