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The Nordic-Baltic Bifurcation Study IV (BIF IV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01496638
Recruitment Status : Active, not recruiting
First Posted : December 21, 2011
Last Update Posted : January 7, 2021
Sponsor:
Collaborator:
Johnson & Johnson
Information provided by (Responsible Party):
Niels Ramsing Holm, Aarhus University Hospital Skejby

Brief Summary:

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 or disease Intervention/treatment Phase
Coronary Artery Disease Procedure: Implantation of coronary stent in bifurcation lesion Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Actual Study Start Date : December 2008
Actual Primary Completion Date : December 2012
Estimated Study Completion Date : December 2025

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Combined endpoint of: Cardiac death, non-index procedure related myocardial infarction or target lesion revascularisation [ Time Frame: After 6 months ]

Secondary Outcome Measures :
  1. 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. ]
  2. Cardiac death. [ Time Frame: During the admission, after 1, 6, 24, 36 and 60 months. ]
  3. Non-index procedure related myocardial infarction during the admission. [ Time Frame: After 1, 6, 24, 36 and 60 months. ]
  4. Stent thrombosis. [ Time Frame: During admission, after 1, 6, 24, 36 and 60 months. ]
  5. Total mortality [ Time Frame: During admission, after 1, 6, 24, 36 and 60 months and 10 years. ]
  6. target lesion revascularisation. [ Time Frame: During admission, after 1, 6, 24, 36 and 60 months. ]
  7. target vessel revascularisation. [ Time Frame: During admission, after 1, 6, 24, 36 and 60 months. ]
  8. 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 ]
  9. CCS angina class [ Time Frame: After 6, 8, 24, 36 and 60 months. ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01496638


Locations
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Denmark
Aarhus University Hospital
Skejby, Aarhus N, Denmark, 8200
Sponsors and Collaborators
Niels Ramsing Holm
Johnson & Johnson
Investigators
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Principal Investigator: Niels R Holm, MD MD
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Niels Ramsing Holm, MD, Aarhus University Hospital Skejby
ClinicalTrials.gov Identifier: NCT01496638    
Other Study ID Numbers: 20080192
First Posted: December 21, 2011    Key Record Dates
Last Update Posted: January 7, 2021
Last Verified: January 2021
Keywords provided by Niels Ramsing Holm, Aarhus University Hospital Skejby:
PCI
Bifurcation lesion
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases