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Observational Study for Left Main Disease Treatment

Study acronym: IRIS-MAIN
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint reworded 1 of 1 changed
See other at-risk trials from Seung-Jung Park

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary endpoint(s) modified Show 5 more changesShow less
    • Eligibility criteria expanded, about 6 words
    • Secondary endpoints revised (9)
    • Study description revised
    • Site details revised at 10 of 42 sites
    • Publications: details revised at 5 of 5 entries
  2. 2 versions Re-verified since Jun 24, 2024, no change to tracked fieldsv14-v15
  3. Site contacts updated at 1 of 42 sitesv13
  4. Primary completion date: Dec 2022 to Dec 2032
    • Site details revised at 3 of 42 sites
    v12
  5. Study Status, Outcome Measuresv11
Show 9 earlier versionsHide 9 earlier versions
  1. Primary completion date: Jul 2020 to Dec 2022v10
  2. Study sites: 41 to 42
    • Study completion date: Jul 2030 to Dec 2033
    v9
  3. Study sites: 21 to 41v8
  4. Enrollment target: 5000 to 10000
    • Primary completion date: Jul 2017 to Jul 2020
    • Study completion date: Jul 2019 to Jul 2030
    v7
  5. Re-verified, no change to tracked fieldsv6
  6. Collaborators: 5 to 1v5
  7. Collaborators: 1 to 5v4
  8. Lead sponsor: CardioVascular Research Foundation, Korea to Seung-Jung Parkv3 Show 5 more changesShow less
    • Enrollment target: 3000 to 5000
    • Interventions: CABG (Procedure), Medication (Procedure), PCI (Procedure) to not stated
    • Study description expanded, about 71 words
    • Collaborators expanded, about 4 words
    • Study title shortened, about 2 words
  9. Re-verified, no change to tracked fieldsv2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The purpose of this study is to observe clinical courses for long-term in patients with unprotected LMCA disease and to evaluate comparative results of medical treatment, coronary stenting with drug-eluting stents, and CABG for the treatment of an unprotected LMCA stenosis in the "real world" daily practice.
Trial Details
NCT Number NCT01341327
Lead Sponsor Seung-Jung Park
Collaborators: CardioVascular Research Foundation, Korea
Conditions
(from sponsor)		 Coronary Artery Disease
Related terms Coronary Artery Disease
Enrollment 10,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov