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

NARecruitingINTERVENTIONAL
Enrollment

1,014

Participants

Timeline

Start Date

September 1, 2021

Primary Completion Date

August 31, 2028

Study Completion Date

August 31, 2028

Conditions
Myocardial Infarction, AcuteMulti-Vessel Coronary Artery StenosisMulti Vessel Coronary Artery Disease
Interventions
PROCEDURE

Staged in-hospital complete revascularization

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.

PROCEDURE

Immediate complete revascularization

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.

Trial Locations (1)

Unknown

RECRUITING

Chonnam National University Hospital, Gwangju

All Listed Sponsors
lead

Chonnam National University Hospital

OTHER