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Fractional Flow Reserve Versus Angiography for Treatment-Decision and Evaluation of Significant Left MAIN Coronary Artery Disease

Study acronym: FATE-MAIN
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Minor Study sites: 48 to 49v11
  2. Minor Study sites: 2 to 48v10
  3. Minor Enrollment target: 934 to 960v9
  4. Notable Phase: Phase 4 to Not applicable
    • Eligibility criteria expanded, about 99 words
    v8
  5. Minor Study sites: 1 to 2v7
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  1. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date: Jan 15, 2024 to Apr 25, 2024
    • Site details revised
    v6
  2. Notable Start date: Oct 15, 2023 to Jan 15, 2024v5
  3. Notable Start date: Jun 15, 2023 to Oct 15, 2023v4 Show 4 more changesShow less
    • Enrollment target: 930 to 934
    • Secondary endpoints: 17 to 16
    • Study description expanded, about 64 words
    • Eligibility criteria expanded, about 3 words
  4. Minor Secondary endpoints: 18 to 17v3
  5. Minor Secondary endpoints: details revised at 2 of 18 entriesv2
  1. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The primary purpose of the study was to determine whether the 2-year probability of major adverse cardiac events (primary composite outcome) differed significantly between patients who underwent angiography-guided Percutaneous Coronary Intervention(PCI) and those who underwent Fractional Flow Reserve(FFR)-guided PCI in patients with Left Main Coronary Artery disease(LMCA).
Trial Details
NCT Number NCT05829889
Lead Sponsor Seung-Jung Park
Collaborators: CardioVascular Research Foundation, Korea
Conditions
(from sponsor)
Coronary Artery Disease Left Main, Coronary Artery Disease
Related terms Coronary Artery Disease
Enrollment 960 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov