The Nordic-Baltic Bifurcation Study IV

NCT ID: NCT01496638

Last Updated: 2026-01-02

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 450 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2026-01-31

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).

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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

"No side branch treatment" group

Implantation of coronary stent in bifurcation lesion

Group Type: EXPERIMENTAL

Implantation of coronary stent in bifurcation lesion

Intervention Type: PROCEDURE

Implantation of coronary stent in bifurcation lesion with no side branch treatment

"Stenting of main vessel and side branch" group

Implantation of coronary stent in bifurcation lesion

Group Type: EXPERIMENTAL

Implantation of coronary stent in bifurcation lesion

Intervention Type: PROCEDURE

Implantation of coronary stent in bifurcation lesion with stenting of main vessel and side branch

Interventions

Implantation of coronary stent in bifurcation lesion

Implantation of coronary stent in bifurcation lesion with no side branch treatment

Intervention Type: PROCEDURE

Implantation of coronary stent in bifurcation lesion

Implantation of coronary stent in bifurcation lesion with stenting of main vessel and side branch

Intervention Type: PROCEDURE

Other Intervention Names

PCI; PTCA; PCI; PTCA

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johnson & Johnson

INDUSTRY

Sponsor Role: collaborator

Evald Hoej Christiansen

OTHER

Sponsor Role: lead

Responsible Party

Evald Hoej Christiansen

MD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Niels R Holm, MD

Role: PRINCIPAL_INVESTIGATOR

MD

Locations

Aarhus University Hospital

Skejby, Aarhus N, Denmark

Countries

Denmark

References

Kumsars I, Holm NR, Niemela M, Erglis A, Kervinen K, Christiansen EH, Maeng M, Dombrovskis A, Abraitis V, Kibarskis A, Trovik T, Latkovskis G, Sondore D, Narbute I, Terkelsen CJ, Eskola M, Romppanen H, Laine M, Jensen LO, Pietila M, Gunnes P, Hebsgaard L, Frobert O, Calais F, Hartikainen J, Aaroe J, Ravkilde J, Engstrom T, Steigen TK, Thuesen L, Lassen JF; Nordic Baltic bifurcation study group. Randomised comparison of provisional side branch stenting versus a two-stent strategy for treatment of true coronary bifurcation lesions involving a large side branch: the Nordic-Baltic Bifurcation Study IV. Open Heart. 2020 Jan 19;7(1):e000947. doi: 10.1136/openhrt-2018-000947. eCollection 2020.

Reference Type: DERIVED

PMID: 32076558 (View on PubMed)

Other Identifiers

20080192

Identifier Type: -

Identifier Source: org_study_id