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Drug-Eluting Balloon Registry in Routine Clinical Practice

Study acronym: IRIS DEB
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Notable Primary completion date: Dec 31, 2024 to Dec 31, 2026
    • Study sites: 8 to 9
    • Study completion date: Jun 2028 to Jun 2027
    v15
  2. Minor Re-verified, no change to tracked fieldsv14
  3. Notable Primary completion date: Dec 31, 2022 to Dec 31, 2024
    • Study completion date: Jun 2026 to Jun 2028
    • Site details revised at 6 of 8 sites
    v13
  4. Notable Enrollment target: 1000 to 1500
    • Site contacts updated at 1 of 8 sites
    v12
  5. Minor Secondary endpoints: 9 to 10v11
Show 9 earlier versionsHide 9 earlier versions
  1. Notable Primary completion date: Dec 2020 to Dec 31, 2022
    • Site details revised at 2 of 8 sites
    v10
  2. Notable Primary completion date: Dec 2019 to Dec 2020
    • Study sites: 7 to 8
    v9
  3. Notable Enrollment target: 300 to 1000
    • Study completion date: Jun 2023 to Jun 2026
    v8
  4. Minor Re-verified, no change to tracked fieldsv7
  5. Minor Study completion date: Dec 2020 to Jun 2023
    • Site details revised at 6 of 7 sites
    v6
  6. Minor Collaborators expanded, about 9 wordsv5
  7. Minor Eligibility criteria revisedv4
  8. Minor Interventions: BALLOON ANGIOPLASTY (Device) to Balloon angioplasty (Device)
    • Secondary endpoints revised (9)
    • Primary endpoint revised
    v3
  9. Minor Re-verified, no change to tracked fieldsv2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 purpose of this study is to evaluate long-term effectiveness and safety of patients with coronary disease treated with drug eluting balloon in real world practice.
Trial Details
NCT Number NCT02038660
Lead Sponsor Seung-Jung Park
Collaborators: CardioVascular Research Foundation, Korea, B. Braun Korea Co., Ltd.
Conditions
(from sponsor)
Coronary Artery Disease, Angioplasty, Balloon
Related terms Coronary Artery Disease
Enrollment 1,500 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov