Nordic Bifurcation Study. How to Use Drug Eluting Stents (DES) in Bifurcation Lesions? (BIFI)

This study has been completed.
Sponsor:
Collaborator:
Johnson & Johnson
Information provided by (Responsible Party):
Jens Flensted Lassen, Aarhus University Hospital Skejby
ClinicalTrials.gov Identifier:
NCT00376571
First received: September 14, 2006
Last updated: July 24, 2013
Last verified: July 2013
  Purpose

How to use drug eluting stents (DES) in bifurcation lesions. A strategy of routine stenting of both main vessel and side branch versus a strategy of routine main vessel stenting and optional treatment of side branch. 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: Nordic Bifurcation Study. How to Use Drug Eluting Stents (DES) in Bifurcation Lesions? A Strategy of Routine Stenting Both Main Vessel and Side Branch Versus a Strategy of Routine Main Vessel Stenting and Optional Treatment of Side Branch

Further study details as provided by Aarhus University Hospital Skejby:

Primary Outcome Measures:
  • Combined end-point of cardiac death, MI, stent thrombosis or TVR. [ Time Frame: After 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical: MACE (cardiac death, MI, stent thrombosis or TVR) during hospital period, after 1 and 8 months. Cardiac death, myocardial infarction, stent thrombosis, TVR, total death, TLR during hospital period, after 1, 6 and 8 months. Myocardial infarction [ Time Frame: During hospital periode, after 1, 6 and months. ] [ Designated as safety issue: No ]
  • Angiographic: Restenosis of the main vessel and/or occlusion of the side branch. Late loss of main vessel and side branch after 8 months. Angiographic restenosis (>50% diameter stenosis) rate of main vessel and side branch after 8 months. [ Time Frame: After 8 months ] [ Designated as safety issue: No ]

Enrollment: 413
Study Start Date: October 2004
Study Completion Date: March 2011
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stenting of main vessel and side branch
Percutaneous coronary intervention
Procedure: Percutaneous coronary intervention
Comparing treatment of either "no side branch treatment" versus "stenting of main vessel and side branch treatment"
Other Names:
  • PCI
  • PTCA
Experimental: No side branch treatment
Percutaneous coronary intervention
Procedure: Percutaneous coronary intervention
Comparing treatment of either "no side branch treatment" versus "stenting of main vessel and side branch treatment"
Other Names:
  • PCI
  • PTCA

  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 in a right dominant system.
  • Diameter of main vessel by visual estimate > 2.5 mm.
  • Diameter of side branch by visual estimate > 2.0 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/paclitaxel.
  • 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: NCT00376571

Locations
Denmark
Skejby Hospital, University of Aarhus
Aarhus, Denmark, 8200
Sponsors and Collaborators
Jens Flensted Lassen
Johnson & Johnson
Investigators
Study Director: Leif Thuesen, MD Director, Cardiac Cath. Lab., Skejby Hospital, University of Aarhus
  More 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: NCT00376571     History of Changes
Other Study ID Numbers: 20040136
Study First Received: September 14, 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
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on September 16, 2014