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Coronary Artery DiseaseBIF IVNCT01496638

The Nordic-Baltic Bifurcation Study IV

A study testing Implantation of coronary stent in bifurcation lesion in people with Coronary Artery Disease, run by Evald Hoej Christiansen at 1 site in Denmark.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease
What is being tested?
Implantation of coronary stent in bifurcation lesion
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
450 participants
Where
1 siteDenmark
Study dates
Dec 2008to Jan 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Aarhus University Hospital

    Skejby, Aarhus N, 8200

Other trials in Denmark

About this study

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.

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).

Read the 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.
Being tested
Implantation of coronary stent in bifurcation lesion
Keywords
PCI, Bifurcation lesion
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Implantation of coronary stent in bifurcation lesionProcedure or surgery

    Also called PCI, PTCA

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

  • Implantation of coronary stent in bifurcation lesionProcedure or surgery

    Also called PCI, PTCA

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

Study groups in NCT01496638
Study groupRoleWhat they receive
"No side branch treatment" groupExperimentalImplantation of coronary stent in bifurcation lesion
Receives: Procedure: Implantation of coronary stent in bifurcation lesion
"Stenting of main vessel and side branch" groupExperimentalImplantation of coronary stent in bifurcation lesion
Receives: Procedure: Implantation of coronary stent in bifurcation lesion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Combined endpoint of: Cardiac death, non-index procedure related myocardial infarction or target lesion revascularisation

    Measured: After 6 months

Secondary outcomes (9)

  1. MACE (cardiac death, non-index procedure related myocardial infarction, stent thrombosis or target lesion revasculation)

    Measured: During admission, after 1, 24, 36 and 60 months.

  2. Cardiac death.

    Measured: During the admission, after 1, 6, 24, 36 and 60 months.

  3. Non-index procedure related myocardial infarction during the admission.

    Measured: After 1, 6, 24, 36 and 60 months.

  4. Stent thrombosis.

    Measured: During admission, after 1, 6, 24, 36 and 60 months.

  5. Total mortality

    Measured: During admission, after 1, 6, 24, 36 and 60 months and 10 years.

  6. target lesion revascularisation.

    Measured: During admission, after 1, 6, 24, 36 and 60 months.

  7. target vessel revascularisation.

    Measured: During admission, after 1, 6, 24, 36 and 60 months.

  8. Index procedure related myocardial infarction based on biomarkers (CK-MB mass, TNT/TNI

    Measured: During hospital period, 1, 8, 24, 36 and 60 months

  9. CCS angina class

    Measured: After 6, 8, 24, 36 and 60 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Dec 2011 (estimated)
  2. Study startDec 2008
  3. Primary completionDec 2012
  4. Study completionJan 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
450 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01496638
Sponsor's protocol ID
20080192
Acronym
BIF IV
Status last verified
Dec 2025
First submitted
19 Dec 2011
Last updated
2 Jan 2026
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 32076558

Questions about this trial

What is this clinical trial studying?

A study testing Implantation of coronary stent in bifurcation lesion in people with Coronary Artery Disease, run by Evald Hoej Christiansen at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Combined endpoint of: Cardiac death, non-index procedure related myocardial infarction or target lesion revascularisation (time frame: After 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01496638, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2026.

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