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

StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv11
  2. Primary completion date changed from estimate of Feb 28, 2025 to Jan 15, 2025v10
  3. Re-verified, no change to tracked fieldsv9
  4. Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 22 to 14
    v8
  5. Study sites: 21 to 22v7
Show 5 earlier versionsHide 5 earlier versions
  1. Primary endpoint revised
    • Secondary endpoints revised (15)
    • Site contacts updated at 2 of 21 sites
    v6
  2. Site details revised at 5 of 21 sitesv5
  3. Enrollment target: 784 to 994v4 Show 6 more changesShow less
    • Primary completion date: Dec 31, 2024 to Feb 28, 2025
    • Study completion date: Dec 31, 2024 to Dec 31, 2029
    • Start date: Dec 31, 2019 to Dec 30, 2019
    • Eligibility criteria expanded, about 6 words
    • Secondary endpoints: 14 to 15
    • Site details revised at 2 of 21 sites
  4. Re-verified, no change to tracked fieldsv3
  5. Study title expanded, about 1 wordv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04626882
Lead Sponsor Chonnam National University Hospital
Conditions
(from sponsor)		 Myocardial Infarction, Acute, Multi-Vessel Coronary Artery Stenosis
Related terms Myocardial Infarction
Enrollment 994 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov