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Study of the Natural History of FFR Guided Percutaneous Coronary Intervention

Study acronym: IRIS FFR
StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Site contacts updated at 29 of 29 sitesv20
  2. Study description revisedv19
  3. Primary and study completion dates: Apr 2026 to Apr 2037
    • Enrollment target: 15000 to 20000
    • Site contacts updated at 29 of 29 sites
    v18
  4. Site contacts updated at 1 of 29 sitesv17
  5. Re-verified, no change to tracked fieldsv16
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  1. Site details revised at 28 of 29 sitesv15
  2. 2 versions Re-verified since Dec 16, 2019, no change to tracked fieldsv13-v14
  3. Enrollment target: 10000 to 15000
    • Primary and study completion dates: Apr 2022 to Apr 2026
    • Study description revised
    v12
  4. Primary and study completion dates: Dec 2020 to Apr 2022v11
  5. Primary and study completion dates: Jun 2017 to Dec 2020
    • Study sites: 30 to 29
    v10
  6. Study sites: 1 to 30v9
  7. Eligibility criteria shortened, about 18 words
    • Study description shortened, about 31 words
    • Study title expanded, about 1 word
    v8
  8. Collaborators: 1 to 2v7
  9. Study description revisedv6
  10. Enrollment target: 2000 to 10000
    • Primary and study completion dates: Jun 2015 to Jun 2017
    v5
  11. Lead sponsor: Duk-Woo Park to Seung-Jung Park
    • Secondary endpoints revised (18)
    • Study description expanded, about 50 words
    • Collaborators expanded, about 4 words
    v4
  12. Lead sponsor: CardioVascular Research Foundation, Korea to Duk-Woo Park
    • Trial status: Not Yet Recruiting to Recruiting
    • Eligibility criteria expanded, about 13 words
    • Site details revised
    v3
  13. Secondary endpoints: 2 to 18v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
About 20,000 patients with FFR (Fractional Flow Reserve) will be enrolled and evaluated for the natural history of coronary lesions at 2 years clinical and imaging follow-up.
Trial Details
NCT Number NCT01366404
Lead Sponsor Seung-Jung Park
Collaborators: CardioVascular Research Foundation, Korea, Abbott Medical Devices
Conditions
(from sponsor)		 Coronary Artery Disease
Related terms Coronary Artery Disease
Enrollment 20,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov