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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00376571
First Posted: September 15, 2006
Last Update Posted: September 26, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Johnson & Johnson
Information provided by (Responsible Party):
Niels Ramsing Holm, Aarhus University Hospital Skejby
  Purpose
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.

Condition Intervention Phase
Coronary Artery Disease Procedure: Percutaneous coronary intervention Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Nordic Bifurcation Study. How to Use Drug Eluting Stents (DES) in Bifurcation Lesions? A Strategy of Routine Stenting Both Main Vessel and Side Branch Versus a Strategy of Routine Main Vessel Stenting and Optional Treatment of Side Branch

Further study details as provided by Niels Ramsing Holm, Aarhus University Hospital Skejby:

Primary Outcome Measures:
  • Combined end-point of cardiac death, MI, stent thrombosis or TVR. [ Time Frame: After 6 months ]

Secondary Outcome Measures:
  • Clinical: MACE (cardiac death, MI, stent thrombosis or TVR) during hospital period, after 1 and 8 months. Cardiac death, myocardial infarction, stent thrombosis, TVR, total death, TLR during hospital period, after 1, 6 and 8 months. Myocardial infarction [ Time Frame: During hospital period, after 1, 6 and months. ]
  • Angiographic: Restenosis of the main vessel and/or occlusion of the side branch. Late loss of main vessel and side branch after 8 months. Angiographic restenosis (>50% diameter stenosis) rate of main vessel and side branch after 8 months. [ Time Frame: After 8 months ]

Enrollment: 413
Study Start Date: October 2004
Study Completion Date: March 2011
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stenting of main vessel and side branch
Percutaneous coronary intervention
Procedure: Percutaneous coronary intervention
Comparing treatment of either "no side branch treatment" versus "stenting of main vessel and side branch treatment"
Other Names:
  • PCI
  • PTCA
Experimental: No side branch treatment
Percutaneous coronary intervention
Procedure: Percutaneous coronary intervention
Comparing treatment of either "no side branch treatment" versus "stenting of main vessel and side branch treatment"
Other Names:
  • PCI
  • PTCA

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Stable or unstable AP.
  • Bifurcation lesion of "LAD/diagonal", "Cx/obtuse marginal", "RCA-PDA/posterolateral branch or LM/Cx/LAD in a right dominant system.
  • Diameter of main vessel by visual estimate > 2.5 mm.
  • Diameter of side branch by visual estimate > 2.0 mm.
  • Signed informed consent.

Exclusion Criteria:

  • ST-elevation AMI within 24 hours.
  • Expected survival < 1 year.
  • S-creatinine > 200 Umol/l.
  • Allergy to Aspirin, Clopidogrel or Ticlopidine.
  • Allergy to sirolimus/paclitaxel.
  • Left main bifurcation in a non-right dominant system.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00376571


Locations
Denmark
Skejby Hospital, University of Aarhus
Aarhus, Denmark, 8200
Sponsors and Collaborators
Aarhus University Hospital Skejby
Johnson & Johnson
Investigators
Study Director: Leif Thuesen, MD Director, Cardiac Cath. Lab., Skejby Hospital, University of Aarhus
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Niels Ramsing Holm, MD, Aarhus University Hospital Skejby
ClinicalTrials.gov Identifier: NCT00376571     History of Changes
Other Study ID Numbers: 20040136
First Submitted: September 14, 2006
First Posted: September 15, 2006
Last Update Posted: September 26, 2016
Last Verified: September 2016

Keywords provided by Niels Ramsing Holm, Aarhus University Hospital Skejby:
PCI
Bifurcation lesion

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Glucuronyl glucosamine glycan sulfate
Anticoagulants
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Hypoglycemic Agents
Physiological Effects of Drugs