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: July 24, 2013
Last verified: July 2013
  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 ]

Estimated Enrollment: 400
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

Detailed Description:

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.
  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: 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
Coronary Stenosis
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on July 28, 2014