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Nordic Bifurcation Stent Technique Study (BIF II) (BIF II)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00292305
First Posted: February 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:
Cordis Corporation
Information provided by (Responsible Party):
Niels Ramsing Holm, Aarhus University Hospital Skejby
  Purpose
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.

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: Crush- or Culotte Stenting of Bifurcation Lesions Using Drug Eluting Stents? A Randomized Nordic Multicenter Study (BIF II)

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

Primary Outcome Measures:
  • Combined end point of: cardiac death, myocardial infarction, stent thrombosis or TVR [ Time Frame: after 6 months ]

Secondary Outcome Measures:
  • Clinical MACE [ Time Frame: December 2008 ]
  • MACE (cardiac death, myocardial infarction, stent thrombosis or TVR) [ Time Frame: during hospital period; after 1 and 8 months ]
  • Cardiac death [ Time Frame: during hospital period; after 1, 6 and 8 months ]
  • Myocardial infarction [ Time Frame: during hospital period; after 1, 6 and 8 months ]
  • Stent thrombosis [ Time Frame: during hospital period; after 1, 6 and 8 months ]
  • TVR [ Time Frame: during hospital period; after 1, 6 and 8 months ]
  • Total death [ Time Frame: during hospital period; after 1, 6 and 8 months ]
  • TLR [ Time Frame: during hospital period; after 1, 6 and 8 months ]
  • CCS-angina score [ Time Frame: after 6 and 8 months ]
  • Late loss of main vessel and side branch [ Time Frame: after 8 months ]
  • Percentual diameter stenosis of main vessel and side branch [ Time Frame: after 8 months ]
  • Angiographic restenosis (> 50% diameter stenosis) rate of main vessel and side branch [ Time Frame: after 8 months ]

Enrollment: 425
Study Start Date: September 2005
Study Completion Date: December 2012
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: T-crush stenting
Percutaneous coronary intervention with implantation of a stent
Procedure: Percutaneous coronary intervention
Implantation of coronary stent in bifurcation lesions
Other Names:
  • PCI
  • PTCA
  • Techniques
  • Crush
  • Culotte
Active Comparator: Culotte stenting
Percutaneous coronary intervention with stent
Procedure: Percutaneous coronary intervention
Implantation of coronary stent in bifurcation lesions
Other Names:
  • PCI
  • PTCA
  • Techniques
  • Crush
  • Culotte

  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".
  • Diameter of main vessel by visual estimate > 3.0 mm.
  • Diameter of side branch by visual estimate > 2.5 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.
  • 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): NCT00292305


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

Responsible Party: Niels Ramsing Holm, MD, Aarhus University Hospital Skejby
ClinicalTrials.gov Identifier: NCT00292305     History of Changes
Other Study ID Numbers: 20050116
First Submitted: February 13, 2006
First Posted: February 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


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