NCT01496638

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).

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
450

participants targeted

Target at P75+ for not_applicable coronary-artery-disease

Timeline
Completed

Started Dec 2008

Longer than P75 for not_applicable coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

December 19, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 21, 2011

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
13.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

January 2, 2026

Status Verified

December 1, 2025

Enrollment Period

4 years

First QC Date

December 19, 2011

Last Update Submit

December 29, 2025

Conditions

Coronary Artery Disease

Keywords

PCIBifurcation lesion

Outcome Measures

Primary Outcomes (1)

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

    After 6 months

Secondary Outcomes (9)

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

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

  • Cardiac death.

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

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

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

  • Stent thrombosis.

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

  • Total mortality

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

  • +4 more secondary outcomes

Study Arms (2)

"No side branch treatment" group

EXPERIMENTAL

Implantation of coronary stent in bifurcation lesion

Procedure: Implantation of coronary stent in bifurcation lesion

"Stenting of main vessel and side branch" group

EXPERIMENTAL

Implantation of coronary stent in bifurcation lesion

Procedure: Implantation of coronary stent in bifurcation lesion

Interventions

Implantation of coronary stent in bifurcation lesionPROCEDURE

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

Also known as: PCI, PTCA
"No side branch treatment" group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital

Skejby, Aarhus N, 8200, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 32076558DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Niels R Holm, MD

    MD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

December 19, 2011

First Posted

December 21, 2011

Study Start

December 1, 2008

Primary Completion

December 1, 2012

Study Completion

January 1, 2026

Last Updated

January 2, 2026

Record last verified: 2025-12

Locations

DK(1)