Timing of FFR-guided PCI for Non-IRA in NSTEMI and MVD (OPTION-NSTEMI)

Recruiting now · Not applicable

Conditions studied: Myocardial Infarction, Acute, Multi-Vessel Coronary Artery Stenosis, Multi Vessel Coronary Artery Disease

In brief

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.

Key facts

Study ID

NCT04968808

Run by

Chonnam National University Hospital

People needed

1014

Starts

2021-09-06

Expected to finish

2032-08-31

Last updated by the study team

2026-07-28

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• Pregnancy and lactation
• Life expectancy < 1-year
• Severe valvular disease
• History of CABG, or planned CABG
• Fibrinolysis before admission

Where it is running

• Chonnam National University Hospital — Gwangju, South Korea (enrolling)

Full record on ClinicalTrials.gov

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