Nordic Bifurcation Stent Technique Study (BIF II)

Study acronym: BIF II
StatusCompleted
PhasePhase 4
Started

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Record History

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  1. Re-verified, no change to tracked fieldsv15
  2. Enrollment target: estimated 400 to confirmed 425
    • Study description revised
    v14
  3. Re-verified, no change to tracked fieldsv13
  4. Trial status: Active, Not Recruiting to Completedv12
  5. Primary completion date changed from estimate of Sep 2008 to Feb 2007v11 Show 4 more changesShow less
    • Study completion date: Jul 2010 to Dec 2012
    • Interventions: Percutaneous coronary intervention: (crush stenting) (Procedure), Percutaneous coronary intervention: (culotte stenting) (Procedure) to Percutaneous coronary intervention (Procedure)
    • Collaborator revised
    • Study title expanded, about 2 words
Show 9 earlier versionsHide 9 earlier versions
  1. Study description shortened, about 72 wordsv10
  2. Secondary endpoints revised (12)v9
  3. Primary endpoint revisedv8 Show 5 more changesShow less
    • Interventions: Percutaneous coronary intervention (Procedure) to Percutaneous coronary intervention: (crush stenting) (Procedure), Percutaneous coronary intervention: (culotte stenting) (Procedure)
    • Secondary endpoints revised (12)
    • Study description expanded, about 12 words
    • Study arms: 1 to 2
    • Eligibility criteria expanded, about 5 words
  4. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v7
  5. Primary completion date: Sep 2008
    • Study completion date: Sep 2007 to Jul 2010
    • Secondary endpoints: 14 to 12
    • Study arms: 0 to 1
    v6
  6. 3 versions Re-verified since Jul 3, 2006, no change to tracked fieldsv3-v5
  7. Eligibility criteria revised
    • Secondary endpoints revised (14)
    v2
  1. Study First Submitted
  • 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.
This is a study of crush- or culotte stenting of bifurcation lesions using drug eluting stents. This is a randomized Nordic multicenter study including 400 patients with angina pectoris with clinical angiographic follow-up.
Trial Details
NCT Number NCT00292305
Lead Sponsor Aarhus University Hospital Skejby
Collaborators: Cordis US Corp.
Conditions
(from sponsor)		 Coronary Artery Disease
Related terms Coronary Artery Disease
Enrollment 425 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov