The Nordic Bifurcation Study III (BIF III)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Johnson & Johnson
Information provided by (Responsible Party):
Jens Flensted Lassen, Aarhus University Hospital Skejby
ClinicalTrials.gov Identifier:
NCT00914199
First received: June 3, 2009
Last updated: September 4, 2014
Last verified: September 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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?

Resource links provided by NLM:


Further study details as provided by 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 ] [ Designated as safety issue: Yes ]

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

Enrollment: 477
Study Start Date: April 2007
Estimated Study Completion Date: December 2016
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

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00914199

Locations
Denmark
Aarhus University Hospital Skejby
Aarhus, Denmark, 8200
Sponsors and Collaborators
Jens Flensted Lassen
Johnson & Johnson
Investigators
Principal Investigator: Jens F Lassen, MD Director Cardiac Lab, Aarhus University Hospital Skejby
  More Information

Additional Information:
No publications provided by Aarhus University Hospital Skejby

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jens Flensted Lassen, M.D., D.M.Sc., Aarhus University Hospital Skejby
ClinicalTrials.gov Identifier: NCT00914199     History of Changes
Other Study ID Numbers: 20070005
Study First Received: June 3, 2009
Last Updated: September 4, 2014
Health Authority: Denmark: National Board of Health

Keywords provided by 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

ClinicalTrials.gov processed this record on September 30, 2014