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Nordic Bifurcation Study. How to Use Drug Eluting Stents (DES) in Bifurcation Lesions?

Study acronym: BIFI
StatusCompleted
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Amendment history

  1. Minor

    Study Status, Sponsor/Collaborators

    Re-verified, no change to tracked fields

    v5

  2. Notable

    Lead sponsor: Jens Flensted Lassen to Aarhus University Hospital Skejby

    Secondary endpoints: details revised at 1 of 2 entries

    Study Status, Sponsor/Collaborators, Outcome Measuresv4

  3. Notable

    Lead sponsor: Leif Thuesen to Jens Flensted Lassen

    Study Status, Sponsor/Collaboratorsv3

  4. Notable

    Lead sponsor: Aarhus University Hospital Skejby to Leif Thuesen

    Primary endpoint revised; Enrollment target: 400 to 413; Primary completion date: Jun 2005; and 4 more

    Show all 8 changes in this update
    • Notable Lead sponsor: Aarhus University Hospital Skejby to Leif Thuesen
    • Notable Primary endpoint revised
      Show what changed
      Combined end-point of cardiac death, MI, stent thrombosis or TVR after 6 months.
    • Minor Enrollment target: 400 to 413
    • Minor Primary completion date: Jun 2005
    • Minor Completion date: Aug 2006 to Mar 2011
    • Minor Secondary endpoints: details revised at 2 of 2 entries
    • Minor Collaborator revised
      Show what changed
      Cordis,Johnson Blokken& 39, DK-3460 Birkerød, DenmarkJohnson
    • Minor Study arms: 0 to 2

    Study Identification, Study Status, Sponsor/Collaborators, Oversight, Study Design, Arms and Interventions, Outcome Measures, Eligibilityv2

  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
How to use drug eluting stents (DES) in bifurcation lesions. A strategy of routine stenting of both main vessel and side branch versus a strategy of routine main vessel stenting and optional treatment of side branch. A randomized Nordic multicenter study including 400 patients with angina pectoris with clinical angiographic follow-up.
Trial Details
NCT Number NCT00376571
Lead Sponsor Aarhus University Hospital Skejby
Collaborators: Johnson & Johnson
Conditions Coronary Artery Disease
Enrollment 413 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov