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Nordic Bifurcation Stent Technique Study (BIF II)

This study has been completed.
Sponsor:
Collaborator:
Cordis Corporation
Information provided by (Responsible Party):
Leif Thuesen, MD, Head of the cath. lab., Skejby Hospital
ClinicalTrials.gov Identifier:
NCT00292305
First received: February 13, 2006
Last updated: January 13, 2013
Last verified: January 2013
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Skejby Hospital:

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

Secondary Outcome Measures:
  • Clinical MACE [ Time Frame: December 2008 ] [ Designated as safety issue: Yes ]
  • MACE (cardiac death, myocardial infarction, stent thrombosis or TVR) [ Time Frame: during hospital period; after 1 and 8 months ] [ Designated as safety issue: Yes ]
  • Cardiac death [ Time Frame: during hospital period; after 1, 6 and 8 months ] [ Designated as safety issue: Yes ]
  • Myocardial infarction [ Time Frame: during hospital period; after 1, 6 and 8 months ] [ Designated as safety issue: Yes ]
  • Stent thrombosis [ Time Frame: during hospital period; after 1, 6 and 8 months ] [ Designated as safety issue: Yes ]
  • TVR [ Time Frame: during hospital period; after 1, 6 and 8 months ] [ Designated as safety issue: No ]
  • Total death [ Time Frame: during hospital period; after 1, 6 and 8 months ] [ Designated as safety issue: Yes ]
  • TLR [ Time Frame: during hospital period; after 1, 6 and 8 months ] [ Designated as safety issue: No ]
  • CCS-angina score [ Time Frame: after 6 and 8 months ] [ Designated as safety issue: No ]
  • Late loss of main vessel and side branch [ Time Frame: after 8 months ] [ Designated as safety issue: No ]
  • Percentual diameter stenosis of main vessel and side branch [ Time Frame: after 8 months ] [ Designated as safety issue: No ]
  • Angiographic restenosis (> 50% diameter stenosis) rate of main vessel and side branch [ Time Frame: after 8 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
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

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00292305

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

No publications provided

Responsible Party: Leif Thuesen, MD, Head of the cath. lab., MD, DMSc, Skejby Hospital
ClinicalTrials.gov Identifier: NCT00292305     History of Changes
Other Study ID Numbers: 20050116
Study First Received: February 13, 2006
Last Updated: January 13, 2013
Health Authority: Denmark: National Board of Health

Keywords provided by Skejby Hospital:
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 May 22, 2013