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BIOFLOW-VIII All-comers Orsiro Mission Safety and Performance Registry

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

Record History

  1. Minor Re-verified, no change to tracked fieldsv7
  2. Notable Primary completion date: Jan 21, 2022 to Jan 18, 2023 Trial status: Completed to Active, Not Recruiting · Study sites: 40 to 41 · Completion date: Jan 21, 2022 to Feb 19, 2027v6 Show 3 more changesShow less
    • Trial status: Completed to Active, Not Recruiting
    • Study sites: 40 to 41
    • Completion date: Jan 21, 2022 to Feb 19, 2027
  3. Minor Trial status: Recruiting to Completed Enrollment target: estimated 868 to confirmed 872 · Study sites: 44 to 40 · Primary completion date changed from estimate of Mar 2023 to Jan 21, 2022 · 1 morev5 Show 4 more changesShow less
    • Enrollment target: estimated 868 to confirmed 872
    • Study sites: 44 to 40
    • Primary completion date changed from estimate of Mar 2023 to Jan 21, 2022
    • Study completion date changed from estimate of Mar 2027 to Jan 21, 2022
  4. Minor Study sites: 31 to 44v4
  5. Minor Study sites: 34 to 31 Eligibility criteria expanded, about 36 wordsv3 Show 1 more changeShow less
    • Eligibility criteria expanded, about 36 words

    See this version in full on ClinicalTrials.gov ↗

  6. Notable Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Sep 2020 to Sep 25, 2020 · Site details revised at 34 of 34 sitesv2 Show 2 more changesShow less
    • Start date changed from estimate of Sep 2020 to Sep 25, 2020
    • Site details revised at 34 of 34 sites
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 BIOFLOW-VIII registry is a post-market clinical evaluation of the Orsiro Mission stent in subjects requiring coronary revascularization with Drug Eluting Stents (DES).
Trial Details
NCT Number NCT04555174
Lead Sponsor Biotronik AG
Collaborators: Biotronik France
Conditions Coronary Artery Disease, Myocardial Ischemia
Enrollment 872 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov