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The Nordic Bifurcation Study III (BIF III)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00914199
First Posted: June 4, 2009
Last Update Posted: September 23, 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
Should we, or should we not, perform dilatation of the side branch through the main vessel stent, if there is acceptable blood flow in the side branch?

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Stenting of Coronary Artery Stenoses With Significant Side Branches. Should we, or Should we Not, Perform Dilatation of the Side Branch Through the Main Vessel Stent, if There is Acceptable Blood Flow in the Side Branch?

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

Primary Outcome Measures:
  • Combined end point of: cardiac death, index lesion myocardial infarction, stent thrombosis or target lesion revascularisation [ Time Frame: After 6 months ]

Secondary Outcome Measures:
  • MACE (cardiac death, myocardial infarction, stent thrombosis or target vessel revascularisation) [ Time Frame: during hospital period, after 1, 8, and 14 months, 2 and 3 years ]
  • Cardiac death [ Time Frame: during hospital period, after 1, 8 and 14 months, 2 and 3 years ]
  • Myocardial infarction [ Time Frame: during hospital period, after 1, 8 and 14 months, 2 and 3 years ]
  • Stent thrombosis [ Time Frame: during hospital period, after 1, 8 and 14 months, 2 and 3 years ]
  • Target vessel revascularisation [ Time Frame: during hospital period, after 1, 8 and 14 months, 2 and 3 years ]
  • Total mortality [ Time Frame: during hospital period, after 1, 6, 8 and 14 months, 2 and 3 years ]
  • Target lesion revascularisation [ Time Frame: during hospital period, after 1, 8 and 14 months, 2 and 3 years ]
  • Myocardial infarction [ Time Frame: related to the index procedure ]
  • CCS angina score [ Time Frame: after 1, 8 and 14 months, 2 and 3 years ]
  • Angiographic significant stenosis (>50%) of main vessel and/or occlusion of the side branch [ Time Frame: after 8 months ]
  • Late loss of main vessel and side branch [ Time Frame: after 8 months ]
  • Angiographic significant stenosis (>50%) of main vessel and/or side branch [ Time Frame: after 8 months ]
  • Angiographic significant stenosis (>50%) of main vessel [ Time Frame: after 8 months ]
  • Angiographic significant stenosis (>50%) of side branch [ Time Frame: after 8 months ]
  • Markers [ Time Frame: before and after the procedure ]

Enrollment: 477
Study Start Date: April 2007
Estimated Study Completion Date: October 2018
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Kissing balloon post-dilatation
Percutaneous coronary intervention with implantation of stent using kissing balloon dilatation
Procedure: Percutaneous coronary intervention (PCI)
Implantation of coronary stent in bifurcation lesion.
Other Names:
  • Percutaneous coronary intervention technique
  • PCI
  • PTCA
Experimental: No kissing balloon post-dilatation
Percutaneous coronary intervention with implantation of stent and not using kissing balloon postdilatation
Procedure: Percutaneous coronary intervention (PCI)
Implantation of coronary stent in bifurcation lesion.
Other Names:
  • Percutaneous coronary intervention technique
  • 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 angina pectoris. -Bifurcation lesion of "LAD/diagonal", "Cx/obtuse marginal", "RCA--
  • PDA/posterola¬te¬ral branch" or "LM/Cx/LAD".
  • Diameter of main vessel by visual estimate > 2.5 mm.
  • Diameter of side branch by visual estimate > 2.25 mm.
  • Signed informed consent

Exclusion Criteria:

  • Age < 18 years.
  • ST-elevation infarction within 24 hours.
  • Expected survival < 1 year.
  • S-creatinine > 200 µmol/l.
  • Allergy to Aspirin, Clopidogrel or Ticlopidine.
  • Allergy to Sirolimus.
  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): NCT00914199


Locations
Denmark
Aarhus University Hospital Skejby
Aarhus, Denmark, 8200
Sponsors and Collaborators
Niels Ramsing Holm
Johnson & Johnson
Investigators
Principal Investigator: Niels R Holm, MD MD
  More Information

Additional 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: NCT00914199     History of Changes
Other Study ID Numbers: 20070005
First Submitted: June 3, 2009
First Posted: June 4, 2009
Last Update Posted: September 23, 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