Timing of FFR-guided PCI for Non-IRA in NSTEMI and MVD (OPTION-NSTEMI) (NCT04968808) | Clinical Trial Compass
RecruitingNot Applicable
Timing of FFR-guided PCI for Non-IRA in NSTEMI and MVD (OPTION-NSTEMI)
South Korea1,014 participantsStarted 2021-09-01
Plain-language summary
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.
Who can participate
Age range19 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
✓. 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
Exclusion criteria
✕. 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
What they're measuring
1
Cumulative incidence rate of all-cause death, non-fatal myocardial infarction, or all unplanned revascularization