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Timing of FFR-guided PCI for Non-IRA in STEMI and MVD (OPTION-STEMI)
Sponsor: Chonnam National University Hospital
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.
Official title: 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)
Key Details
Gender
All
Age Range
19 Years - Any
Study Type
INTERVENTIONAL
Enrollment
994
Start Date
2019-12-30
Completion Date
2029-12-31
Last Updated
2025-05-30
Healthy Volunteers
No
Interventions
Staged in-hospital or Immediate complete revascularization
Patients with ST-segment elevation myocardial infarction and multivessel disease will be randomized after primary PCI for IRA. All patients 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 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.
Locations (14)
The Catholic University of Korea, Bucheon St. Mary's Hospital
Bucheon-si, South Korea
Gyeongsang National University Changwon Hospital
Changwon, South Korea
Yeongnam University Medical Center
Daegu, South Korea
GangNeung Asan Hospital
Gangneung, South Korea
Chonnam National University Hospital
Gwangju, South Korea
Chonbuk National University Hospital
Jeonju, South Korea
Presbyterian Medical Center
Jeonju, South Korea
Gyeongsang National University Hospital
Jinju, South Korea
Koera University Guro Hospital
Seoul, South Korea
Kyung Hee University Hospital
Seoul, South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, South Korea
St. Carollo General Hospital
Suncheon, South Korea
The Catholic University of Korea, Uijeongbu St. Mary's Hospital
Uijeongbu-si, South Korea
Yonsei University, Wonju Severance Christian Hospital
Wŏnju, South Korea