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

December 19, 2011
September 4, 2014
December 2008
December 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01496638 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
The Nordic-Baltic Bifurcation Study IV
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.

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).

Design:

  • Randomised open multicentre trial.

Patients:

  • Number 450.

Randomisation:

  • No side branch treatment group or stenting of main vessel and side branch group.

Evaluation of endpoints:

  • Primary and secondary endpoints will be assessed by an independent endpoint committee.
  • The endpoint committee will consist of experienced cardiologists with professor Kristian Thygesen, Aarhus Universitetshospital, as chairman.

Sample size calculation:

  • A total of 225 patients will be included in each group, in total 450 patients. We expect a primary endpoint rate of 10% (cardiac death, non-procedure related myocardial infarction related to index lesion or TLR after 6 months) in the 1- stent strategy group and of 3% in the 2-stent strategy group. With an alpha of 5% and a strength of 80%, 194 patients will be needed in each group (two-sided chi-square test) to demonstrate this difference. The expected primary endpoint rate after 6 months is based on 6 months MACE rates and on the angiographic results in our previously published studies. In these studies, a 6 months MACE rate of 3.7% was found in the culotte group of the Nordic Stent Technique Study. Besides, an angiographic restenosis rate of 19.2% in the 1-stent strategy group in the Nordic Bifurcation Study is estimated to translate to a MACE rate of approximately 10% in the present study.

Analysis of the population:

  • The results will be analyzed according to the intention-to-treat principle.

Data management:

  • The study is reported to Datatilsynet (The Danish Data Protection Agency) and the agency's guidelines for data management will be followed.

Dedicated case record forms (CRF) will be used and faxed to PCI research, Cardiac Cath. Lab., Aarhus University Hospital, Skejby, DK-8200 Aarhus N, Denmark. Data will be stored in an Access database and double data entry will be used as quality control. There will be a log of accesses and attempt of accesses. Back-up data and original data will be cryptotized.

Monitoring of the study:

  • The study will be monitored according to the GCP rules by independent professionals. During the study period, monitors will have regular contact to the participating departments to ensure that the trial is conducted in compliance with the protocol, GCP and applicable regulatory requirements

Publication:

  • Results, positive as well as negative, will be published in an international cardiovascular journal. Publication and author issues will be decided by the steering committee on basis of general involvement in the study (drafting of protocol, core lab. function, end point committee membership, etc.) and of number of included patients.
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Coronary Artery Disease
  • Procedure: Implantation of coronary stent in bifurcation lesion
    Implantation of coronary stent in bifurcation lesion with no side branch treatment
    Other Names:
    • PCI
    • PTCA
  • 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
  • Experimental: "No side branch treatment" group
    Implantation of coronary stent in bifurcation lesion
    Intervention: Procedure: Implantation of coronary stent in bifurcation lesion
  • Experimental: "Stenting of main vessel and side branch" group
    Implantation of coronary stent in bifurcation lesion
    Intervention: Procedure: Implantation of coronary stent in bifurcation lesion
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
450
December 2020
December 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01496638
20080192
Yes
Jens Flensted Lassen, Aarhus University Hospital Skejby
Jens Flensted Lassen
Johnson & Johnson
Principal Investigator: Leif Thuesen, MD Director Cardiac Lab, AUH, Skejby
Aarhus University Hospital Skejby
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP