NCT00914199

Brief Summary

Should we, or should we not, perform dilatation of the side branch through the main vessel stent, if there is acceptable blood flow in the side branch?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
477

participants targeted

Target at P75+ for not_applicable coronary-artery-disease

Timeline
Completed

Started Apr 2007

Longer than P75 for not_applicable coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
completed

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

April 2, 2007

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 3, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 4, 2009

Completed
12.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2021

Completed
Last Updated

January 2, 2026

Status Verified

December 1, 2025

Enrollment Period

1.4 years

First QC Date

June 3, 2009

Last Update Submit

December 29, 2025

Conditions

Coronary Artery Disease

Keywords

PCIBifurcation lesion

Outcome Measures

Primary Outcomes (1)

  • Combined end point of: cardiac death, index lesion myocardial infarction, stent thrombosis or target lesion revascularisation

    After 6 months

Secondary Outcomes (15)

  • MACE (cardiac death, myocardial infarction, stent thrombosis or target vessel revascularisation)

    during hospital period, after 1, 8, and 14 months, 2 and 3 years

  • Cardiac death

    during hospital period, after 1, 8 and 14 months, 2 and 3 years

  • Myocardial infarction

    during hospital period, after 1, 8 and 14 months, 2 and 3 years

  • Stent thrombosis

    during hospital period, after 1, 8 and 14 months, 2 and 3 years

  • Target vessel revascularisation

    during hospital period, after 1, 8 and 14 months, 2 and 3 years

  • +10 more secondary outcomes

Study Arms (2)

Kissing balloon post-dilatation

EXPERIMENTAL

Percutaneous coronary intervention with implantation of stent using kissing balloon dilatation

Procedure: Percutaneous coronary intervention (PCI)

No kissing balloon post-dilatation

EXPERIMENTAL

Percutaneous coronary intervention with implantation of stent and not using kissing balloon postdilatation

Procedure: Percutaneous coronary intervention (PCI)

Interventions

Percutaneous coronary intervention (PCI)PROCEDURE

Implantation of coronary stent in bifurcation lesion.

Also known as: Percutaneous coronary intervention technique, PCI, PTCA
Kissing balloon post-dilatationNo kissing balloon post-dilatation

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Stable or unstable angina pectoris. -Bifurcation lesion of "LAD/diagonal", "Cx/obtuse marginal", "RCA--
  • PDA/posterola¬te¬ral branch" or "LM/Cx/LAD".
  • Diameter of main vessel by visual estimate \> 2.5 mm.
  • Diameter of side branch by visual estimate \> 2.25 mm.
  • Signed informed consent

You may not qualify if:

  • Age \< 18 years.
  • ST-elevation infarction within 24 hours.
  • 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, 8200, Denmark

Location

Related Publications (1)

  • Niemela M, Kervinen K, Erglis A, Holm NR, Maeng M, Christiansen EH, Kumsars I, Jegere S, Dombrovskis A, Gunnes P, Stavnes S, Steigen TK, Trovik T, Eskola M, Vikman S, Romppanen H, Makikallio T, Hansen KN, Thayssen P, Aberge L, Jensen LO, Hervold A, Airaksinen J, Pietila M, Frobert O, Kellerth T, Ravkilde J, Aaroe J, Jensen JS, Helqvist S, Sjogren I, James S, Miettinen H, Lassen JF, Thuesen L; Nordic-Baltic PCI Study Group. Randomized comparison of final kissing balloon dilatation versus no final kissing balloon dilatation in patients with coronary bifurcation lesions treated with main vessel stenting: the Nordic-Baltic Bifurcation Study III. Circulation. 2011 Jan 4;123(1):79-86. doi: 10.1161/CIRCULATIONAHA.110.966879. Epub 2010 Dec 20.

    PMID: 21173348DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Endovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

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

June 3, 2009

First Posted

June 4, 2009

Study Start

April 2, 2007

Primary Completion

September 1, 2008

Study Completion

November 1, 2021

Last Updated

January 2, 2026

Record last verified: 2025-12

Locations

DK(1)