The Nordic-Baltic Bifurcation Study IV

Coronary Artery Disease Clinical Trial

— BIF IV  

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01496638
• Other study ID #: 20080192
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 2008
• Est. completion date: December 2025

Study information

• Verified date: January 2021
• Source: Aarhus University Hospital Skejby
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 450
• Est. completion date: December 2025
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Procedure:
• Implantation of coronary stent in bifurcation lesion
Implantation of coronary stent in bifurcation lesion with no side branch treatment
• Implantation of coronary stent in bifurcation lesion
Implantation of coronary stent in bifurcation lesion with stenting of main vessel and side branch

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Skejby	Aarhus N

Sponsors (2)

Lead Sponsor	Collaborator
Niels Ramsing Holm	Johnson & Johnson

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Combined endpoint of: Cardiac death, non-index procedure related myocardial infarction or target lesion revascularisation		After 6 months
Secondary	MACE (cardiac death, non-index procedure related myocardial infarction, stent thrombosis or target lesion revasculation)		During admission, after 1, 24, 36 and 60 months.
Secondary	Cardiac death.		During the admission, after 1, 6, 24, 36 and 60 months.
Secondary	Non-index procedure related myocardial infarction during the admission.		After 1, 6, 24, 36 and 60 months.
Secondary	Stent thrombosis.		During admission, after 1, 6, 24, 36 and 60 months.
Secondary	Total mortality		During admission, after 1, 6, 24, 36 and 60 months and 10 years.
Secondary	target lesion revascularisation.		During admission, after 1, 6, 24, 36 and 60 months.
Secondary	target vessel revascularisation.		During admission, after 1, 6, 24, 36 and 60 months.
Secondary	Index procedure related myocardial infarction based on biomarkers (CK-MB mass, TNT/TNI		During hospital period, 1, 8, 24, 36 and 60 months
Secondary	CCS angina class		After 6, 8, 24, 36 and 60 months.