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IRIS-Onyx Cohort in the IRIS-DES Registry

Study acronym: IRIS-Onyx
StatusActive, Not Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Dec 31, 2026 to Dec 31, 2027
    • Study completion pushed from Dec 31, 2030 to Dec 31, 2031
    v15
  2. Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 33 to 31
    v14
  3. Primary completion date: Dec 31, 2025 to Dec 31, 2026
    • Study completion date: Dec 31, 2029 to Dec 31, 2030
    v13
  4. Re-verified, no change to tracked fieldsv12
  5. Primary completion date: Sep 30, 2023 to Dec 31, 2025
    • Enrollment target: 4000 to 4500
    • Study completion date: Sep 30, 2027 to Dec 31, 2029
    • Site details revised at 5 of 33 sites
    v11
Show 9 earlier versionsHide 9 earlier versions
  1. Primary completion date: Sep 30, 2022 to Sep 30, 2023
    • Study completion date: Sep 30, 2026 to Sep 30, 2027
    • Site details revised at 29 of 33 sites
    v10
  2. Secondary endpoints: 10 to 11v9
  3. Primary completion date: Sep 30, 2021 to Sep 30, 2022
    • Study sites: 31 to 33
    • Study completion date: Sep 30, 2025 to Sep 30, 2026
    v8
  4. Primary completion date: Oct 31, 2018 to Sep 30, 2021
    • Study completion date: Oct 31, 2022 to Sep 30, 2025
    • Site details revised at 1 of 31 sites
    v7
  5. Primary endpoint revised
    • Secondary endpoints: 9 to 10
    v6
  6. Enrollment target: 1000 to 4000
    • Primary completion date: Oct 2018 to Oct 31, 2018
    • Study completion date: Oct 2022 to Oct 31, 2022
    v5
  7. Site details revised at 30 of 31 sitesv4
  8. Collaborators: 1 to 2v3
  9. Eligibility criteria revisedv2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 evaluate the relative effectiveness and safety of Onyx stent compared to other (drug eluting stents) DES.
Trial Details
NCT Number NCT02593994
Lead Sponsor Seung-Jung Park
Collaborators: CardioVascular Research Foundation, Korea, Medtronic Korea Co., Ltd.
Conditions
(from sponsor)		 Coronary Artery Disease, Arterial Occlusive Diseases, Cardiovascular Diseases, Percutaneous Transluminal Angioplasty
Related terms Arterial Occlusive Diseases, Cardiovascular Diseases, Coronary Artery Disease
Enrollment 4,500 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov