Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

The Nordic-Baltic Bifurcation Study IV (BIF IV)

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:
NCT01496638
First received: December 19, 2011
Last updated: September 4, 2014
Last verified: September 2014
  Purpose

How should coronary artery stenoses with significant side branch be stented?

A strategy of stenting both main vessel and side branch compared to a strategy of stenting the main vessel and only stenting the side branch if necessary.

The 2-stent strategy is superior to the 1-stent strategy regarding occurrence of cardiac death, non-procedure related myocardial infarction and re-revascularization with percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG).


Condition Intervention Phase
Coronary Artery Disease
Procedure: Implantation of coronary stent in bifurcation lesion
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: How Should Coronary Artery Stenoses With Significant Side Branch be Stented? A Strategy of Stenting Both Main Vessel and Side Branch Compared to a Strategy of Stenting the Main Vessel and Only Stenting the Side Branch if Necessary.

Resource links provided by NLM:


Further study details as provided by Aarhus University Hospital Skejby:

Primary Outcome Measures:
  • Combined endpoint of: Cardiac death, non-index procedure related myocardial infarction or target lesion revascularisation [ Time Frame: After 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • MACE (cardiac death, non-index procedure related myocardial infarction, stent thrombosis or target lesion revasculation) [ Time Frame: During admission, after 1, 24, 36 and 60 months. ] [ Designated as safety issue: Yes ]
  • Cardiac death. [ Time Frame: During the admission, after 1, 6, 24, 36 and 60 months. ] [ Designated as safety issue: Yes ]
  • Non-index procedure related myocardial infarction during the admission. [ Time Frame: After 1, 6, 24, 36 and 60 months. ] [ Designated as safety issue: Yes ]
  • Stent thrombosis. [ Time Frame: During admission, after 1, 6, 24, 36 and 60 months. ] [ Designated as safety issue: Yes ]
  • Total mortality [ Time Frame: During admission, after 1, 6, 24, 36 and 60 months and 10 years. ] [ Designated as safety issue: Yes ]
  • target lesion revascularisation. [ Time Frame: During admission, after 1, 6, 24, 36 and 60 months. ] [ Designated as safety issue: Yes ]
  • target vessel revascularisation. [ Time Frame: During admission, after 1, 6, 24, 36 and 60 months. ] [ Designated as safety issue: Yes ]
  • Index procedure related myocardial infarction based on biomarkers (CK-MB mass, TNT/TNI [ Time Frame: During hospital period, 1, 8, 24, 36 and 60 months ] [ Designated as safety issue: Yes ]
  • CCS angina class [ Time Frame: After 6, 8, 24, 36 and 60 months. ] [ Designated as safety issue: Yes ]

Enrollment: 450
Study Start Date: December 2008
Estimated Study Completion Date: December 2020
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: "No side branch treatment" group
Implantation of coronary stent in bifurcation lesion
Procedure: Implantation of coronary stent in bifurcation lesion
Implantation of coronary stent in bifurcation lesion with no side branch treatment
Other Names:
  • PCI
  • PTCA
Experimental: "Stenting of main vessel and side branch" group
Implantation of coronary stent in bifurcation lesion
Procedure: Implantation of coronary stent in bifurcation lesion
Implantation of coronary stent in bifurcation lesion with stenting of main vessel and side branch
Other Names:
  • PCI
  • PTCA

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Stable or unstable angina pectoris or silent angina pectoris.
  • Genuine bifurcation lesion ( Medina type 1,1,1 or 1,0,1 or 0,1,1)
  • 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 >2.75 mm.
  • Signed informed consent.

Exclusion Criteria:

  • ST-elevation infarction within 24 hours.
  • Side branch lesion length >15 mm.
  • 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: NCT01496638

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

No publications provided

Responsible Party: Jens Flensted Lassen, Primary investigator, Aarhus University Hospital Skejby
ClinicalTrials.gov Identifier: NCT01496638     History of Changes
Other Study ID Numbers: 20080192
Study First Received: December 19, 2011
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
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 27, 2014