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

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Study completion pushed from Aug 31, 2028 to Aug 31, 2032v9
  2. Start date: Sep 1, 2021 to Sep 6, 2021
    • Secondary endpoints: 14 to 15
    v8
  3. Re-verified, no change to tracked fieldsv7
  4. Enrollment target: 676 to 1014v6
  5. Primary completion date: Aug 31, 2024 to Aug 31, 2028
    • Study completion date: Aug 31, 2025 to Aug 31, 2028
    v5
Show 3 earlier versionsHide 3 earlier versions
  1. Primary endpoint revised
    • Secondary endpoints revised (14)
    v4
  2. Re-verified, no change to tracked fieldsv3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Aug 1, 2021 to Sep 1, 2021
    • Site details revised
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
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.
Trial Details
NCT Number NCT04968808
Lead Sponsor Chonnam National University Hospital
Conditions
(from sponsor)		 Myocardial Infarction, Acute, Multi-Vessel Coronary Artery Stenosis, Multi Vessel Coronary Artery Disease
Related terms Myocardial Infarction
Enrollment 1,014 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov