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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):
Jens Flensted Lassen, Aarhus University Hospital Skejby
ClinicalTrials.gov Identifier:
NCT00292305
First received: February 13, 2006
Last updated: July 24, 2013
Last verified: July 2013
  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:


Further study details as provided by Aarhus University Hospital Skejby:

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
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: 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

No publications provided

Responsible Party: Jens Flensted Lassen, MD, DMSc, Aarhus University Hospital Skejby
ClinicalTrials.gov Identifier: NCT00292305     History of Changes
Other Study ID Numbers: 20050116
Study First Received: February 13, 2006
Last Updated: July 24, 2013
Health Authority: Denmark: National Board of Health

Keywords provided by Aarhus University Hospital Skejby:
PCI
Bifurcation lesion

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 24, 2014